Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

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
Quality of whole database:
Although the study has some restrictions, it is considered to fulfill basic requirements of data reporting.

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

The repeated dose toxicity of N-cocoacyl glutaminic acid, sodium salts, a close homologe of the registered substance (see justification for read across below), has been investigated in male albino rats. The animals received 0 or 1200 mg/kg bw per day for a treatment period of 112 days. No mortality or clinical signs were observed during treatment. The body weight development did not differ statistically between dose and control group.

After necropsy the following parameters were assessed: relative organ weights of liver, kidneys, testes, adrenals, spleen. The following clinical chemical and hematological parameters were: hemoglobin, total serum protein, total liver protein, ascorbic acid in adrenals, testes and liver tissue. All values were statistically not different between control and dose groups or were within historical controls. The authors conclude that the NOAEL was >1200 mg/kg bw.

Although the study has its limitations in terms of documentation and parameters assessed, the result reflects the fact that during hydrolysis the test substance forms two physiological cleavage products: Coco fatty acids and glutamic acid. Both are natural constituents of conventional foods which are consumed on a gram per day level. Under these circumstances it is scientifically not justified to repeat the subchronic study in order to fill potantial data gaps (histopathology, missing organ weights and clinical chemical and hematological parameter, missing female animals). Therefore, the NOAEL of 1200 mg/kg bw is considered to be a valid point of departure.

The read across justification is given in an extra rationale document.

Justification for classification or non-classification