Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A study was conducted to determine the acute oral toxicity of the read-across substance L-glutamic acid, N-coco acyl derivs., monosodium salts according to OECD Guideline 401, in compliance with GLP. Male and female Sprague-Dawley rats were administered the test substance by oral gavage at a dose of 2000 mg/kg bw. Following administration, the animals were observed for 14 d and mortality, clinical signs and body weights were recorded daily. At the end of this period, rats were examined for macroscopic and microscopic abnormalities. There were no mortality in this study. No evidence of systemic toxicity was noted during the study period. No toxicologically significant effects on bodyweight were recorded during the study period and no abnormalities were seen at necropsy of animals killed at the end of the study. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be >2000 mg/kg bw (Safepharm Laboratories Limited, 1989a).

Justification for classification or non-classification

Based on an acute oral toxicity study with the read-across substance L-glutamic acid, N-coco acyl derivs., monosodium salts, the substance does not warrant classification for acute toxicity according to EU CLP (1272/2008) criteria.