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Description of key information

Only one acute oral study (BASF, 2009; Report No. 10A0645/089069) performed according to the OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) is available. The LD50 was estimated to be higher than 2000 mg/kg in female rats.

Key value for chemical safety assessment

Additional information

In the acute oral study performed according to the OECD Guideline 423, the starting dose of 2000 mg/kg body weight (10 ml/kg of a 20 g/100 ml test substance in olive oil Ph.Eur) had been chosen in the first step with 3 female animals. Because no animal died at the first step, 2000 mg/kg body weight was administered to another group of 3 female animals in the second step.

 

The animals were observed for a total of 14 days. During the period, the individual body were weighted shortly before administration (day 0), weekly thereafter and on the last day of observation. Signs and symptoms were recorded several times on the day of administration, at least once each workday for the individual animals. A check for any dead or moribund animal was made twice each workday and once on weekends and on public holidays.

Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2- inhalation in a chamber with increasing concentrations over time. Organ weights were also determined at necropsy.

 

No mortality occurred during the study. No abnormalities were observed in clinical observation, body weight determination or gross pathological examination. Therefore, under the conditions of this study the median lethal dose of Gelb LD 6259 after oral administration was found to be greater than 2000 mg/kg body weight in female rats.

Justification for classification or non-classification