Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

UBTL Inc. (1992) reported about the acute oral toxicity in rats. Male and female Sprague-Dawley rats were administered (gavage) the test substance dissolved in olive oil. Concentrations used were 1000, 2000 or 5000 mg/kg. No mortalities were seen in the lowest dose concentration; 2000 mg/kg - 6/10, 5000 mg/kg 9/10. All animals died within 24 hours. Clinical signs: Eight of the 5000 mg/kg dose group animals, 10 of the 2000 mg/kg dose group animals and 8 of the 1000 mg/kg dose group animals exhibited one or more of the following observations during their respective 14 day observation periods: oral discharge, nasal discharge, ocular discharge, alopecia, abnormal respiration, tremors, abnormal stools, lethargy and/or moribundity. Seven of the vehicle control animals appeared normal throughout the study period. Two of the animals exhibited abnormal stool on day 0 and an additional animal exhibited stained coat on days 3-9 of the study period. The acute oral LD50 value was 2240 mg/kg.

No acute inhalation data are available. Exposure to the test substance as a 10 u (MMAD) dust at 42 mg/m3 did not lead to mortalities nor to any other treatment-related findings after 28-day exposure.

An acute dermal LD50 value was found to be > 2000 mg/kg (UBTL Inc., 1992). Male and female rabbits were covered occlusive with a concentration of 2000 mg/kg (undiluted test substance). The study duration was 24 hours. None of the animals died. All rabbits exhibited one or more of the following observations: abnormal stools, ocular discharge, erythema and edema at the test site. By day 13, none of the rabbits had any observable abnormalities. No visible lesions at necropsy were recorded.

Justification for classification or non-classification

Based on the available data, classification for acute toxicity is not warranted according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.