CHEMICAL SAFETY REPORT. Substance Name: Glucose EC Number: CAS Number: Registrant's Identity: Example Company 1

Transcription

1 CHEMICAL SAFETY REPORT Substance Name: Glucose EC Number: CAS Number: Registrant's Identity: Example Company 1

2 Table of Contents Part A SUMMARY OF RISK MANAGEMENT MEASURES DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED... 4 Part B IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES Name and other identifiers of the substance Composition of the substance Physicochemical properties MANUFACTURE AND USES Manufacture Identified uses CLASSIFICATION AND LABELLING Classification and labelling according to CLP / GHS ENVIRONMENTAL FATE PROPERTIES Degradation Abiotic degradation Hydrolysis Phototransformation/photolysis Phototransformation in air Phototransformation in water Phototransformation in soil Biodegradation Biodegradation in water Screening tests Simulation tests (water and sediments) Summary and discussion of biodegradation in water and sediment Biodegradation in soil Summary and discussion of degradation Environmental distribution Adsorption/desorption Volatilisation Distribution modelling Summary and discussion of environmental distribution Bioaccumulation Aquatic bioaccumulation Terrestrial bioaccumulation Summary and discussion of bioaccumulation Secondary poisoning HUMAN HEALTH HAZARD ASSESSMENT Toxicokinetics (absorption, metabolism, distribution and elimination) Non-human information Human information Summary and discussion of toxicokinetics Acute toxicity Non-human information Acute toxicity: oral Acute toxicity: inhalation Acute toxicity: dermal Acute toxicity: other routes Human information Summary and discussion of acute toxicity Irritation Skin /04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report ii

3 Non-human information Human information Eye Non-human information Human information Respiratory tract Non-human information Human information Summary and discussion of irritation Corrosivity Non-human information Human information Summary and discussion of corrosion Sensitisation Skin Non-human information Human information Respiratory system Non-human information Human information Summary and discussion of sensitisation Repeated dose toxicity Non-human information Repeated dose toxicity: oral Repeated dose toxicity: inhalation Repeated dose toxicity: dermal Repeated dose toxicity: other routes Human information Summary and discussion of repeated dose toxicity Mutagenicity Non-human information In vitro data In vivo data Human information Summary and discussion of mutagenicity Carcinogenicity Non-human information Carcinogenicity: oral Carcinogenicity: inhalation Carcinogenicity: dermal Carcinogenicity: other routes Human information Summary and discussion of carcinogenicity Toxicity for reproduction Effects on fertility Non-human information Human information Developmental toxicity Non-human information Human information Summary and discussion of reproductive toxicity Other effects Non-human information Neurotoxicity Immunotoxicity Specific investigations: other studies Human information Summary and discussion of other effects /04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report iii

4 5.11. Derivation of DNEL(s) and other hazard conclusions Overview of typical dose descriptors for all endpoints Selection of the DNEL(s) or other hazard conclusions for critical health effects HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES Explosivity Flammability Oxidising potential ENVIRONMENTAL HAZARD ASSESSMENT Aquatic compartment (including sediment) Fish Short-term toxicity to fish Long-term toxicity to fish Aquatic invertebrates Short-term toxicity to aquatic invertebrates Long-term toxicity to aquatic invertebrates Algae and aquatic plants Sediment organisms Other aquatic organisms Terrestrial compartment Toxicity to soil macro-organisms Toxicity to terrestrial plants Toxicity to soil micro-organisms Toxicity to other terrestrial organisms Microbiological activity in sewage treatment systems Non compartment specific effects relevant for the food chain (secondary poisoning) Toxicity to birds Toxicity to mammals PNEC derivation and other hazard conclusions PBT AND vpvb ASSESSMENT Assessment of PBT/vPvB Properties PBT/vPvB criteria and justification Assessed substance: not specified Persistence assessment Bioaccumulation assessment Toxicity assessment Summary and overall conclusions on PBT or vpvb properties Emission characterisation EXPOSURE ASSESSMENT (and related risk characterisation) RISK CHARACTERISATION RELATED TO COMBINED EXPOSURE Annexes Annex: s Annex: Information on Test Material /04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report iv

