Registration Dossier

Diss Factsheets

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 1 study

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 1 study

Additional information

A study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered undiluted, in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity" referenced as Method B.1 in Annex V of EEC Commission Directive 84/449/EEC. 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 strain 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 acylderivs., disodiumsalts 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 occured. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw.

The studies were in part conducted with a structurally similar substance, namely the monosodium salt. Solubility, bioavailability and toxicity of the surrogate are not expected to differ from the registered substance as the counter ion is not known for a specific toxicity and sodium salts are generally known to be of high solubility.

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.