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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

NOAEL  = 1200 mg/kg bw/day, oral, subchronic test

Key value for chemical safety assessment

Toxic effect type:
concentration-driven

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 200 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A study was conducted to determine the oral repeated dose toxicity of the read-across substance L-glutamic acid, N-coco acyl derivs., monosodium salts according to a method similar to OECD Guideline 408. The study was conducted in male albino rats. The animals received the test substance by oral gavage at 0 or 1200 mg/kg bw/day for a period of 112 d. No mortality or clinical signs were observed during treatment. The body weight development did not statistically differ between the treated and the control groups. The following clinical chemical and hematological parameters were recorded: hemoglobin, total serum protein, total liver protein, ascorbic acid in adrenals, testes and liver tissue. None of the values were statistically significant between control and dose groups or were within historical values. After necropsy, the relative organ weights of liver, kidneys, testes, adrenals and spleen were measured and did not reveal any difference between groups. Under the study conditions, the sub-chronic NOAEL of the substance in rats was determined to be 1200 mg/kg bw/day (Zaitsev, 1984).

Justification for classification or non-classification

Based on the results of a sub-chronic repeated dose toxicity study with the read across substamce L-glutamic acid, N-coco acyl derivs.,monosodium salts, no classificationis warranted for repeated dose toxicity according to EU CLP 1272/2008 criteria.