5 List of Tables 1.1. Substance identity Constituents (Standard composition) Constituents (Test composition) Physicochemical properties Quantities (in tonnes/year) Formulation Uses at industrial sites Uses by professional workers Consumer uses Article service life Classification and labelling according to CLP / GHS for physicochemical properties Classification and labelling according to CLP / GHS for health hazards Classification and labelling according to CLP / GHS for the environment Studies on hydrolysis Screening tests for biodegradation in water Studies on adsorption/desorption Studies on absorption, metabolism, distribution and elimination Studies on acute toxicity after oral administration Studies on acute toxicity after inhalation exposure Studies on acute toxicity after dermal administration Studies on skin irritation Studies on eye irritation Studies on skin irritation related to corrosivity Studies on skin sensitisation Studies on repeated dose toxicity after oral administration Studies on repeated dose toxicity after inhalation exposure Studies on repeated dose toxicity after dermal administration The results of in vitro genotoxicity studies are summarised in the following table: Studies on fertility Hazard conclusions for workers Hazard conclusions for the general population Information on flammability Information on oxidising potential Short-term effects on aquatic invertebrates Effects on algae and aquatic plants Effects on micro-organisms Hazard assessment conclusion for the environment /04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report v

6 Part A

7 1. SUMMARY OF RISK MANAGEMENT MEASURES 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 2

8 2. DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 3

9 3. DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 4

10 Part B

11 1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES 1.1. Name and other identifiers of the substance The substance Glucose is a mono-constituent substance (organic) having the following characteristics and physical chemical properties (see the IUCLID dataset for further details). The following public name is used: Sugar Table 1.1. Substance identity EC number: EC name: glucose CAS number (EC inventory): CAS number: Molecular formula: C6H12O6 Molecular weight range: ca.180 Structural formula: 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 6

12 Figure 1.1. glucose-structure.png 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 7

13 Other identifiers: trade name FCSDS 1.2. Composition of the substance Overall information on composition Composition Standard composition (legal entity composition of the substance) Test composition (boundary composition of the substance) Related composition(s) Name: Standard composition State/form: Degree of purity: >=99 - <=100 % (w/w) Description: Table 1.2. Constituents (Standard composition) Constituent Typical concentration Concentration range Remarks Glucose EC no.: Name: Test composition ca.99.5 % (w/w) State/form: Degree of purity: >=98 - <=100 % (w/w) Description: Table 1.3. Constituents (Test composition) >=99 - <=100 % (w/w) Constituent Typical concentration Concentration range Remarks Glucose EC no.: ca.99 % (w/w) 1.3. Physicochemical properties >=98 - <=100 % (w/w) Table 1.4. Physicochemical properties Property Description of key information Value used for CSA / Data waiving Information requirement: Boiling point Reason: study scientifically not necessary / other information available Justification: the study does not need to be conducted because the substance is a solid which decomposes before boiling [study scientifically not necessary / other information available] Information requirement: Granulometry Reason: study scientifically not necessary / other information available Justification: the study does not need to be conducted because the substance is marketed or used in a non solid or granular form [study scientifically not necessary / other information available] Information requirement: Flash point Reason: study technically not feasible Justification: the study does not need to be conducted because the flash point is only relevant to liquids and low melting point solids [study technically not feasible] Information requirement: Self-ignition temperature 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 8

14 Reason: study scientifically not necessary / other information available Justification: the study does not need to be conducted because the substance is a solid having a melting point <= 160 C [study scientifically not necessary / other information available] Information requirement: Explosive properties Reason: study scientifically not necessary / other information available Justification: the study does not need to be conducted because there are no chemical groups present in the molecule which are associated with explosive properties [study scientifically not necessary / other information available] 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 9

