Registration Dossier

Administrative data

Description of key information

The acute oral LD50 of (Z)-4-[C11-13 (branched) alkylamino]-4-oxo-2-butenoic acid after single oral administration to female rats is > 2000 mg/kg bw.
The acute dermal LD50 of (Z)-4-[C11-13 (branched) alkylamino]-4-oxo-2-butenoic acid after single dermal application in male and female rats is > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Additional information

Acute oral toxicity

In a GLP compliant study, according to OECD guideline 423, the acute oral toxicity of (Z)-4-[C11-13 (branched) alkylamino]-4-oxo-2-butenoic acid following a single oral administration in female Wistar rats was investigated (Bioassay, 2012). Two groups of fasted animals (3/group) were treated by gavage with (Z)-4-[C11-13 (branched) alkylamino]-4-oxo-2-butenoic acid without a vehicle at a dose level of 2000 mg/kg bw and observed for 14 days. All animals survived until the end of the study period. The following clinical signs were observed: Impaired general state in five animals, dyspnoea in five animals, piloerection in five animals, exsiccosis in one animal, reduced feces in one animal. The mean body weight in both administration groups increased within the normal range during the first post-exposure week, but remained constant during the second week in the second test group only. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period. The acute oral LD50of (Z)-4-[C11-13 (branched) alkylamino]-4-oxo-2-butenoic acid after single oral administration to female rats is > 2000 mg/kg bw.

Acute dermal toxicity

In a GLP compliant study, according to OECD guideline 402, the acute dermal toxicity of (Z)-4-[C11-13 (branched) alkylamino]-4-oxo-2-butenoic acid following a single dermal application in male and female Wistar rats was investigated (Bioassay, 2012). A group animals (5/sex) was dermally exposed to (Z)-4-[C11-13 (branched) alkylamino]-4-oxo-2-butenoic acid without a vehicle at a dose level of 2000 mg/kg bw for 24 hours under semi-occlusive dressing and observed for 14 days. All animals survived until the end of the study period. There were no signs of systemic toxicity. The following test item-related local effects were recorded during the course of the study: very slight to moderate erythema (grade 1 to 3), very slight to slight edema (grade 1 to 2), incrustations and scaling. The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of the lightweight female animals did not significantly change during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. The acute dermal LD50of (Z)-4-[C11-13 (branched) alkylamino]-4-oxo-2-butenoic acid after single dermal application in male and female rats is > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the available acute oral and dermal toxicity studies, the substance was neither classified according to Directive 67/548/EEC nor according to CLP