Common Implementation Strategy for the Water Framework Directive. Fluoranthene

Size: px
Start display at page:

Download "Common Implementation Strategy for the Water Framework Directive. Fluoranthene"

Transcription

1 Common Implementation Strategy for the Water Framework Directive Environmental Quality Standards (EQS) Substance Data Sheet Priority Substance No. 15 Fluoranthene CAS-No Final version Brussels, 15 January 2005

2 Disclaimer This data sheet provides background information on the setting of the Environmental Quality Standard in accordance with Article 16 of the Water Framework Directive (2000/60/EC). The information was compiled, evaluated and used as outlined in the Manual [4] and has been discussed in a consultative process with the Expert Advisory Forum on Priority Substances and the Expert Group on Quality Standards. Furthermore, it has been peer-reviewed by the SCTEE [14]. The substance data sheet may, however, not necessarily represent the views of the European Commission. New upcoming information was considered and included up to the date of finalisation of this data sheet. Information becoming available after finalisation of this document will be evaluated in the review process of priority substances according to Art. 16(4) of the Water Framework Directive. If necessary, the Environmental Quality Standard substance data sheets will then be revised in the light of technical and scientific progress.

3 1 Identity of substance Priority Substance No: 15 Fluoranthene CAS-No: Classification WFD Priority List * : PS * PS: priority substance; PHS: priority hazardous substance; PSR: priority substance under review according to Decision 2455/ Proposed quality standards 2.1 Overall quality standards Ecosystem Quality Standard Quality Standard rounded values AA-QS all types of surface waters covered by the WFD 0.09 µg/l corresponding conc. in: freshwater SPM 1069 µg/kg dry wt saltwater SPM 1247 µg/kg dry wt 0.1 µg/l corresponding conc. in: freshwater SPM 1100 µg/kg dry wt saltwater SPM 1200 µg/kg dry wt Comment: MAC-QS (ECO) 0.9 µg/l 1 µg/l see section 8.1 The suggested overall QS is referring to the protection of the benthic community (see 8.2 & 8.6). 2.2 Specific quality standards Protection Objective # Quality Standard Comment: Pelagic community (freshwater and saltwater) Benthic community (sediment) Predators (secondary poisoning) Food uptake by man Abstraction of water intended for human consumption (AWIHC) Water intended for human consumption (WIHC) # 0.12 µg/l corresponding conc. in: freshwater SPM 1425 µg/kg dry wt saltwater SPM 1662 µg/kg dry wt 0.09 µg/l corresponding conc. in: freshwater SPM 1069 µg/kg dry wt saltwater SPM 1247 µg/kg dry wt mg/kg prey (wet wt) the corresponding concentration in water is most probably higher than the suggested overall QS (>0.09 µg/l) derivation of QS not required (also insufficient availability of toxicity data) 0.2 µg/l see section 8.1 see section 8.2 BCF values cover a wide range, the potenitial for biomagnification is not known; however scenario calculations suggest that the proposed overall QS is protective for predators as well; see section 8.3 see section 8.4 A-1 value for ΣPAH in CD 75/440/EEC see section Fluoranthene is not covered by the limit value set in CD 98/83/EC for the sum of certain PAHs; see section 8.5 If justified by substance properties or data available, QS for the different protection objectives are given independently for freshwater environments, transitional waters or coastal and territorial waters - 1 -

4 3 Classification R-Phrases and Labelling Reference: This chemical substance is not classified in the Annex I of Directive 67/548/EEC. [15] 4 Physical and chemical properties Property Value: Master Ref: Ref. in master ref. & comments: Mol. Weight: g/mol [6] Water Solubility mg/l (25 C) [6] [24], [33] Vapour Pressure: 0,7 x 10-3 Pa (20 C); 1,3 x 10-3 Pa (25 C); 6 x 10-6 mm Hg (20 C) [33] [6] [33], [35] 5 Environmental fate and partitioning Property Value: Master Ref: Abiotic degradation Hydrolysis Biodegradation Partition coefficients log Kow (octanol water) Hydrolysis not probable; stable under environmental conditions [6] [41] [37] [6] [5] Ref. in master ref. & comments: [10], [33], [35] Koc (organic carbon-water) Aquifer u L/kg Sediment L/kg (calculated) L/kg [6] [36] [37] [38], [39] Bioaccumulation BCFs: Fish Crustacea (Daphnia magna) Mollusca (Crassostrea virginica) Sediment log Koc log Koc 5.16 used in [5] 1,700 (calculated) 1,740 10,000 l/kg [5] [6] [33] [4] [33] Refs. in appendix 5 of [5] - 2 -

5 6 Effect data (aquatic environment) Table 6.1: Overview on toxicity data of most sensitive species from different sources (master reference) (*: fw = freshwater, sw = saltwater) Species Taxon. Grp. Medium * Duration Effect Endpoint Value Unit Master Ref. Reference in master ref. Freshwater Ceriodaphnia dubia Crustacea fw 7 d Reproduction, EC µg/l [7] Mortality Scenedesmus subspicatus Alga fw 7 d Growth EC µg/l [6] Kördel et al [23] Brachydanio rerio Pisces fw 41 d Growth, as fish NOEC 6.9 µg/l [5], [6] Hooftman et al length Growth, as wet NOEC 22 µg/l weight Mortality NOEC 69 µg/l Pseudokirchneriella subcapitata Alga fw 72 h Growth EC µg/l [7] Daphnia magna Crustacea fw 21 d Reproduction NOEC 15 µg/l [6] Kördel et al [23] Hyallela azteca Crustacea fw 10 d Mortality NOEC 18 µg/l [7] Suedel et Rodgers (1996) Chironomus tentans Insecta fw 10 d Mortality NOEC 30 µg/l [7] Suedel et Rodgers (1996) Lemna gibba Planta fw 8 d Growth NOEC 500 µg/l [7] Ren et al. (1994) Rana catesbeiana Amphibia fw 4 d Behaviour NOEC 11 µg/l [7] Walker et al. (1998) Pimephales promelas Pisces fw 5 min Avoidance NOEC 8.6 µg/l [7] Farr et al. (1995) Scenedesmus subspicatus Alga fw 7 d Growth EC50 12 µg/l [6] Kördel et al [23] Daphnia magna Crustacea fw 10.8 hours Mortality LC50 9 µg/l [1] Newsted and Giesy (1987) Gammarus pulex Crustacea fw 14 day Mortality LC50 96 mg/l [1] Boxall (1996) Ictalurus punctatus Pisces fw 4 d Mortality LC50 36 µg/l [6] Gendusa 1990 [19] Sediment, freshwater Rhepoxynius abronius Crustacea fw, interstitial 10 d Mortality NOEC 12 µg/l [7] Swartz et al. (1989) Hyallela azteca Crustacea fw, sediment 10 d Mortality NOEC < 12.9 mg/kg dw [7] Suedel et Rodgers (1996) Chironomus tentans Insecta fw, sediment 10 d Mortality NOEC 13.9 mg/kg dw [7] Suedel et Rodgers (1996) Diporeia sp. Crustacea fw, sediment 30 d Mortality NOEC < 15.6 mg/kg dw [8] Driscoll et al. (1997) Stylaria lacustris Annelida fw, sediment 10 d Mortality NOEC 26.8 mg/kg dw [7] Suedel et Rodgers (1996) Rhepoxynius abronius Crustacea fw, sediment 10 d Mortality LC mg/kg dw [8] Swartz et al. (1990) Corophium spinicorne Crustacea fw, sediment 10 d Mortality LC mg/kg dw [8] Swartz et al. (1990) Saltwater Mytilus edulis Mollusca sw 7 d Immunocompetence NOEC 20 µg/l [7] Coles et al. (1994) Grandidierella japonica Crustacea sw 96 h Behaviour EC50 27 µg/l [6] Boese et al [17] Neanthes arenaceodentata Annelida sw 96 h Mortality LC µg/l [5] Rossi & Neff 1978 Mulinia lateralis Mollusca sw 96 h Larval growth in fluorescent ligth EC µg/l [6] Pelletier et al [29] - 3 -

