Registration Dossier
Registration Dossier
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EC number: 269-085-1 | CAS number: 68187-30-4
Endpoint summary
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 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 statistically did not differ 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 is 1200 mg/kg bw.
Although the study has its restrictions 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. Therefore, the NOAEL of 1200 mg/kg bw is considered to be a valid point of departure.
As the study has its restrictions in terms of documentation and parameters assessed, an additional test is proposed.
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
