Environmental classification of antimony and its compounds under REACH (EC 1907/2006) and EU CLP (EC 1272/2008)

Transcription

1 Environmental classification of antimony and its compounds under REACH (EC 1907/2006) and EU CLP (EC 1272/2008) Claire Massey Adam Peters Karine Van de Velde Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

2 Overview Why classify? Introduction to REACH (EC 1907/2006) Introduction to EU CLP (EC 1272/2008) Classification process for soluble metals Available ecotoxicity data Case study: sodium hexahydroxoantimonate Classification process for poorly soluble metals Transformation dissolution tests Case studies: antimony metal, diantimony trioxide Classifications of antimony compounds Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

3 Why classify? Classification reflects the type and severity of the hazards of a substance or mixture Two major pieces of new Legislation that both include need to classify REACH CLP Generated new data, made companies share data => International Antimony Association (i2a) Aim to harmonise classifications Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

4 REACH (EC 1907/2006) REACH is the Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals in Europe Manufacturers and importers are required to submit hazard data All substances manufactured or imported at 1tpa and not excluded or exempt must be registered (No data, no market) Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

5 REACH (EC 1907/2006) Data requirements are tonnage dependent Companies must work together One substance, One dossier Uses must be identified Risk assessment may be required Deadlines are tonnage and classification dependent Classification based on the hazard data must be included Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

6 REACH (EC 1907/2006) First submission deadline was 30 th Nov 2010 ( 1000tpa, CMR 1tpa, R50/53 100tpa) Next deadline is 31 st May 2013 ( tpa) Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

7 REACH (EC 1907/2006) 3 antimony compounds registered in 2010: antimony metal, diantimony trioxide, sodium hexahydroxoantimonate Further 5 due to be registered in 2013/2018: antimony trichloride, diantimony tris(ethylene glycolate), sodium antimonate (A), diantimony pentoxide, antimony trisulfide REACH dossiers for the antimony substances already registered are available on the REACH dissemination portal: Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

8 CLP (EC 1272/2008) Classification, labelling and packaging regulation (CLP) implements the Globally Harmonised System (GHS) for classification in the EU Will replace the Dangerous Substances Directive (67/548/EEC) and Dangerous Preparations Directive (1999/45/EC) in a stepwise approach Deadline to notify was 3 rd Jan 2011 Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

9 CLP (EC 1272/2008) Manufacturers and importers must submit a classification to the C&L inventory, for all >1 tpa substances If a REACH dossier was submitted in 2010 this fulfilled CLP requirements The aim is to determine a harmonised classification for each substance, based on the notified classifications ECHA are due to publish the CLP inventory in 2011 Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

10 Classification of metal compounds Two different approaches 1. Standard criteria Used when solubility is > EC50 of soluble metal ion 2. Criteria for poorly soluble metals Used when solubility is < EC50 of soluble metal ion Current guidance Draft guidance (in consultation) Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

11 Available ecotoxicity data Published and proprietary ecotoxicity data All reliable antimony ecotoxicity data used The dataset for antimony contains acute and chronic data for algae, invertebrates and fish Lowest acute LC50 is 6.9 mg Sb L -1, for fish Chronic NOEC values are all > 1 mg Sb L -1 Ecotoxicity data also available for soil, sediment and STP micro-organisms but not used for C&L Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

12 Classification of soluble metal compounds Acute and chronic classifications determined based on acute aquatic ecotoxicity data for algae, crustacea and fish Chronic data can be used to remove some classifications Note: New classification criteria include the use of chronic data (2nd ATP to the CLP Regulation, mandatory from 1 st Dec 2012) Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

13 CLP standard classification criteria Lowest reliable acute ecotoxicity data (mg L -1 ) CLP classification <1 Acute Category 1 <1 Chronic Category 1* <10 Chronic Category 2* + <100 Chronic Category 3* + Other grounds for concern Chronic Category 4 + *unless rapidly degradable and not bioaccumulative + unless chronic NOEC >1 mg L -1 Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

14 Case study: Sodium hexahydroxoantimonate SHHA is considered soluble (~600 mg L -1 ) Therefore classified based on the ecotoxicity data for the metal ion (6.9 mg L -1 ) Based on this it would be classified for chronic toxicity Escape clause if chronic NOEC is > 1 mg L -1 All chronic NOECs are > 1 mg L -1 therefore no classification Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

15 Classification of poorly soluble metal compounds Alternative classification guidelines for poorly soluble metal compounds Based on comparison of acute ecotoxicity data for the soluble metal ion with the amount of dissolved metal ions released over time Determined from transformation / dissolution tests Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

16 T/D testing According to UN T/D protocol (1995) Loading rates of 1, 10 and 100 mg L -1 (7 day test) and 1 mg L -1 (28 day test) Tests carried out at ph 6 and ph 8.5 Measured concentration at each loading rate in 7 day test compared to the lowest acute EC50 Measured concentration in 28 day test is compared to the lowest chronic NOEC CANMET will publish Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

17 CLP classification criteria for poorly soluble metals Ecotoxicity data Concentration at 1 mg L -1 loading rate after 7 days > EC50 Concentration at 10 mg L -1 loading rate after 7 days > EC50 Concentration at 100 mg L -1 loading rate after 7 days > EC50 Concentration at 1 mg L -1 loading rate after 28 days > NOEC CLP classification Acute Category 1 and Chronic Category 1* Chronic Category 2* + Chronic Category 3* + Chronic Category 4 *unless rapidly partitioning and not bioaccumulative + unless concentration at 1 mg L -1 loading rate after 28 days < NOEC Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

18 Case study: Antimony powder Loading rate mg L -1 Days Dissolved concentration mg L -1 ERV mg L -1 Conclusion No classification Potentially classified Classification removed! Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

19 Case study: Antimony T/D test results for 10 and 100 mg L -1 loadings of Sb metal for 7 days Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

20 Case study: Diantimony trioxide Loading rate mg L -1 Days Dissolved concentration mg L -1 ERV mg L -1 Conclusion and and No classification No classification No classification No classification Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

21 Environmental Classifications Substance Classification Classification 2 nd ATP Antimony metal Not classified Not classified Diantimony trioxide Not classified Not classified Sodium hexahydroxoantimonate Not classified Not classified Diantimony tris (ethylene glycolate) Not classified Not classified Diantimony pentoxide Not classified Not classified Antimony pentachloride Not classified Not classified Antimony trichloride Not classified Not classified Sodium antimonate Not classified Not classified Antimony trisulfide Not classified Not classified Antimony triacetate Not classified Not classified Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug

22 Please contact us for further information Environmental classification of antimony International Antimony Workshop, Jena 22 nd Aug