Registration Dossier

Administrative data

Description of key information

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat, was found to be greater than 2000 mg/kg body-
weight.
The acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw

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
Quality of whole database:
Klimisch 2 study. The registered substance is a UVCB material which contains substances of varying chain length. Read across was performed to an analogous material whose carbon chain length differs by an average of two CH2-groups from the registered substance. Because of the UVCB nature of these substances, the components of the registered substance were also present in the test material, albeit at slightly different concentration levels.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Klimisch 2 study.

Additional information

To determine the acute oral median lethal dose (LD50), a study was performed with L-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS 68187-32-6). A group of ten fasted animals (five males and five females) was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight. There were no deaths. No evidence of systemic toxicity was noted during the study period. No toxicologically significant effects on bodyweight were noted during the study period. No abnormalities were noted at necropsy of animals killed at the end of the study. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley rat was found to be greater than 2000 mg/kg body-weight.

In an acute dermal toxicity study (limit test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted test item L-Glutamic acid, N-coco acyl derivs., disodium salts(CAS 68187-30-4)to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No mortality, clinical signs or macroscopic changes occurred. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw.

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

Justification for classification or non-classification

No classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.