Registration Dossier
Registration Dossier
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EC number: 200-811-1 | CAS number: 74-79-3
Endpoint summary
Administrative data
Description of key information
Additional information
A limit test according to OECD 203 did not show any adverse effects to fish at a test concentration of 1 g/L L-arginine. A subsequent test with L-arginine according to OECD 203 with higher test concentrations showed the following results: LC50 = 2.8 g/l; LC 100 = 5.6 g/l; NOEC (mortality) = 1.8 g/l; NOEC (condition) = 1.0 g/l.
A limit test according to OECD 202 did not show any adverse effects to Daphnia magna at a test concentration of 1 g/l. A subsequent test according to OECD 202 with higher test concentrations showed that L-arginine did not cause mortality up to the maximum test concentration of 10 g/l.
EC50 was found to be 1.8 g/l, EC100 was found to be 5.6 g/l.
NOEC (mobility) was estimated to be 1.0 g/l and NOEC (condition) was estimated to be < 1.0 g/l.
L-Arginine did not show toxicity to microorganisms. The EC10 after 16 h was > 10 g/kg.
EC50 for algae was calculated to be ca. 26857 mg/L.
Considering the results from higher trophic levels as well as for microorganisms 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-arginine 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-arginine is not required.
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