Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

L-valine did not show any acute toxicity effects to fish in a GLP guideline study according to OECD 203. Both LC50 and LC100 > 10 g/L, NOEC (mortality; condition) >= 10 g/L.

L-valine did not cause mortality in a GLP guideline study according to OECD 202 up to the maximum test concentration of 10 g/l. EC100 (mobilty) was > 10 g/l. NOEC (mobility) was estimated to be < 10 g/l and NOEC (condition) was estimated to be 3.2 g/l.

L-valine did not show toxicity to microorganisms in a test according to (draft) DIN 38 412, L8 with the test organism Pseudomonas putida. The EC 10 after 16 h was > 9.9 g/kg.

EC50 for algae was calculated to be ca. 2651 mg/L.

Considering the results from higher trophic levels and for microorganisms, read across from L-alanine and an expert statement (see endpoint summary in IUCLID section 6.1.5) toxicity testing with aquatic algae was not deemed necessary.

The results do not trigger classification.

In respect of REACH Art. 14 in conjunction with REACH Annex I a CSA is required which includes an exposure assessment if the particular substance fulfils the criteria for any of most hazard classes or categories set out in Annex I to regulation 1272/2008 or is assessed to be a PBT / vPvB (for details see REACH Annex I, Section 0.6.3.). Annex I, Section 5.0 of the REACH Regulation states that the exposure assessment “shall cover any exposures that may relate to the hazards identified in Sections 1 to 4”.

Thus REACH requires that the exposure assessment is closely linked to the hazard assessment, which may identify hazards either for the environment, or for human health, or for both. The hazard assessment (including the classification) as well as the performance of an exposure assessment are focused either on possible effects on the environment or on possible effects on human health. Thus, any substance of a nature identified as hazardous to human health (and a respective classification) triggers an assessment of the exposure of humans, but not of the environment. L-valine does not fulfil the criteria relating to environmental hazards (wording of EU-GHS, in particular Art. 3). Thus an exposure assessment within the Chemical Safety Assessment for L-valine is not required.