Registration Dossier
Registration Dossier
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EC number: 206-126-4 | CAS number: 302-72-7
Endpoint summary
Administrative data
Description of key information
Measured short term toxicity of DL-Alanine (CAS no.:302 -72 -7) to aquatic invertebrates: EC50 (48h) > 100 mg/L for Daphnia magna (OECD TG 202, static). This result is supported by the results observed for L-Alanine (CAS no.: 56 -41 -7) for which a identical result was observed by Evonic (2012).
Measured toxicity to aquatic algae and cyanobacteria: EyC50 / ErC50 (72h) > 164 mg/L for Pseudokirchneriella subcapitata (OECD TG 201, static)
Estimated short term toxicity to fish: LC50 > 100 mg/L, Weight of evidence approach: Read across from L-Valine (72 -18 -4) and DL-Methionine (59 -51 -8) supported with an OECD QSAR Toolbox prediction (Version 2.3; data base version: 2.1.8/1.00) trend analysis).
Additional information
The available data show that DL-Alanine is non-toxic to aquatic invertebrates and algae. All LC50 and EC50 values are well above 100 mg/L.
The acute ecotoxicity to fish is, in the absence of measured data, based on a weight of evidence approach. Available data from two analogues i.e. L-Valine and DL-Methionine together with supporting information from an OECD toolbox prediction (using trend analysis), demonstrate that the 96h LC50 for fish of DL-Alanine is > 100 mg/L. The OECD toolbox prediction for the 96h LC50 for fish of Alanine was estimated to be 26300 mg/L. As a realistic worst-case a 96h LC50 for fish of >100 mg/L will be used for DL-alanine.
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. L-alanine is not hazardous for the environment, nor for human health. Therefore an exposure assessment within the Chemical Safety Assessment for L-alanine is not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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