6 Table 6.2: Mammal oral toxicity data relevant for the assessment of non compartment specific effects relevant for the food chain (secondary poisoning) [9] Species Mus musculus Mouse Duration Endpoint 13 wk NOAEL, based on: nephropathy, increased liver weights, haematological alterations, and other clinical effects mg/kg bw d Reference 125 U.S. EPA Week mouse oral subchronic toxicity study. Prepared by Toxicity Research Laboratories, Ltd., Muskegon, MI for the Office of Solid Waste, Washington, DC. 104 pp (TRL Study No ) 6.2 Summary on endocrine disrupting potential Effects of fluoranthene on endocrine regulation are not mentioned in [2]. 7 Effect data (human health) Table 7.1: Effect data relevant to human health aspects Effect Summarised information chronic oral toxicity: [13] US-EPA oral reference dose (RfD): 40 µg/kg bw/ day, based on a 13 wk study with mice. The NOAEL: of this study is 125 mg/kg bw/d and the LOAEL 250 mg/kg bw/d. Critical effects were nephropathy, increased liver weights, and changes in clinical and hematological parameters. The uncertainty factor used to derive the RfD is This UF reflects 10 each for intra- and interspecies variability, 10 for the use of a subchronic study for the derivation of a chronic RfD, and 3 for lack of supporting reproductive/developmental toxicity and toxicity data in a second species. [13] mutagenicity: Experimental results are ambigous. Positive and negative results have been observed with different strains of Salmonella thyphimurium. Positive and negative results have also been obtained with hamster cells. A test with human lymphoblasts was positive. [7] cancerogenicity: Experimental results on cancerogenicity have been judged insufficient. In the absence of data on humans fluoranthene has been classified as non carcinogenic for humans (class D, IARC 1983, cited in [7] )

7 8 Calculation of quality standards 8.1 Quality standards for water Long-term as well as short-term toxicity data are available for freshwater and marine species, respectively. On the basis of the available data no apparent differences in the sensitivity of freshwater or saltwater organisms can be identified. Therefore it is suggested to use the combined data set for the derivation of quality standards for both freshwater and saltwater environments. Freshwater NOECs (or EC10 values as NOEC surrogates) are available for algae, plants, crustaceans, fish, amphibians, insects and molluscs. The lowest NOEC is 1.2 µg/l (EC10 of Ceriodaphnia dubia). As NOECs for species of at least three different trophic levels are available the appropriate assessment factor is 10 [4]. QS freshwater = 0.12 µg Fluoranthene /l An experimental Kp susp is not available. But the Kp susp can be calculated based on the Koc as described in the TGD (section ) [3]. It is proposed to use log Koc 5.16 for the calculation. It was used in the Netherlands for the calculation of the MPC for fluoranthene [5] and it can be regarded as a mean of the Koc range cited in the available reports (see section 5 of this data sheet). Kp susp [l/kg] = foc (0.1) * Koc (144,544) = 14,454 l/kg As the log Kp susp is >3, the trigger to calculate the corresponding concentration to the QS freshwater in SPM is met and therefore QS SPM.freshwat is derived (see section of the final report [4] ). QS freshwater [0.12 µg/l] QS SPM.freshwat = = 1425 µg/kg SPM (dry wt) C SPM [15 mg/l] * 10-6 [kg/mg] + Kp -1 [(14,454 l/kg) -1 ] Transitional, coastal and territorial waters Long-term tests with freshwater species from more than 3 different taxonomic groups and tests with additional marine taxonomic groups (marine annelids and molluscs) are available. The marine species have comparable sensitivities to the freshwater species (this was also the general conclusion drawn from a comparison of freshwater and saltwater toxicity data of several PAHs [5] ). Thus, it is suggested, in accordance with the provisions of the TGD to pool the data and set the same quality standard for saltwater as derived for freshwater: QS saltwater = QS freshwater As the log Kp susp is >3, the corresponding concentration to the QS saltwater in SPM is calculated (see section of the Manual [4] ). For the TGD standard water, the concentration corresponding to the QS saltwater is that calculated for freshwater (see above). However, the SPM concentration in marine waters is significantly lower than in freshwater (discussed in the context of the marine risk assessment: approx. 3 mg/l as standard concentration). Therefore, the quality standard is, as an example, also calculated for a SPM concentration of 3 mg/l: - 5 -

8 QS freshwater [0.12 µg/l] QS SPM.saltwat = = 1662 µg/kg SPM (dry wt) C SPM [3 mg/l] * 10-6 [kg/mg] + Kp -1 [(14,454 l/kg) -1 ] Quality standard accounting for transient concentration peaks (MAC-QS) Acute toxicity data are available for freshwater and marine organisms of different taxonomic groups (algae, crustacea, fish, annelida, mollusca). The lowest short-term acute toxicity value 1 is the Daphnia magna 10.8 h LC50 of 9 µg/l (Newsted amd Giesy, 1987 cited by [1] ). The MAC-QS is derived on the basis of this LC50 and the guidance given in the TGD on the effects assessment for intermittent releases (section of the Manual [4] ). As the available short term toxicity data cover a wider range of different taxonomic groups it is suggested to use only a reduced assessment factor of 10 (instead of 100). MAC-QS = 0.9 µg Fluoranthene / l The derivation of a separate MAC-QS applicable to transient concentration peaks in coastal and territorial waters is not required as it is not probable that significant peaks occur in these waters. For transitional waters the freshwater MAC-QS may be used. 8.2 Quality standard for sediment As the log Kp susp is >3, the calculation of a quality standard for sediment is required (see table 1a of the Manual [4] ). Several tests with different freshwater sediment organisms (belonging to the taxa crustacea, insecta and annelida) are available. Thus, according to the TGD, the QS for sediment should be calculated by both the assessment factor method and the equilibrium partitioning method Equilibrium partitioning method The equilibrium partitioning approach only considers uptake via the water phase. However, uptake may also occur via other exposure pathways like ingestion of sediment and direct contact with sediment. There is evidence from studies in soil that the proportion of the total dose remains low for chemicals with a log Kow up to 5. For compounds with a log Kow greater than 5 the equilibrium method is used in a modified way. It is recommended in the TGD to increase the PEC sed /PNEC sed ratio by a factor of 10 for the risk assessment. However division of the PNEC water by a factor of 10 will result in the same ratio. Thus, it can be inferred that division of the QS water by a factor of 10 will result in a tentative QS sediment that accounts for possible uptake via the mentioned additional routes of exposure. As the available log Kow.s of fluoranthene are in the range of the QS water is divided by a factor of 10. It is proposed to use log Kow 5.16 for the assessment (see section 5 of this data sheet, kind of intermediate). 1 In [6] two results (EC and 900 µg/l) differing by a factor more than 1000 for acute tests with the marine mollusc Mulinia lateralis are cited (see table 6.1 of this data sheet). No explanation on possible reasons for this huge difference is given in [6]. Therefore the results are not considered for the derivation of the MAC-QS

9 Kp SPM-water [3,614 m 3 /m 3 ] QS sed.wet_weight [mg.kg -1 ] = * 1,000 * QS water [ mg/l] * 10-1 bulk density SPM.wet [1,150 kg/m 3 ] with: K SPM-water = f solid (0.1) * Kp susp (14,454 l/kg) / 1,000 * RHO solid (2,500 kg/m 3 ) = 3,614 m 3 /m 3 (section of [3] ) bulk density SPM.wet = 1,150 kg/m 3 1,000 = conversion factor m 3 /kg to l/kg 10-1 = factor to account for possible additional uptake routes for substances with log Kow >5 The TGD defines wet SPM as 90% vol/vol water (density 1 kg/l) and 10% vol/vol solids (density 2.5 kg/l), thus giving a wet density of (0.9 1) + ( ) = 1.15 kg/l. The dry weight of solids is therefore 0.25 kg (per litre wet SPM) and thus the wet:dry ratio is 1.15/0.25 = 4.6. This results in the following quality standard for both freshwater and marine sediment (wet and dry weight): QS sediment 37.7 µg/kg (wet wt) 173 µg/kg (dry wt) Assessment factor method There are 6 subchronic tests with sediment dwelling organisms from 3 different taxonomic groups (crustacea, insecta, annelida) available (see table 6.1). Endpoints are either NOECs or LC50s, for the most sensitive species only a LC50 is available. The TGD foresees the use of 1000 as assessment factor for short-term acute tests and factors of for long-term NOECs/EC10s, depending on the quantity and quality of the data available. Because the 4 NOECs available refer to subchronic rather than to real long-term exposure and because there is no NOEC available for the most sensitive species, it is proposed to use an AF of 100 to derive the QS sediment based on the lowest NOEC (which might be rather considered as LOEC) 2 : QS sediment = NOEC (<12.9 mg/kg) / AF 100 = 129 µg Fluoranthene /kg sediment (dry weight) The quality standard derived on the basis of experimental findings is very similar to the corresponding value derived with the Equilibrium Partitioning method. Therefore it is suggested to adopt the toxicity test based QS as QS sediment. The TGD normally foresees to apply more stringent assessment factors for the marine effects assessment in case toxicity data referring to marine organisms are not available (which is the case with regard to tests with marine sediment organisms). However, as tests with pelagic marine taxonomic groups show comparable sensitivities to the pelagic freshwater species, it appears reasonable to assume that the sensitivity of freshwater and saltwater sediment organisms towards fluoranthene is as well not significantly different. It is therefore suggested to set the same quality standard for marine sediment as derived for freshwater sediment Calculation of a water concentration corresponding to the QS sediment As the QS sediment is based on real sediment data (i.e. was not derived by transforming water concentrations with the Equilibrium Partitioning method), it is necessary to calculate the 2 The TGD does not provide conclusive guidance regarding the appropriate size of the AF for a data set as available for fluoranthene - 7 -