15 2. MANUFACTURE AND USES Table 2.1. Quantities (in tonnes/year) Year Tonnages (tonnes per year) 2017 Manufactured: 2 Imported: 2 Directly exported: Manufactured: 2 Imported: 2 Directly exported: 2015 Manufactured: 2 Imported: 2 Directly exported: 2.1. Manufacture No information available on manufacture 2.2. Identified uses Table 2.2. Formulation Formulation F- Formulation of paint Related composition (see section 1.x): Further description of the use: Contributing activity/technique for the environment : - (ERC2) Contributing activity/technique for the workers : - (PROC 14) Product Category formulated: Technical function of the substance: solvent Substance supplied to that use: Related assessment: Table 2.3. Uses at industrial sites IW- Uses at industrial sites Industrial Related composition (see section 1.x): Further description of the use: Contributing activity/technique for the environment : - (ERC6b) Contributing activity/technique for the workers : - (PROC 14) Product Category used: Sector of end use: SU 11: Manufacture of rubber products Technical function of the substance: intermediate (precursor) Substance supplied to that use: Subsequent service life relevant for that use: yes Link to the subsequent service life: IW- Industrial 2 Related composition (see section 1.x): 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 10

16 Further description of the use: Contributing activity/technique for the environment : - (ERC6b) Contributing activity/technique for the workers : - (PROC 11) Product Category used: Sector of end use: SU 8: Manufacture of bulk, large scale chemicals (including petroleum products) Technical function of the substance: impregnation agent Substance supplied to that use: Subsequent service life relevant for that use: yes Link to the subsequent service life: Table 2.4. Uses by professional workers PW- Uses by professional workers Professional Related composition (see section 1.x): Further description of the use: Contributing activity/technique for the environment : - (ERC8b) Contributing activity/technique for the workers : - (PROC 15) Product Category used: Sector of end use: Technical function of the substance: energy releasers (explosives, motive propellant) Subsequent service life relevant for that use: no Link to the subsequent service life: Table 2.5. Consumer uses Consumer uses C- Consumption Related composition (see section 1.x): Further description of the use: Contributing activity/technique for the environment: - (ERC8f) Contributing activity/technique for consumers: - - Product category (PC): PC 18 Technical function of the substance: test Subsequent service life relevant for that use: yes Link to the subsequent service life: Table 2.6. Article service life SL- Article service life Service life Related composition (see section 1.x): Further description of the use: xxx Article used by: workers Substance intended to be released from article: Article category related to subsequent service life (AC): AC 13: Plastic articles Contributing activity/technique for the environment: - (ERC11a) Contributing activity/technique for consumers: 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 11

17 - - Article Category (AC): AC 13 Contributing activity/technique for the workers: Technical function of the substance: xxx 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 12

18 3. CLASSIFICATION AND LABELLING 3.1. Classification and labelling according to CLP / GHS Substance: Glucose Implementation: Related composition: Standard composition The substance is not classified The substance is classified as follows: Table 3.1. Classification and labelling according to CLP / GHS for physicochemical properties Hazard class Hazard category Hazard statement Reason for no classification Explosives: Desensitised explosives: Flammable gases and chemically unstable gases: Flammable aerosols: Oxidising gases: Gases under pressure: Flammable liquids: Flammable solids: Self-reactive substances and mixtures: Pyrophoric liquids: Pyrophoric solids: Self-heating substances and mixtures: Substances and mixtures which in contact with water emit flammable gases: Oxidising liquids: Oxidising solids: Organic peroxides: Corrosive to metals: Table 3.2. Classification and labelling according to CLP / GHS for health hazards inconclusive inconclusive Hazard class Hazard category Hazard statement Reason for no classification Acute toxicity - oral: Acute toxicity - dermal: 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 13

19 Acute toxicity - inhalation: Skin corrosion / irritation: Serious damage / eye irritation: Respiratory sensitisation: Skin sensitisation: Aspiration hazard: Reproductive Toxicity: Reproductive Toxicity: Effects on or via lactation: Germ cell mutagenicity: Carcinogenicity: Specific target organ toxicity single exposure: Specific target organ toxicity repeated exposure: Affected organs: Route of exposure: Affected organs: Route of exposure: inconclusive Table 3.3. Classification and labelling according to CLP / GHS for the environment Hazard class Hazard category Hazard statement Reason for no classification Hazards to the aquatic environment (acute/shortterm): Hazards to the aquatic environment (chronic/ long-term): M-Factor acute: M-Factor chronic: Hazardous to the ozone layer: Signal word: No signal word inconclusive inconclusive inconclusive 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 14

