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Description of key information

Acute oral toxicity is assessed in a study according to OECD test guideline 401, resulting in an  LD50 > 5000 mg/kg body weight.
Acute dermal toxicity is assessed in a study according to OECD test guideline 402, resulting in an LD50 > 2000 mg/kg body weight.

Key value for chemical safety assessment

Additional information

Acute oral toxicity.

In the key study, acute oral toxicity is assessed in a study according to OECD TG 401 and GLP, using groups of ten fasted Wistar rats (5 per sex) after administration of a single oral dose of octocrilene in olive oil DAB 9 at a dose level of 5000 mg/kg body weight. Under the conditions of this study LD50 was found to be > 5000 mg/kg body weight for the male and female animals (BASF 10A0227/921093).

Acute dermal toxicity.

In the key acute dermal toxicity study according to OECD TG 402 and GLP,  groups of young adult Sprague-Dawley rats (5/sex) were dermally exposed to octocrilene for 24  hours to 10% of body surface area at a limit dose of  2000 mg/kg bw (Symrise 1992035).  No mortality, treatment related clinical signs or systemic toxicity, necropsy findings or changes in body weight were observed. LD50 was found to be >2000 mg/kg bw for the male and female animals.

Acute inhalative toxicity.

In light of the accumulated study results on the test substance octocrilene from acute oral and dermal toxicity studies, and the fact, that inhalative exposure is not considered to be the main route of exposure, an acute toxicity study via the inhalative route is scientifically not required and is not in line with animal welfare requirements.

The reasons for the present data waiving is based on the following study results:

-        Acute oral toxicity study revealed a LD50 > 5000 mg/ kg bw (BASF 10A0227/921093)

-        Acute dermal toxicity study revealed a LD50 > 2000 mg/ kg bw (Symrise 1992035)

Justification for classification or non-classification

According to the criteria laid down under 67/548/EEC and CLP, a non-classification of octocrilene is warranted.