10 corresponding concentration in water. To this end, the equilibrium partitioning equation is used (see 8.2.1): QS sediment.wwt [28 µg/kg] bulk density SPM.wet [1,150 kg/m 3 ] QS water = * = 0.09 µg Fluoranthene /l 1,000 * 0.1 Kp SPM-water [3,614 m 3 /m 3 ] with: K SPM-water = f solid (0.1) * Kp susp (14,454 l/kg) / 1,000 * RHO solid (2,500 kg/m 3 ) = 3,614 m 3 /m 3 (section of [3] ) bulk density SPM.wet = 1,150 kg/m 3 1,000 = conversion factor m 3 /kg to l/kg 10-1 = factor to account for possible additional uptake routes for substances with log Kow >5 QS sediment.wwt = 129 [µg/kg dw] / 4.6 = 28 µg/kg ww The TGD defines wet SPM as 90% vol/vol water (density 1 kg/l) and 10% vol/vol solids (density 2.5 kg/l), thus giving a wet density of (0.9 1) + ( ) = 1.15 kg/l. The dry weight of solids is therefore 0.25 kg (per litre wet SPM) and thus the wet:dry ratio is 1.15/0.25 = 4.6. The water concentration corresponding to the QS sediment is lower than the quality standard derived for the protection of the pelagic community. Therefore, the value of 0.09 µg fluoranthene /l is suggested as water quality standard. QS freshwater = QS saltwater = 0.09 µg Fluoranthene / l The corresponding concentrations in SPM are calculated as follows (see 8.1 for details): QS freshwater [0.09 µg/l] QS SPM.freshwat = = 1069 µg/kg SPM (dry wt) C SPM [15 mg/l] * 10-6 [kg/mg] + Kp -1 [(14,454 l/kg) -1 ] QS freshwater [0.09 µg/l] QS SPM.saltwat = = 1247 µg/kg SPM (dry wt) C SPM [3 mg/l] * 10-6 [kg/mg] + Kp -1 [(14,454 l/kg) -1 ] 8.3 Secondary poisoning of top predators BCFs up to 10,000 have been found for fluoranthene. Thus the derivation of a quality standard referring to secondary poisoning is required. As follow-up to the Workshop of the Expert Group on Quality Standards (12-16 May, Brussels), France submitted a NOAEL obtained for mice that is suitable to derive a QS referring to secondary poisoning (see tab. 6.2). According to the TGD (table 22 of [3] ), the 90 d NOAEL of 125 mg/kg d can be converted into a NOEC by multiplying it with a body weight / daily food intake conversion factor of 8.3: NOEC food = 125 * 8.3 = mg fluoranthene /kg food The appropriate assessment factor to derive the PNEC ( QSsecpois.biota) based on a NOEC food of a subchronic 90 d study is 90 (table 8 of [4] ). QS secpois.biota = NOEC food ( mg/kg) / AF 90 = mg/kg prey (wet wt) - 8 -

11 Reported BCF values for fish and crustaceans are in the range of 1,740 (see section 5) but the BCF reported for the oyster Crassostrea virginica is considerably higher (10,000). Information the potential for biomagnification (i.e. BMF figures) is not available for fluorathene. According to the provisions given in the TGD [3], biomagnification factors (BMF) shall be taken into account when assessing the risk for secondary poisoning. Ideally the BMF shall be based on measured data but if such data are not available the use of default values is recommended. These default values are defined in the TGD based on the Kow or the BCF of the substance (see sections and of the TGD [3] for details). For substances with a BCF < 2000 no BMF factors need to be considered whereas for substances with a BCF >5000 the use of a default BMF of 10 is suggested for freshwater environments and for marine environments the use of a BMF of 100 (10*10). The higher default BMF for the marine environment is recommended in order to take account of the more complex and longer trophic pathways in marine ecosystems. Some scenario calculations may highlight the potential of fluoranthene for secondary poisoning (table 8.1). The QS secpois.water is calculated as follows: QS secpois.water = QS secpois.biota (11.53 [mg/kg prey]) / BCF * BMF Table 8.1: Scenario calculations for "safe" water concentrations with respect to secondary poisoning Scenario BCF BMF freshwater BMF marine QS secpois.freshw QS secpois.saltw Fish/Crustaceans 1,740 No TGD default No TGD default 6.63 µg/l 6.63 µg/l as prey Crassostrea as prey 10, (TGD default) Crassostrea as prey (without default BMFs) 100 (TGD default) 0.15 µg/l µg/l 10, µg/l 1.15 µg/l From the figures calculated in table 8.1 it can be concluded that the water based quality standard required to protect the benthic community (0.09 µg/l) is also suitable to protect predators from secondary poisoning. The default BMFs recommended by the TGD are precautionary and it is therefore not very probable that biomagnification up to a factor of 100 occurs in the field. Further, as mussels are filter feeders, the reported BCF of Crassostrea may already partially be due to biomagnification. 8.4 Quality standard referring to food uptake by humans Fluoranthene is not classified with regard to human health. Therefore it is not required to derive a quality standard referring to the protection of human health from adverse effects due to the ingestion of fishery products (trigger criteria not met)

12 8.5 Quality standard for drinking water abstraction The "A1 value" for PAHs (sum) set in the context of Council Directive 75/440/EEC is 0.2 µg/l. Fluoranthene is not covered by the limit value set in Council Directive 98/83/EC for the sum of certain PAHs. Fluoranthene is not classified with regard to human health. Therefore it is not required to derive a provisional drinking water standard (trigger criteria not met). 8.6 Overall quality standard For polyaromatic hydrocarbons, the SCTEE recommended to use a group approach both for the quality standards referring to ecological protection objectives as well as to human health [14]. However, with the current scientific knowledge on environmental behaviour, fate and effects it is not possible to develop such an approach. Therefore, although the proposal of the SCTEE is in principle supported, the quality standard proposals must at present be based on information / data available for the individual PAH-compounds. It is suggested to adopt as overall annual average quality standard (AA-QS) the specific standard derived for the protection of sediment dwelling organisms. If the setting of a specific MAC-QS in areas designated for the abstraction of water intended for human consumption (AWIHC) in accordance with Art. 7 of the WFD is required, that MAC-QS (AWIHC) should be < 0.2 µg/l