20 4. ENVIRONMENTAL FATE PROPERTIES General discussion of environmental fate and pathways: 4.1. Degradation Abiotic degradation Hydrolysis The studies on hydrolysis are summarised in the following table: Table 4.1. Studies on hydrolysis Method Results Remarks OECD Guideline 111 (Hydrolysis as a Function of ph) Half-life (DT50): 789 d Rate constant: 78 s-1; Recovery (in %): Transformation products: no 1 (reliable without restriction) Phototransformation/photolysis Phototransformation in air Phototransformation in water Phototransformation in soil Biodegradation Biodegradation in water Screening tests The studies on biodegradation in water (screening tests) are summarised in the following table: Table 4.2. Screening tests for biodegradation in water Method Results Remarks biodegradation in water: ready biodegradability: % Degradation of test substance: 2 (reliable with restrictions) 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 15

21 activated sludge, adapted equivalent or similar to OECD Guideline 301 A (old version) (Ready Biodegradabiltiy: Modified AFNOR Test) 2 after 2d (% degradation (DOC removal)) Simulation tests (water and sediments) Summary and discussion of biodegradation in water and sediment (screening testing) (simulation testing) Biodegradation in soil Summary and discussion of degradation Abiotic degradation Biotic degradation 4.2. Environmental distribution Adsorption/desorption The studies on adsorption/desorption are summarised in the following table: Table 4.3. Studies on adsorption/desorption Method Results Remarks adsorption / desorption: screening OECD Guideline 106 (Adsorption - Desorption Using a Batch Equilibrium Method) Adsorption coefficient: Koc: >10 - <10.5 L/kg Partition coefficients: Mass balance (in %) at end of adsorption phase: Mass balance (in %) at end of desorption phase: Transformation products: 2 (reliable with restrictions) Volatilisation 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 16

22 Distribution modelling Summary and discussion of environmental distribution 4.3. Bioaccumulation Aquatic bioaccumulation Terrestrial bioaccumulation Summary and discussion of bioaccumulation Aquatic bioaccumulation Terrestrial bioaccumulation 4.4. Secondary poisoning Based on the available information, there is no indication of a bioaccumulation potential and, hence, secondary poisoning is not considered relevant (see CSR chapter 7.6 "PNEC derivation and other hazard conclusions)"). 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 17

23 5. HUMAN HEALTH HAZARD ASSESSMENT 5.1. Toxicokinetics (absorption, metabolism, distribution and elimination) Non-human information The results of studies on absorption, metabolism, distribution and elimination are summarised in the following table: Table 5.1. Studies on absorption, metabolism, distribution and elimination Method Results Remarks basic toxicokinetics [deactivated phrase] mouse (Balb/c [mouse]) male/female oral: capsule Exposure regime: Doses/conc.: 20mg/kg bw/day (nominal) according to OECD Guideline 417 (Toxicokinetics) Human information Main ADME results: Toxicokinetic parameters: Absorption: Distribution: Excretion: Metabolites identified: Details on metabolites: Summary and discussion of toxicokinetics 5.2. Acute toxicity Non-human information Acute toxicity: oral 2 (reliable with restrictions) The results of studies on acute toxicity after oral administration are summarised in the following table: Table 5.2. Studies on acute toxicity after oral administration Method Results Remarks OECD Guideline 401 (Acute Oral Toxicity) [before 2002] LD50: 100 mg/kg bw 1 (reliable without restriction) 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 18

24 Acute toxicity: inhalation The results of studies on acute toxicity after inhalation exposure are summarised in the following table: Table 5.3. Studies on acute toxicity after inhalation exposure Method Results Remarks OECD Guideline 403 (Acute Inhalation Toxicity) Acute toxicity: dermal LC50: 200 mg/m³ air (analytical) 1 (reliable without restriction) The results of studies on acute toxicity after dermal administration are summarised in the following table: Table 5.4. Studies on acute toxicity after dermal administration Method Results Remarks Coverage: Vehicle: OECD Guideline 402 (Acute Dermal Toxicity) Acute toxicity: other routes Human information LD0: >100 mg/kg bw Summary and discussion of acute toxicity 5.3. Irritation Skin Non-human information 2 (reliable with restrictions) 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 19

