Registration Dossier
Registration Dossier
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EC number: 248-704-9 | CAS number: 27871-49-4
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil macroorganisms except arthropods: short-term
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Description of key information
According to column 2 of Annex IX, section 9.4, testing on short term toxicity on terrestrial organisms does not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. Additionally, in accordance to the chemical safety assessment performed in line with REACH Annex I, there are no unacceptable risks for terrestrial organisms.
Key value for chemical safety assessment
Additional information
According to column 2 of Annex IX, section 9.4, testing of short term toxicity to terrestrial organisms does not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. The intended uses of methyl-(S)-lactate do not result in direct release to soil. Potential indirect exposure of soil and the associated risk is assessed using the equilibrium partitioning method. According to the chemical safety assessment performed in line with REACH Annex I, there are no unacceptable risks for terrestrial organisms. Annex IX, column 2, section 9.4 of the REACH Regulation further states that long-term terrestrial toxicity testing shall particularly considered for strongly adsorbing or very persistent substances. However, methyl-(S)-lactate has a low potential for adsorption to soil (estimated Koc = 1) and is readily biodegradable. The hazard and risk assessment performed using the equilibrium partitioning method thus can be considered fully adequate. Furthermore, the hazard assessment for methyl-(S)-lactate neither results in classification of the substance as dangerous to the environment, nor is it a PBT or vPvB substance. Therefore, following the criteria of REACH Annex IX, point 9.4., column 2, terrestrial toxicity studies are not considered to be required.
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