13 9 References [1] UK response to request for information relating to quality standards for the Priority List. Submission of data on toxicity, persistence and bioaccumulation by DETR ( of 23 May 2001 by Natasha Robinson) [2] COM(2001)262 final: Communication from the Commission to the Council and the European Parliament on the implementation of the Community Strategy for Endocrine Disrupters a range of substances suspected of interfering with the hormone system of humans and wildlife. (Table 2: substances with evidence of ED or evidence of potential ED which are neither restricted nor currently being addressed under existing Community legislation. Table 3: Substances with evidence of ED or evidence of potential ED, already regulated or being addressed under existing legislation. Table 4: Substances with insufficient data in the BKH Report) [3] Technical Guidance Document on Risk Assessment in Support of Commission Directive 93/67/EEC on Risk Assessment for New Notified Substances and Commission Regulation (EC) No 1488/94 on Risk Assessment for Existing Substances and Directive 98/8/EC of the European Parliament and the Council Concerning the placing of biocidal products on the market. Part II. European Commission Joint Research Centre, EUR EN/2, European Communities Available at the internet-site of the European Chemicals Bureau: [4] Manual of the Methodological Framework Used to Derive Environmental Quality Standards for Priority Substances of the Water Framework Directive. Peter Lepper, Fraunhofer-Institute Molecular Biology and Applied Ecology, 15 November Available at the internet-site of the European Commission: [5] Kalf, DF et al., 1995: Integrated Environmental Quality Objectives for Polycyclic Aromatic Hydrocarbons [PAHs). National Institute of Public Health and the Environment, Bilthoven, The Netherlands. RIVM Report no [6] Frimmel, FH et al., 2001: Ableitung von Qualitätszielen für Kandidatenstoffe der prioritären Liste für die EU-Wasserrahmenrichtlinie. Projektbericht zum Forschungsvorhaben. Stoffdatenblatt für Fluoranthen. [7] Vindimian et al : Complément au SEQ-Eau : méthode de détermination des seuils de qualité pour les substances génotoxiques. Rapport final. Client : Agence de l eau Rhin Meuse. [8] Comments of Germany received after the meeting of the Expert Group on Quality Standards (Brussels, May 2003). by Dieter Schudoma, German EPA, [9] Comments of France received after the meeting of the Expert Group on Quality Standards (Brussels, May 2003). by Vincent Bonnomet, INERIS, [10] Suedel, BC., Rodgers, J.H. 1996: Toxicity of Fluoranthene to Daphnia magana, Hylella azteca, Chironomus tentans, and Stylaria lacustris in Water-Only and Whole Sediment Exposures. Bull. Environ. Contam. Toxicol. 57 : [11] Driscoll, S.K. et al. 1997: Accumulation and Toxicity of Fluoranthene in Sediment Bioassays with Freshwater Amphipods. Environ. Toxicol. Chem. 16, [12] Swartz, R.C. 1990: Toxicity of Fluoranthene in Sediment to Marine Amphipods: A Test of the Equilibrium Partitioning Approach to sediment Quality Criteria. Environ. Toxicol. Chem. 9, [13] Fluoranthene, CASRN ; Reference Dose for Chronic Oral Exposure. Last Revisited 07/01/1993. U.S. Environmental Protection Agency Integrated Risk Information System (IRIS). [14] Opinion of the Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE) on The Setting of Environmental Quality Standards for the Priority Substances included in Annex X of Directive 2000/60/EC in Accordance with Article 16 thereof, adopted by the CSTEE during the 43 rd plenary meeting of 28 May 2004, European Commission Health & Consumer Protection Directorate General, Brussels. [15] ESIS: European Chemicals Bureau ESIS (European Substances Information System), January tick ESIS button, then enter CAS or EINECS number of substance

Common Implementation Strategy for the Water Framework Directive

Common Implementation Strategy for the Water Framework Directive Common Implementation Strategy for the Water Framework Directive Environmental Quality Standards (EQS) Substance Data Sheet Priority Substance No. 7 C 10-13 -Chloralkanes CAS-No. 85535-84-8 Final version

More information

Common Implementation Strategy for the Water Framework Directive. Dichloromethane

Common Implementation Strategy for the Water Framework Directive. Dichloromethane Common Implementation Strategy for the Water Framework Directive Environmental Quality Standards (EQS) Priority Substance No. 11 Dichloromethane CAS-No. 75-09-2 Final version Brussels, 15 January 2005

More information

Common Implementation Strategy for the Water Framework Directive. 1,2-Dichloroethane

Common Implementation Strategy for the Water Framework Directive. 1,2-Dichloroethane Common Implementation Strategy for the Water Framework Directive Environmental Quality Standards (EQS) Substance Data Sheet Priority Substance No. 10 1,2-Dichloroethane CAS-No. 107-06-2 Final version Brussels,

More information

Common Implementation Strategy for the Water Framework Directive. Anthracene

Common Implementation Strategy for the Water Framework Directive. Anthracene Common Implementation Strategy for the Water Framework Directive Environmental Quality Standards (EQS) Priority Substance No. 2 Anthracene CAS-No. 120-12-7 Final version Brussels, 31 July 2005 Disclaimer

More information

Guidance for the derivation of environmental risk limits Part 11. Variables and default values used in the ERL guidance documents. version 1.

Guidance for the derivation of environmental risk limits Part 11. Variables and default values used in the ERL guidance documents. version 1. Guidance for the derivation of environmental risk limits Part 11. Variables and default values used in the ERL guidance documents version 1.0 Colophon RIVM 2015 Parts of this publication may be reproduced,

More information

Common Implementation Strategy for the Water Framework Directive. Cadmium and its Compounds

Common Implementation Strategy for the Water Framework Directive. Cadmium and its Compounds Common Implementation Strategy for the Water Framework Directive Environmental Quality Standards (EQS) Priority Substance No. 6 Cadmium and its Compounds CAS-No. 7440-43-9 Final version Brussels, 31 July

More information

BIFENOX. Molecular weight (g.mol -1 ) Major metabolites observed in the environment Soil:

BIFENOX. Molecular weight (g.mol -1 ) Major metabolites observed in the environment Soil: Bifenox EQS dossier 20 BIFENOX This EQS dossier was prepared by the Sub-Group on Review of the Priority Substances List (under Working Group E of the Common Implementation Strategy for the Water Framework

More information

Common Implementation Strategy for the Water Framework Directive. Tributyltin compounds (TBT-ion)

Common Implementation Strategy for the Water Framework Directive. Tributyltin compounds (TBT-ion) Common Implementation Strategy for the Water Framework Directive Environmental Quality Standards (EQS) Substance Data Sheet Priority Substance No. 30 Tributyltin compounds (TBT-ion) CAS-No. 688-73-3 (36643-28-4)

More information

Common Implementation Strategy for the Water Framework Directive. Diethylhexylphthalate (DEHP)

Common Implementation Strategy for the Water Framework Directive. Diethylhexylphthalate (DEHP) Common Implementation Strategy for the Water Framework Directive Environmental Quality Standards (EQS) Priority Substance No. 12 Diethylhexylphthalate (DEHP) CAS-No. 117-81-7 Final version Brussels, 31

More information

Common Implementation Strategy for the Water Framework Directive. 4-Nonylphenol (branched) and Nonylphenol

Common Implementation Strategy for the Water Framework Directive. 4-Nonylphenol (branched) and Nonylphenol Common Implementation Strategy for the Water Framework Directive Environmental Quality Standards (EQS) Substance Data Sheet Priority Substance No. 24 4-Nonylphenol (branched) and Nonylphenol CAS-No. 84852-15-3

More information

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE)

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE) EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C - Scientific Opinions C2 - Management of scientific committees; scientific co-operation and networks Brussels, C2/VR/csteeop/Benzene/06022003

More information

OPINION ON. 17β-estradiol (E2)

OPINION ON. 17β-estradiol (E2) Scientific Committee on Health and Environmental Risks SCHER OPINION ON "CHEMICALS AND THE WATER FRAMEWORK DIRECTIVE: DRAFT ENVIRONMENTAL QUALITY STANDARDS" 17β-estradiol (E2) SCHER adopted this opinion

More information

Common Implementation Strategy for the Water Framework Directive. Benzene

Common Implementation Strategy for the Water Framework Directive. Benzene Common Implementation Strategy for the Water Framework Directive Environmental Quality Standards (EQS) Substance Data Sheet Priority Substance No. 4 Benzene CAS-No. 71-43-2 Final version Brussels, 15 January

More information

Environmental Risk Assessment Data Metformin hydrochloride

Environmental Risk Assessment Data Metformin hydrochloride Environmental Risk Assessment Data Metformin hydrochloride Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride is an active pharmaceutical

More information

Aminotriazole. 3-Amino-1,2,4-triazole. Triazole herbicide. Use Class: Comments NORMAN Use pattern

Aminotriazole. 3-Amino-1,2,4-triazole. Triazole herbicide. Use Class: Comments NORMAN Use pattern 1 CHEMICAL IDENTITY Common name Chemical name (IUPAC) Synonym(s) Aminotriazole 3-Amino-1,2,4-triazole 1,2,4-Triazol-3-amine, Amitrole, Amitolamitril CAS number 61-82-5 EU number 200-521-5 Chemical class