25 The results of studies on skin irritation are summarised in the following table: Table 5.5. Studies on skin irritation Method Results Remarks guinea pig [other species] Coverage: Vehicle: equivalent or similar to OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion) primary dermal irritation index (PDII) 4-5 of max. 5 (Time point: 4) Reversibility: fully reversible Studies with results indicating corrosivity to the skin are summarised in section 5.4 Corrosivity Human information Eye Non-human information The results of studies on eye irritation are summarised in the following table: Table 5.6. Studies on eye irritation Method Results Remarks in vitro study Vehicle: OECD Guideline 405 (Acute Eye Irritation / Corrosion) hamster Vehicle: not specified according to EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion) in vitro irritation score value ca.25 maximum mean total score (MMTS) (animal #1) 4-5 of max. 5 (Time point: 2) fully reversible 1 (reliable without restriction) 1 (reliable without restriction) 2 (reliable with restrictions) 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 20

26 Human information Respiratory tract Non-human information No relevant information available Human information Summary and discussion of irritation 5.4. Corrosivity Non-human information The results of studies on skin irritation related to corrosivity are summarised in the following table: Table 5.7. Studies on skin irritation related to corrosivity Method Results Remarks Tissue studied: skin corrosion: in vitro / ex vivo Coverage: Vehicle: OECD Guideline 404 (Acute Dermal Irritation / Corrosion) Human information penetration time (in minutes) Value: ca Summary and discussion of corrosion 2 (reliable with restrictions) The studies with results indicating corrosivity are discussed in section Summary and discussion of irritation Sensitisation Skin Non-human information The results of studies on skin sensitisation are summarised in the following table: Table 5.8. Studies on skin sensitisation Method Results Remarks in vitro study skin sensitisation: in vitro Results: 1 (reliable without restriction) 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 21

27 OECD Guideline 406 (Skin Sensitisation) Human information Respiratory system Non-human information Human information <Put parameter here> ca.20 (no indication of skin sensitisation) Summary and discussion of sensitisation 5.6. Repeated dose toxicity Non-human information Repeated dose toxicity: oral The results of studies are summarised in the following table: Table 5.9. Studies on repeated dose toxicity after oral administration Method Results Remarks short-term repeated dose toxicity: oral Vehicle: Exposure: OECD Guideline 407 (Repeated Dose 28- Day Oral Toxicity in Rodents) Repeated dose toxicity: inhalation The results of studies are summarised in the following table: NOAEL: 45 mg/kg diet7.5.1 basis/ remarks Table Studies on repeated dose toxicity after inhalation exposure Method Results Remarks 1 (reliable without restriction) 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 22

28 sub-chronic toxicity: inhalation Vehicle: Exposure: OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study) [./.] NOAEC: >20 mg/l air (nominal)7.5.2 basis4effect/remarks 2 (reliable with restrictions) Repeated dose toxicity: dermal The results of studies are summarised in the following table: Table Studies on repeated dose toxicity after dermal administration Method Results Remarks short-term repeated dose toxicity: dermal Coverage: Vehicle: Exposure: OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study) Repeated dose toxicity: other routes Human information NOEL: >50 mg/kg bw/day (nominal)7.5.3basis4effect/remarks Summary and discussion of repeated dose toxicity 5.7. Mutagenicity Non-human information In vitro data The results of in vitro genotoxicity studies are summarised in the following table: Table The results of in vitro genotoxicity studies are summarised in the following table: Method Results Remarks bacterial gene mutation assay [gene mutation] (in vitro gene mutation study Test results: positive for S. typhimurium TA 1535 [bacteria]; 2 (reliable with restrictions) 1 (reliable without restriction) 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 23

