Sodium hydrogen N-(1-oxododecyl)-L-glutamate

Endpoint summary

Description of key information

The acute oral median lethal dose (LD50) 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

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

A study was performed to determine the acute oral median lethal dose (LD50) of the test material: l-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS No. 68187-32-6) 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., 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 occured. Accordingly, the acute dermal median lethal dose (LD₅₀) was determined to be LD₅₀, dermal, rat > 5000 mg/kg bw.

The studies were conducted with structurally similar substances, namely l-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS No. 68187-32-6) and L-Glutamic acid, N-coco acylderivs., disodium salts (CAS 68187-30 -4). Solubility, bioavailability and toxicity of the surrogates are not expected to differ from the registered substance as the target substance is the major component, and the central member of an homologous series of components, of the source substances, possessing identical functional groups and extremely similar structures. It is reasonable to expect that the toxicological properties of the target and source substances will not be markedly different. On this basis, experimental data on the source substances are expected to be directly applicable to the target substance, and can be used to adequately predict its properties. Further details are provided in the filed "attached 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.