More information

Case Study: USEPA Benthic Invertebrate Risk Assessment for Endosulfan

Case Study: USEPA Benthic Invertebrate Risk Assessment for Endosulfan U.S. Environmental Protection Agency 1 Case Study: USEPA Benthic Invertebrate Risk Assessment for Endosulfan Presentation to: European Chemicals Agency Topical Scientific Workshop: Risk Assessment for

More information

Aquatic Toxicity and Fate of VigorOx WWT II

Aquatic Toxicity and Fate of VigorOx WWT II Aquatic Toxicity and Fate of VigorOx WWT II June 2014 Table of Contents Acronyms / Definitions 3 Content 4 Background 4 Aquatic Fate of VigorOx WWT II 5 Aquatic Toxicity 6 Aquatic toxicity testing specific

More information

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE) Opinion on the results of the Risk Assessment of: Aniline Environmental part

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE) Opinion on the results of the Risk Assessment of: Aniline Environmental part EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C - Scientific Opinions C2 - Management of scientific committees; scientific co-operation and networks Brussels, C2/GF/csteeop/Aniline/12062003

More information

Risk Assessment Report on 6-acetyl-1,1,2,4,4,7- hexamethyltertraline (AHTN) Environmental Part. CAS No.: or

Risk Assessment Report on 6-acetyl-1,1,2,4,4,7- hexamethyltertraline (AHTN) Environmental Part. CAS No.: or Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on 6-acetyl-1,1,2,4,4,7- hexamethyltertraline (AHTN) Environmental Part CAS No.: 1506-02-1 or 21145-77-7 EINECS No.:

More information

Data requirements for active substances and formulations and tier 1 effects. Info Session on Aquatic Guidance 6/7 November 2013

Data requirements for active substances and formulations and tier 1 effects. Info Session on Aquatic Guidance 6/7 November 2013 Data requirements for active substances and formulations and tier 1 effects assessment Dan Pickford Info Session on Aquatic Guidance 6/7 November 2013 1 Introduction to (eco) data requirements for Regulation

More information

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE)

SCIENTIFIC COMMITTEE ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (CSTEE) EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C - Public Health and Risk Assessment C7 - Risk assessment Brussels, C7/GF/csteeop/edta-env/100903 D(03) SCIENTIFIC COMMITTEE

More information

Alicia Hogan, Andrew Butler, Fiona Butler and Graeme Batley * NRA Environmental Consultants, Cairns QLD *CSIRO Land and Water, Lucas Heights NSW

Alicia Hogan, Andrew Butler, Fiona Butler and Graeme Batley * NRA Environmental Consultants, Cairns QLD *CSIRO Land and Water, Lucas Heights NSW Derivation of High Reliability Guideline Values for Cobalt in Freshwaters: Improving Water Quality Guidelines for Better Compliance Management in Mining Alicia Hogan, Andrew Butler, Fiona Butler and Graeme

More information

Water Management, Ankara, Turkey

Water Management, Ankara, Turkey Identification of River Basin Specific Pollutants and Derivation of Environmental Quality Standards under Water Framework Directive: Turkish Experience Esra Şıltu 1*, Aybala Koç Orhon 1, Sibel Mine Güçver

More information

Summary of Initial Risk Assessment Report

Summary of Initial Risk Assessment Report Summary of Initial Risk Assessment Report CAS No : 79-06-1 Acrylamide PRTR No of Japan: 2 This substance is assessed based on Guideline for Initial Risk Assessment Version 2.0 1. General Information 1.1

More information

Summary of Initial Risk Assessment Report

Summary of Initial Risk Assessment Report R0083 Summary of Initial Risk Assessment Report Formaldehyde CAS No : 50-00-0 PRTR No of Japan: 310 This substance is assessed based on Guideline for Initial Risk Assessment Version1.0 1. General Information

More information

1-METHOXYPROPAN-2-OL (PGME) Part I Environment. CAS No: EINECS No:

1-METHOXYPROPAN-2-OL (PGME) Part I Environment. CAS No: EINECS No: Institute for Health and Consumer Protection European Chemicals Bureau I-21020 Ispra (VA) Italy 1-METHOXYPROPAN-2-OL (PGME) Part I Environment CAS No: 107-98-2 EINECS No: 203-539-1 Summary Risk Assessment

More information

Summary of Initial Risk Assessment Report

Summary of Initial Risk Assessment Report R002 Summary of Initial Risk Assessment Report Acetonitrile CAS No : 75-05-8 PRTR No of Japan: 12 This substance is assessed based on Guideline for Initial Risk Assessment Version 1.0 1. General Information

More information

Letter report /2009 R. van Herwijnen. Environmental risk limits for cumene

Letter report /2009 R. van Herwijnen. Environmental risk limits for cumene Letter report 601782018/2009 R. van Herwijnen Environmental risk limits for cumene RIVM Letter report 601782018/2009 Environmental risk limits for cumene R. van Herwijnen Contact: R. van Herwijnen Expertise

More information

Water Class Use CS MS FAV CS Basis 1 1,2Bd DW, NonSalmonid 14 ng/l 85 µg/l 170 µg/l PCA Hs

Water Class Use CS MS FAV CS Basis 1 1,2Bd DW, NonSalmonid 14 ng/l 85 µg/l 170 µg/l PCA Hs AQUATIC LIFE CRITERIA AND WATER QUALITY STANDARDS Page 1 SUMMARY A. Chemical/Element: Perfluorooctanesulfonic acid (PFOS) CAS# 1763231 Dates Proposed/Promulgated / Aquatic Tox. & Human Health Site-specific

More information

Methodology for the development of wildlife criteria for the lake Erie drainage basin.

Methodology for the development of wildlife criteria for the lake Erie drainage basin. 3745-1-43 Methodology for the development of wildlife criteria for the lake Erie drainage basin. [Comment: For dates of non-regulatory government publications, publications of recognized organizations

More information

FSC STANDARD. Indicators and thresholds for the identification of highly hazardous pesticides (HHP) Forest Stewardship Council FSC-STD V1-0 EN

FSC STANDARD. Indicators and thresholds for the identification of highly hazardous pesticides (HHP) Forest Stewardship Council FSC-STD V1-0 EN Forest Stewardship Council FSC STANDARD Indicators and thresholds for the identification of highly hazardous pesticides (HHP) FSC-STD-30-001 V1-0 EN PESTICIDES Title: Document reference code: Approval

More information

Criteria for Classification and Labelling of Substances and Mixtures

Criteria for Classification and Labelling of Substances and Mixtures Criteria for Classification and Labelling of Substances and Mixtures ENVIRONMENTAL HAZARDS Jonas Falck Swedish Chemicals Agency 17 June 2009 Coverage Mainly focus on short term and long term effects on

More information

Methodology for the determination of hazardous substances for the purposes of the Groundwater Daughter Directive (2006/118/EC)

Methodology for the determination of hazardous substances for the purposes of the Groundwater Daughter Directive (2006/118/EC) Methodology for the determination of hazardous substances for the purposes of the Groundwater Daughter Issued by the Joint Agencies Groundwater Directive Advisory Group (JAGDAG) 28 June 2012 Foreword Under

More information

Summary of Initial Risk Assessment Report

Summary of Initial Risk Assessment Report Summary of Initial Risk Assessment Report Cresol CAS No : 1319-77-3 PRTR No of Japan: 67 This substance is assessed based on Guideline for Initial Risk Assessment Version 1.0 1. General Information 1.1

More information

Toxic and non-toxic disturbances PNEC estimation and validation. Tone Frost, Statoil

Toxic and non-toxic disturbances PNEC estimation and validation. Tone Frost, Statoil Toxic and nontoxic disturbances PNEC estimation and validation Tone Frost, Statoil EIF DD framework Release information 1. Hazard identification Literature information 2. Exposure Modeling (PEC) 3. Effect

More information

Risk Assessment Report on 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8,- hexamethylcyclopenta-γ-2-benzopyran (HHCB) Environmental Part

Risk Assessment Report on 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8,- hexamethylcyclopenta-γ-2-benzopyran (HHCB) Environmental Part Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on 1,3,4,6,7,8hexahydro4,6,6,7,8,8, hexamethylcyclopentaγ2benzopyran (HHCB) Environmental Part CAS No.: 1222055 EINECS

More information

OPINION ON. Perfluorooctane sulphonate (PFOS)