29 in bacteria - Type of genotoxicity: gene mutation) S. typhimurium TA 1535 [bacteria] (Met. act.: with) Test concentrations: OECD Guideline 471 (Bacterial Reverse Mutation Assay) [in vitro gene mutation study in bacteria] bacterial forward mutation assay [in vitro gene mutation study in bacteria] (in vitro gene mutation study in bacteria - Type of genotoxicity: gene mutation) S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 [bacteria] (Met. act.: with and without) Test concentrations: OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay) [in vitro gene mutation study in bacteria (before 21 July 1997)] In vivo data Human information met. act.: with genotoxicity: positive cytotoxicity: yes vehicle controls valid: negative controls valid: positive controls valid: Remark: Test results: positive for E. coli WP2 [bacteria]; met. act.: with and without genotoxicity: positive cytotoxicity: yes vehicle controls valid: negative controls valid: positive controls valid: Remark: 2 (reliable with restrictions) Summary and discussion of mutagenicity 5.8. Carcinogenicity Non-human information Carcinogenicity: oral Carcinogenicity: inhalation Carcinogenicity: dermal Carcinogenicity: other routes Human information Summary and discussion of carcinogenicity 5.9. Toxicity for reproduction 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 24

30 Effects on fertility Non-human information The results of studies on fertility are summarised in the following table: Table Studies on fertility Method Results Remarks three-generation reproductive toxicity Vehicle: Exposure: EPA OPP 83-4 (Reproduction and Fertility Effects) Human information Developmental toxicity Non-human information Human information First parental generation (P0) NOAEC (PO) 78 mg/kg bw/day (actual dose received)) (male/female) based on: xxxx Second parental generation (P1) F1 generation NOAEC (PO): 1 mg/kg bw/day (nominal) (female) based on: basis4effect F2 generation Overall reproductive toxicity not specified Lowest effective dose / concentration Relation to other toxic effects: Summary and discussion of reproductive toxicity Other effects Non-human information Neurotoxicity Immunotoxicity Specific investigations: other studies Human information 1 (reliable without restriction) Summary and discussion of other effects 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 25

31 5.11. Derivation of DNEL(s) and other hazard conclusions Overview of typical dose descriptors for all endpoints Selection of the DNEL(s) or other hazard conclusions for critical health effects Table Hazard conclusions for workers Route Type of effect Hazard conclusion Most sensitive endpoint Inhalation Systemic effects - Long-term Inhalation Systemic effects - Acute Inhalation Inhalation Local effects - Longterm hazard unknown (no further information necessary) insufficient data available (further information necessary) low hazard (no threshold derived) Local effects - Acute hazard unknown (no further information necessary) Dermal Systemic effects - Long-term Dermal Systemic effects - Acute Dermal Dermal Local effects - Longterm hazard unknown (no further information necessary) hazard unknown (no further information necessary) high hazard (no threshold derived) Local effects - Acute medium hazard (no threshold derived) Eyes Local effects no hazard identified Inhalation Systemic effects - Long-term DNEL derivation method: Dose descriptor starting point: Modified dose descriptor starting point: Overall Assessment Factor: Inhalation Systemic effects - Acute DNEL derivation method: Dose descriptor starting point: Modified dose descriptor starting point: Overall Assessment Factor: Inhalation Local effects - Long-term DNEL derivation method: Dose descriptor starting point: Overall Assessment Factor: Inhalation Local effects - Acute DNEL derivation method: Dose descriptor starting point: Overall Assessment Factor: Dermal Systemic effects - Long-term DNEL derivation method: 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 26

32 Dose descriptor starting point: Modified dose descriptor starting point: Overall Assessment Factor: Dermal Systemic effects - Acute DNEL derivation method: Dose descriptor starting point: Modified dose descriptor starting point: Overall Assessment Factor: Dermal Local effects - Long-term DNEL derivation method: Dose descriptor starting point: Overall Assessment Factor: Dermal Local effects - Acute DNEL derivation method: Dose descriptor starting point: Overall Assessment Factor: : Text Table Hazard conclusions for the general population Route Type of effect Hazard conclusion Most sensitive endpoint Inhalation Systemic effects - Long-term Inhalation Systemic effects - Acute Inhalation Inhalation Local effects - Longterm medium hazard (no threshold derived) hazard unknown (no further information necessary) hazard unknown (no further information necessary) Local effects - Acute insufficient data available (further information necessary) Dermal Systemic effects - Long-term Dermal Systemic effects - Acute Dermal Dermal Local effects - Longterm high hazard (no threshold derived) high hazard (no threshold derived) high hazard (no threshold derived) Local effects - Acute hazard unknown (no further information necessary) Oral Systemic effects - Long-term Oral Systemic effects - Acute hazard unknown (no further information necessary) insufficient data available (further information necessary) Eyes Local effects no hazard identified Inhalation Systemic effects - Long-term DNEL derivation method: Dose descriptor starting point: Modified dose descriptor starting point: 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 27

