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Administrative data

Description of key information

The LD50 values for acute exposure to the test item (described in section 1.2) by the oral or dermal route are > 2000 mg/kg bw (OECD 401 and 402, GLP). No mortality occured.

Key value for chemical safety assessment

Additional information

Acute toxicity: oral route

In an acute oral toxicity study (RCC Notox BV, 1993), groups of young adult Wistar rats (5 animals/sex) were given a single oral gavage dose of the test item in propylene glycol at 2000 mg/kg bw (dose volume: 10 mL/kg bw) and observed for 15 days. There was no mortality or changes in body weight noted during the study period. Clinical signs observed among all animals included blue discoloured faeces, salivation and hunched posture. These symptoms had disappeared in all animals at day 12 of the observation period. At necropsy, greyish discolouration of abdominal fat and enlarged stomach with watery contents were noted in females only. Under the conditions of this study, the oral LD 50 for male and female rats was >2000 mg/kg bw.

Acute toxicity: dermal route

In an acute dermal toxicity study (RCC Notox BV, 1993), groups of fasted young adult Wistar rats (5 animals/sex) were dermally exposed to the test item in propylene glycol at 2000 mg/kg bw (dose volume: 10 mL/kg bw) for 24 hours. Animals then were observed for 15 days. No mortality and no treatment related clinical signs were observed during the study period. Body weights were only affected during the first observation week. Bluish discolouration was seen in the snout, tail, treated skin and surrounding area as well as abdominal fat. Thus, under the conditions of this study, the dermal LD50 for males and females was >2000 mg/kg bw.

Justification for classification or non-classification

Based on the results of the acute oral and dermal key toxicity studies, the test item is not subject to classification and labelling for acute toxic effects according to Directive 67/548/EEC and Regulation 1272/2008/EC.