OPINION ON. Perfluorooctane sulphonate (PFOS) Scientific Committee on Health and Environmental Risks SCHER OPINION ON "CHEMICALS AND THE WATER FRAMEWORK DIRECTIVE: DRAFT ENVIRONMENTAL QUALITY STANDARDS" Perfluorooctane sulphonate (PFOS) SCHER adopted

More information

Environmental hazard classification and labelling. Jonas Falck Swedish Chemicals Agency

Environmental hazard classification and labelling. Jonas Falck Swedish Chemicals Agency Environmental hazard classification and labelling Jonas Falck Swedish Chemicals Agency ITP 22 September 2014 Contents Background and scope The classification scheme Criteria for env. hazard classification

More information

5-6 RINGS POLYAROMATIC HYDROCARBONS (PAH)

5-6 RINGS POLYAROMATIC HYDROCARBONS (PAH) PAH-5-6-rings EQS dossier 2011 5-6 RINGS POLYAROMATIC HYDROCARBONS (PAH) This EQS dossier was prepared by the Sub-Group on Review of the Priority Substances List (under Working Group E of the Common Implementation

More information

Evaluation of Quality Standards (EQS) and Predicted No Effect Concentrations (PNEC)

Evaluation of Quality Standards (EQS) and Predicted No Effect Concentrations (PNEC) Neptune 21./22. April 2009 Water Framework Directive and Emerging Pollutants Measures to Minimize River Contamination by WWTP Discharges Evaluation of Quality Standards (EQS) and Predicted No Effect Concentrations

More information

Common Implementation Strategy for the Water Framework Directive. Mercury and its Compounds

Common Implementation Strategy for the Water Framework Directive. Mercury and its Compounds Common Implementation Strategy for the Water Framework Directive Environmental Quality Standards (EQS) Substance Data Sheet Priority Substance No. 21 Mercury and its Compounds CAS-No. 7439-97-6 Final version

More information

Other substances or articles presenting a danger during transport, but not meeting the definitions of another class

Other substances or articles presenting a danger during transport, but not meeting the definitions of another class Genetically modified live animals shall be transported under terms and conditions of the competent authorities of the countries of origin and destination. Other substances or articles presenting a danger

More information

DECISION FRAMEWORKS AND DATA INTEGRATION. Alternatives to Animals for Ecotox Testing Committee Eco TTC Framework Scott Belanger, PhD, P&G

DECISION FRAMEWORKS AND DATA INTEGRATION. Alternatives to Animals for Ecotox Testing Committee Eco TTC Framework Scott Belanger, PhD, P&G DECISION FRAMEWORKS AND DATA INTEGRATION Alternatives to Animals for Ecotox Testing Committee Eco TTC Framework Scott Belanger, PhD, P&G Frameworks for intelligent non animal testing Framework development

More information

ANNEX 9 GUIDANCE ON HAZARDS TO THE AQUATIC ENVIRONMENT

ANNEX 9 GUIDANCE ON HAZARDS TO THE AQUATIC ENVIRONMENT ANNEX 9 GUIDANCE ON HAZARDS TO THE AQUATIC ENVIRONMENT Annex 9 GUIDANCE ON HAZARDS TO THE AQUATIC ENVIRONMENT Contents Page A9.1 Introduction... 449 A9.2 The harmonized classification scheme... 452 A9.2.1

More information

A new framework to diagnose the direct disposal of prescribed drugs in wastewater a

A new framework to diagnose the direct disposal of prescribed drugs in wastewater a 1 2 3 4 5 6 7 Supporting information A new framework to diagnose the direct disposal of prescribed drugs in wastewater a case study of the antidepressant fluoxetine Bruce Petrie a, Jane Youdan b, Ruth

More information

Safety Data Sheet. CPA538/12/A/TT INTERPRIME 538??????? Version 1 Revision Date 10/21/13

Safety Data Sheet. CPA538/12/A/TT INTERPRIME 538??????? Version 1 Revision Date 10/21/13 International Paint Taiwan Safety Data Sheet CPA538/12/A/TT INTERPRIME 538??????? Version 1 Revision Date 10/21/13 1. Product and company identification 1.1. Product identifier INTERPRIME 538??????? Product

More information

Draft agreed by Environmental Risk Assessment Working Party (ERAWP) 31 May Adopted by CVMP for release for consultation 12 July 2012

Draft agreed by Environmental Risk Assessment Working Party (ERAWP) 31 May Adopted by CVMP for release for consultation 12 July 2012 10 September 2015 EMA/CVMP/ERA/52740/2012 Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very

More information

Nations, All rights reserved PART 4 ENVIRONMENTAL HAZARDS

Nations, All rights reserved PART 4 ENVIRONMENTAL HAZARDS PART 4 ENVIRONMENTAL HAZARDS CHAPTER 4.1 HAZARDOUS TO THE AQUATIC ENVIRONMENT 4.1.1 Definitions and general considerations 4.1.1.1 Definitions Acute aquatic toxicity means the intrinsic property of a

More information

Safety Summary. Ammophos

Safety Summary. Ammophos EuroChem-BMU Chemical Site Belorechensk Krasnodar Territory, 352636, Russia Safety Summary This Product Safety Summary is intended to provide a brief overview of the information on the risk assessment

More information

Please find below the Commission Communication and the Commission Recommendation for the substance

Please find below the Commission Communication and the Commission Recommendation for the substance Please find below the Commission Communication and the Commission Recommendation for the substance 2,2,6,6 -TETRABROMO-4,4 -ISOPROPYLIDENE DIPHENOL (TETRABROMOBISPHENOL-A) CAS Number: 79-94-7 EINECS Number:

More information

ANNEX 9 GUIDANCE ON HAZARDS TO THE AQUATIC ENVIRONMENT

ANNEX 9 GUIDANCE ON HAZARDS TO THE AQUATIC ENVIRONMENT ANNEX 9 GUIDANCE ON HAZARDS TO THE AQUATIC ENVIRONMENT Annex 9 GUIDANCE ON HAZARDS TO THE AQUATIC ENVIRONMENT CONTENTS A9.1 Introduction... 443 A9.2 The harmonized classification scheme... 446 A9.2.1

More information

(Question N EFSA-Q ) adopted on 14 December 2005

(Question N EFSA-Q ) adopted on 14 December 2005 Opinion of the Scientific Panel on Plant health, Plant protection products and their Residues on a request from EFSA related to the assessment of the acute and chronic risk to aquatic organisms with regard

More information

Safety Data Sheet. EAS198 INTERZONE 954 YELLOW PART A Version Number 2 Revision Date 04/24/18

Safety Data Sheet. EAS198 INTERZONE 954 YELLOW PART A Version Number 2 Revision Date 04/24/18 International Paint Singapore Pte Ltd Safety Data Sheet EAS198 INTERZONE 954 YELLOW PART A Version Number 2 Revision Date 04/24/18 1. Product and company identification 1.1. Product identifier INTERZONE

More information

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. Safety of the Food chain Chemicals, contaminants, pesticides

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. Safety of the Food chain Chemicals, contaminants, pesticides EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Safety of the Food chain Chemicals, contaminants, pesticides Brussels, 25.09.2012 rev. 3 DG SANCO Working Document on "Evidence Needed to Identify

More information

Understanding Human and Environmental Hazards: An activity for undergraduate chemistry students

Understanding Human and Environmental Hazards: An activity for undergraduate chemistry students Understanding Human and Environmental Hazards: An activity for undergraduate chemistry students An activity prepared by Beyond Benign as part of the Green Chemistry in Higher Education program: A workshop

More information

European Union Risk Assessment Report

European Union Risk Assessment Report European Union Risk Assessment Report CHLOROFORM CAS No: 67-66-3 EINECS No: 200-663-8 SUMMARY RISK ASSESSMENT Environment rapporteur france S047_0711_env.doc LEGAL NOTICE Neither the European Commission

More information

2 EXISTING EVALUATIONS AND REGULATORY INFORMATION

2 EXISTING EVALUATIONS AND REGULATORY INFORMATION Fluoranthene EQS dossier 11 FLUORANTHENE This EQS dossier was prepared by the Sub-Group on Review of the Priority Substances List (under Working Group E of the Common Implementation Strategy for the Water

More information

Safety Data Sheet. BEA354 INTERSMOOTH 360 SPC BROWN Version Number 1 Revision Date 07/05/13. For professional use only.