33 Overall Assessment Factor: Inhalation Systemic effects - Acute DNEL derivation method: Dose descriptor starting point: Modified dose descriptor starting point: Overall Assessment Factor: Inhalation Local effects - Long-term DNEL derivation method: Dose descriptor starting point: Overall Assessment Factor: Inhalation Local effects - Acute DNEL derivation method: Dose descriptor starting point: Overall Assessment Factor: Dermal Systemic effects - Long-term DNEL derivation method: Dose descriptor starting point: Modified dose descriptor starting point: Overall Assessment Factor: Dermal Systemic effects - Acute DNEL derivation method: Dose descriptor starting point: Modified dose descriptor starting point: Overall Assessment Factor: Dermal Local effects - Long-term DNEL derivation method: Dose descriptor starting point: Overall Assessment Factor: Dermal Local effects - Acute DNEL derivation method: Dose descriptor starting point: Overall Assessment Factor: Oral Systemic effects - Long-term DNEL derivation method: Dose descriptor starting point: Modified dose descriptor starting point: Overall Assessment Factor: Oral Systemic effects - Acute DNEL derivation method: Dose descriptor starting point: Modified dose descriptor starting point: Overall Assessment Factor: : Text 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 28

34 6. HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES 6.1. Explosivity Data waiving: see CSR section 1.3 Physicochemical properties. Classification according to GHS Name: Related composition: Standard composition Classification: 6.2. Flammability Flammability The available information on flammability is summarised in the following table: Table 6.1. Information on flammability Method Results Remarks flammable solids EU Method A.10 (Flammability (Solids)) Flash Point Study results: Flammable gasses (lower and upper explosion limits): Aerosols: Flammable solids: Data waiving: see CSR section 1.3 Physicochemical properties. Classification according to GHS Name: Related composition: Standard composition Classification (gas): Classification (liquid): Classification (solid): 6.3. Oxidising potential burning time (test type not further specified) - or specified in description of method (migrated information) burning time: >=78 - <=89 s Pyrophoric solids: Pyrophoric liquid: Self-heating substances/mixtures: Substances/ mixture which in contact with water emit flammable gases: The available information on the oxidising potential is summarised in the following table: Table 6.2. Information on oxidising potential Method Results Remarks 2 (reliable with restrictions) 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 29

35 oxidising solids EU Method A.17 (Oxidising Properties (Solids)) Test results: Oxidising solids: test mixture (not specified) - migrated information: maximum burning rate: 20 h 1 (reliable without restriction) Classification according to GHS Name: Related composition: Standard composition Classification (gas): Classification (liquid): Classification (solid): 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 30

36 7. ENVIRONMENTAL HAZARD ASSESSMENT 7.1. Aquatic compartment (including sediment) Fish Short-term toxicity to fish Data waiving Information requirement: Short-term toxicity testing on fish Reason: study scientifically not necessary / other information available Justification: the study does not need to be conducted because the substance is unlikely to cross biological membranes, hence indicating that aquatic toxicity is unlikely to occur [study scientifically not necessary / other information available] Long-term toxicity to fish Aquatic invertebrates Short-term toxicity to aquatic invertebrates The results are summarised in the following table: Table 7.1. Short-term effects on aquatic invertebrates Method Results Remarks OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) LC50 (48h): 1 mg/l Long-term toxicity to aquatic invertebrates Algae and aquatic plants The results are summarised in the following table: Table 7.2. Effects on algae and aquatic plants Method Results Remarks 1 (reliable without restriction) 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 31