Safety Data Sheet. BEA354 INTERSMOOTH 360 SPC BROWN Version Number 1 Revision Date 07/05/13. For professional use only. International Paint Singapore Pte Ltd Safety Data Sheet BEA354 INTERSMOOTH 360 SPC BROWN Version Number 1 Revision Date 07/05/13 1. Product and company identification 1.1. Product identifier INTERSMOOTH

More information

2-Ethoxyethyl acetate

2-Ethoxyethyl acetate 2-Ethoxyethyl acetate CAS No: 111-15-9 EINECS No: 203-839-2 SUMMARY RISK ASSESSMENT Final report, 2008 Germany FINAL APPROVED VERSION Rapporteur for the risk assessment of 2-Ethoxyethyl acetate is Germany

More information

2.9.3 Environmentally hazardous substances (aquatic environment)

2.9.3 Environmentally hazardous substances (aquatic environment) Ammonium nitrate based fertilizers 2071 AMMONIUM NITRATE BASED FERTILIZERS Solid ammonium nitrate based fertilizers shall be classified in accordance with the procedure as set out in the Manual of Tests

More information

: PAD LOCK. SECTION 1: Identification. SECTION 2: Hazard(s) identification Identification Recommended use and restrictions on use

: PAD LOCK. SECTION 1: Identification. SECTION 2: Hazard(s) identification Identification Recommended use and restrictions on use SECTION 1: Identification 1.1. Identification Product form Product name PAD LOCK Date of issue: 3/14/2018 Version: 6 : Mixture 1.2. Recommended use and restrictions on use Use of the substance/mixture

More information

: P&G PROFESSIONAL FLASH Antibacterial Degreaser Spray

: P&G PROFESSIONAL FLASH Antibacterial Degreaser Spray P&G PROFESSIONAL FLASH Antibacterial Degreaser Spray Date of issue: 21/11/2013 Revision date: : Version: 1.0 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product

More information

REACH challenge: can ECHA deal with it? ecopa 29 November Brussel. Dr. Erwin Annys

REACH challenge: can ECHA deal with it? ecopa 29 November Brussel. Dr. Erwin Annys REACH challenge: can ECHA deal with it? ecopa 29 November Brussel Dr. Erwin Annys 1 REACH Registration Evaluation Authorisation and Restriction of Chemical substances 2 Registration Pre-registration >1000

More information

Environmental Risk Assessment

Environmental Risk Assessment Environmental Risk Assessment Catriona Cooke Director, Ecotoxicology and Regulatory Services Smithers Viscient www.smithersviscient.com catriona.cooke@smithers.com Regulatory Intelligence Environmental

More information

Felodipin Teva. Teva Depottablett 5 mg (ljusrosa, rund, bikonvex, filmdragerad) kalciumantagonist/dihydropyridinderivat. Aktiv substans: Felodipin

Felodipin Teva. Teva Depottablett 5 mg (ljusrosa, rund, bikonvex, filmdragerad) kalciumantagonist/dihydropyridinderivat. Aktiv substans: Felodipin Felodipin Teva Teva Depottablett 5 mg (ljusrosa, rund, bikonvex, filmdragerad) kalciumantagonist/dihydropyridinderivat Aktiv substans: Felodipin ATC-kod: C08CA02 Företaget omfattas av Läkemedelsförsäkringen

More information

Environmental Risk Limits for Zinc

Environmental Risk Limits for Zinc RIVM letter report 11235/2007 Environmental Risk Limits for Zinc C.W.M. Bodar This investigation has been performed for the account Directorate-General for Environmental Protection, Directorate for Chemicals,

More information

Letter report /2008 C.W.M. Bodar. Environmental risk limits for acrolein

Letter report /2008 C.W.M. Bodar. Environmental risk limits for acrolein Letter report 601782010/2008 C.W.M. Bodar Environmental risk limits for acrolein RIVM letter report 601782010/2008 Environmental risk limits for acrolein C.W.M. Bodar Contact: Dr. C.W.M. Bodar Expertise

More information

Safety Data Sheet. tha131 INTERLINE 925 GREEN PART B Version Number 1 Revision Date 11/28/13. For professional use only.

Safety Data Sheet. tha131 INTERLINE 925 GREEN PART B Version Number 1 Revision Date 11/28/13. For professional use only. PT. International Paint Indonesia Safety Data Sheet tha131 INTERLINE 925 GREEN PART B Version Number 1 Revision Date 11/28/13 1. Product and company identification 1.1. Product identifier INTERLINE 925

More information

Official Journal of the European Communities. (Acts whose publication is obligatory)

Official Journal of the European Communities. (Acts whose publication is obligatory) L 331/1 I (Acts whose publication is obligatory) DECISION No 2455/2001/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 November 2001 establishing the list of priority substances in the field of

More information

Safety Data Sheet. EVZ912/20LT INTERGARD 475HS???????????? Version 1 Revision Date 10/21/13

Safety Data Sheet. EVZ912/20LT INTERGARD 475HS???????????? Version 1 Revision Date 10/21/13 International Paint Taiwan Safety Data Sheet EVZ912/20LT INTERGARD 475HS???????????? Version 1 Revision Date 10/21/13 1. Product and company identification 1.1. Product identifier INTERGARD 475HS????????????

More information

ANNEX 9 GUIDANCE ON HAZARDS TO THE AQUATIC ENVIRONMENT

ANNEX 9 GUIDANCE ON HAZARDS TO THE AQUATIC ENVIRONMENT ANNEX 9 GUIDANCE ON HAZARDS TO THE AQUATIC ENVIRONMENT Annex 9 GUIDANCE ON HAZARDS TO THE AQUATIC ENVIRONMENT CONTENTS A9.1 Introduction... 471 A9.2 The harmonized classification scheme... 474 A9.2.1

More information

Safety Data Sheet According to 1907/2006/EC (REACH) and its amendments

Safety Data Sheet According to 1907/2006/EC (REACH) and its amendments SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Product name: 1.2. Relevant identified uses of the substance or mixture and uses advised against

More information

PROPAN-1-OL. Part I Environment. CAS No: EINECS No:

PROPAN-1-OL. Part I Environment. CAS No: EINECS No: Institute for Health and Consumer Protection Toxicology and Chemical Substance (TCS) European Chemicals Bureau I-21027 Ispra (VA) Italy PROPAN-1-OL Part I Environment CAS No: 71-23-8 EINECS No: 200-746-9

More information

The guidelines to protect wildlife, freshwater life, marine life, livestock and source human drinking water are summarized in Table 1.

The guidelines to protect wildlife, freshwater life, marine life, livestock and source human drinking water are summarized in Table 1. Water Quality Ambient Water Quality Guidelines for Chlorate Environmental Quality Branch Ministry of Environment Prepared pursuant to Section 2(e) of the Environment Management Act Approved: Assistant

More information

Special request, Advice May Review of environmental assessment criteria or equivalents

Special request, Advice May Review of environmental assessment criteria or equivalents 1.5.5.3 Special request, Advice May 2012 ECOREGION SUBJECT General advice Review of environmental assessment criteria or equivalents Advice summary ICES agrees that a pragmatic way forward is needed in

More information

Republic of Turkey Ministry of Forestry and Water Affairs DG Water Management Department of Water Quality

Republic of Turkey Ministry of Forestry and Water Affairs DG Water Management Department of Water Quality Identification of River Basin Specific Pollutants and Derivation of Environmental Quality Standards under Water Framework Directive: Turkish Experience Republic of Turkey Ministry of Forestry and Water

More information

Safety Data Sheet. HXA028/5LT INTERLAC 648?????? Version 1 Revision Date 10/21/13

Safety Data Sheet. HXA028/5LT INTERLAC 648?????? Version 1 Revision Date 10/21/13 International Paint Taiwan Safety Data Sheet HXA028/5LT INTERLAC 648?????? Version 1 Revision Date 10/21/13 1. Product and company identification 1.1. Product identifier INTERLAC 648?????? Product Code

More information

Euro Chlor Risk Assessment for the Marine Environment OSPARCOM Region - North Sea. Hexachlorobenzene

Euro Chlor Risk Assessment for the Marine Environment OSPARCOM Region - North Sea. Hexachlorobenzene Euro Chlor Risk Assessment for the Marine Environment OSPARCOM Region - North Sea January 2002 EURO CHLOR RISK ASSESSMENT FOR THE MARINE ENVIRONMENT HEXACHLOROBENZENE (HCB) January 2002 OSPARCOM Region

More information

Safety Data Sheet. EVC243 INTERGARD 475HS ORANGE PART A Version Number 1 Revision Date 11/27/13. For professional use only.

Safety Data Sheet. EVC243 INTERGARD 475HS ORANGE PART A Version Number 1 Revision Date 11/27/13. For professional use only. PT. International Paint Indonesia Safety Data Sheet EVC243 INTERGARD 475HS ORANGE PART A Version Number 1 Revision Date 11/27/13 1. Product and company identification 1.1. Product identifier INTERGARD

More information

Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO First edition

Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO First edition INTERNATIONAL STANDARD ISO 13073-1 First edition 2012-08-01 Ships and marine technology Risk assessment on anti-fouling systems on ships Part 1: Marine environmental risk assessment method of biocidally

More information

Ecotoxicology of agrochemicals. U n i v e r s i t y o f G i r o n a

Ecotoxicology of agrochemicals. U n i v e r s i t y o f G i r o n a Ecotoxicology of agrochemicals U n i v e r s i t y o f G i r o n a Program 1. Introduction 2. Agrochemicals typology and activity 3. Environmental behavior of agrochemicals 4. Bioavailability and biotransformation

More information

Risk Assessment Report on p-tert-buthylphenol. Environmental Part. CAS No.: EINECS No.:

Risk Assessment Report on p-tert-buthylphenol. Environmental Part. CAS No.: EINECS No.: Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on p-tert-buthylphenol Environmental Part CAS No.: 98-54-4 EINECS No.: 202-679-0 The SCHER adopted this opinion at its

More information

THE ROLE OF ECOTOXICOLOGY FOR MONITORING ECOSYSTEM HEALTH

THE ROLE OF ECOTOXICOLOGY FOR MONITORING ECOSYSTEM HEALTH ECOTOXICOLOGY AND MONITORING ECOSYSTEM HEALTH 91 THE ROLE OF ECOTOXICOLOGY FOR MONITORING ECOSYSTEM HEALTH ERIC VINDIMIAN (Dr E. Vindimian, Institut national de I 'environnement industriel et des risques

More information

Guidance on information requirements and chemical safety assessment

Guidance on information requirements and chemical safety assessment Guidance on information requirements and chemical safety assessment Part C: PBT and vpvb Assessment Version.X XX 0X LEGAL NOTICE This document contains guidance on REACH explaining the REACH obligations

More information

The Water Framework Directive and its Relevance to Plant Protection Products. Mark Crane

The Water Framework Directive and its Relevance to Plant Protection Products. Mark Crane The Water Framework Directive and its Relevance to Plant Protection Products Mark Crane Overview What does the WFD require? Which PPPs are covered by the WFD? How are substances selected & prioritised

More information

Safety Data Sheet. EMC244 INTERGARD 410 ORANGE PART A Version Number 2 Revision Date 04/26/18

Safety Data Sheet. EMC244 INTERGARD 410 ORANGE PART A Version Number 2 Revision Date 04/26/18 International Paint Singapore Pte Ltd Safety Data Sheet EMC244 INTERGARD 410 ORANGE PART A Version Number 2 Revision Date 04/26/18 1. Product and company identification 1.1. Product identifier INTERGARD

More information

Environmental Safety Assessment of New Animal Drugs

Environmental Safety Assessment of New Animal Drugs Environmental Safety Assessment of New Animal Drugs Wesley Hunter, Ph.D. U.S. Food and Drug Administration Center for Veterinary Medicine Environmental Safety Team Outline Legal mandates and implementation

More information

SECTION 1: Identification of the substance/mixture and of the company/undertaking. SECTION 2: Hazards identification

SECTION 1: Identification of the substance/mixture and of the company/undertaking. SECTION 2: Hazards identification Tropical UltraClean Asphalt & Tar Remover SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product form Product name : Mixture : Tropical UltraClean

More information

Substance Name: Benzo[k]fluoranthene. EC Number: CAS Number: MEMBER STATE COMMITTEE SUPPORT DOCUMENT FOR IDENTIFICATION OF

Substance Name: Benzo[k]fluoranthene. EC Number: CAS Number: MEMBER STATE COMMITTEE SUPPORT DOCUMENT FOR IDENTIFICATION OF Substance Name: Benzo[k]fluoranthene EC Number: 205-916-6 CAS Number: 207-08-9 MEMBER STATE COMMITTEE SUPPORT DOCUMENT FOR IDENTIFICATION OF BENZO[K]FLUORANTHENE AS A SUBSTANCE OF VERY HIGH CONCERN BECAUSE

More information

PFOS, Perfluorooctane Sulfonate

PFOS, Perfluorooctane Sulfonate PFOS, Perfluorooctane Sulfonate For nomination to UN- ECE LRTAP Protocol on POPs Niklas Johansson, Swedish EPA PFOS, Perfluorooctane Sulfonate as its potassium salt From the Original PFOS dossier Criterion

More information

Mixture Hazard Assessment Methodology

Mixture Hazard Assessment Methodology Mixture Hazard Assessment Methodology March 2018 Written in collaboration with ToxServices LLC Copyright 2017 Cradle to Cradle Products Innovation Institute No part of this publication is to be reproduced

More information

A Probabilistic Fate and Effects Model for Pharmaceuticals and Personal Care Products

A Probabilistic Fate and Effects Model for Pharmaceuticals and Personal Care Products A Probabilistic Fate and Effects Model for Pharmaceuticals and Personal Care Products Miranda Henning, Jennifer Lyndall, Michael J. Bock, Timothy Barber, Darrel Lauren Water Dependencies in New England:

More information

Guidance on Information Requirements and Chemical Safety Assessment

Guidance on Information Requirements and Chemical Safety Assessment G U I D A N C E Guidance on Information Requirements and Chemical Safety Assessment Part C: PBT/vPvB assessment Version 3.0 June 2017 2 Part C: PBT/vPvB Assessment Version 3.0 June 2017 Legal notice This

More information

Safety Data Sheet According to Regulation (EC) No 1907/2006

Safety Data Sheet According to Regulation (EC) No 1907/2006 Safety Data Sheet According to Regulation (EC) No 1907/2006 Revision: 2012-09-11 Version 07 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Trade

More information

Floor Terrazzo W 330

Floor Terrazzo W 330 Floor Terrazzo W 330 - Version 3 Page 1 of 12 SAFETY DATA SHEET Floor Terrazzo W 330 The safety data sheet is in accordance with Commission Regulation (EU) 2015/830 of 28 May 2015 amending Regulation (EC)

More information

Bioaccumulation Of Metal Substances by Aquatic Organisms Part 1

Bioaccumulation Of Metal Substances by Aquatic Organisms Part 1 Bioaccumulation Of Metal Substances by Aquatic Organisms Part 1 Bill Adams OECD Meeting, Paris September 7-8, 2011 Bioaccumulation A Fish Story Presentation Overview Bioaccumulation in aquatic organisms

More information

SAFETY DATA SHEET. In accordance with REACH Regulation EC No.1907/2006. Section 1. Identification of the substance or the mixture and of the supplier

SAFETY DATA SHEET. In accordance with REACH Regulation EC No.1907/2006. Section 1. Identification of the substance or the mixture and of the supplier Page 1 ( 8 ) Section 1. Identification of the substance or the mixture and of the supplier 1.1 Product Identifier Product identifier: (E)-2-benzylideneoctanal; CAS: 165184-98-5; REACH REG: 01-2119533092-50-0004

More information

MANUAL FOR INVESTIGATION OF HPV CHEMICALS

MANUAL FOR INVESTIGATION OF HPV CHEMICALS MANUAL FOR INVESTIGATION OF HPV CHEMICALS CHAPTER 1: PROCEDURES, INCLUDING THE USE OF THE ELECTRONIC DISCUSSION GROUPS AND THE ON-LINE OECD EXISTING CHEMICALS DATABASE ANNEX 3 : SYNERGIES BETWEEN THE CEPA

More information

Methods for the Risk Assessment of Priority Assessment Chemical Substances

Methods for the Risk Assessment of Priority Assessment Chemical Substances Methods for the Risk Assessment of Priority Assessment Chemical Substances January 2012 Table of Contents I. Introduction... 1 1. Background...1 2. Objectives of the risk assessment...1 II. Basic premises

More information