37 toxicity to aquatic algae and cyanobacteria OECD Guideline 201 (Alga, Growth Inhibition Test) [before 23 March 2006] Effects on algae / cyanobacteria Effects on aquatic plants other than algae Sediment organisms EC50 (1wk): >150 mg/l 1 (reliable without restriction) Other aquatic organisms 7.2. Terrestrial compartment Toxicity to soil macro-organisms of effects on soil macro-organisms except arthropods of effects on soil dwelling arthropods Toxicity to terrestrial plants Toxicity to soil micro-organisms Toxicity to other terrestrial organisms 7.3. Microbiological activity in sewage treatment systems The results are summarised in the following table: Table 7.3. Effects on micro-organisms Method Results Remarks EC50 (1d): 10 mg/l 1 (reliable without restriction) 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 32

38 OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test [before 22 July 2010] 7.4. Non compartment specific effects relevant for the food chain (secondary poisoning) Toxicity to birds Toxicity to mammals 7.5. PNEC derivation and other hazard conclusions Table 7.4. Hazard assessment conclusion for the environment Compartment Hazard conclusion Freshwater Marine water Sediments (freshwater) Sediments (marine water) Sewage treatment plant Soil Air Secondary poisoning no data: aquatic toxicity unlikely: Intermittent releases: no data available: testing technically not feasible: Intermittent releases: no exposure of sediment expected: no data available: testing technically not feasible: no data: aquatic toxicity unlikely: no hazard identified: no hazard identified: no potential for bioaccumulation: Remarks/Justification PNEC intermittent release hazard assessment conclusion: No hazard identified Conclusion on environmental classification General discussion 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 33

39 8. PBT AND vpvb ASSESSMENT 8.1. Assessment of PBT/vPvB Properties PBT/vPvB criteria and justification Assessed substance: not specified Composition of assessed substance: PBT status of the assessed substance: Remark for assessed substance: Persistence assessment - Remarks on ready biodegradability: - Remarks on other screening test(s) (e.g. enhanced ready biodegradability, inherent biodegradability) under valid conditions: - Remarks on Annex XIII criteria (P/vP): T1/2<=60 days in marine water: T1/2<=40 days in fresh- or estuarine water: T1/2<=180 days in marine sediment: T1/2<=120 days in fresh- or estuarine sediment: T1/2<=120 days in soil: - Remarks on Annex XIII criteria (P/vP): T1/2<=60 days in marine, fresh- or estuarine water: T1/2<=180 days in marine, fresh- or estuarine sediment: T1/2<=180 days in soil: Conclusion on P / vp properties: No conclusion can be reached based on available information Bioaccumulation assessment - Remarks on criterion "BCF<=2000 L/kg": - Remarks on criterion "2000<BCF<=5000 L/kg" Toxicity assessment - Remarks on Annex XIII criteria (T): Summary and overall conclusions on PBT or vpvb properties PBT assessment Assessed composition: Overall conclusion: Based on the assessment described in the subsections above the submission substance is not a PBT / vpvb substance Emission characterisation 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 34

40 9. EXPOSURE ASSESSMENT (and related risk characterisation) 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 35

41 10. RISK CHARACTERISATION RELATED TO COMBINED EXPOSURE 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 36

42 Annexes

43 1. Annex: s : Example Study Report (study report), Testing laboratory: Example Labs, Report no: 400. Report date: 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 38

44 2. Annex: Information on Test Material : Glucose Form: powder Composition type: Constituent substance: Glucose EC no.: CAS no: IUPAC name: Concentration range: >=99 - <=100 % (w/w) Additional information: Composition / purity: analytical grade Details on test material: - State of aggregation: - Particle size distribution: - Mass median aerodynamic diameter (MMAD): - Geometric standard deviation (GSD): - Shape of particles: - Surface area of particles: - Crystal structure: - Coating: - Surface properties: - Density: - Moisture content: - Residual solvent: - Activation: - Stabilisation: - Other: 21/04/2017 Generated by IUCLID 6 v1.2.0 Chemical Safety Report 39