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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

An acute toxicity test according the acute toxic class method (OECD 423) was performed. In the first step the test item was given at a dose of 2000 mg/kg bw to a group of 3 female rats (HsdBrlHan:WIST) in a single exposure via oral gavage. In the second step the test item was given at the same dose to a further group of 3 female rats (HsdBrlHan:WIST) in a single exposure via oral gavage. No mortality occured during the study. General signs of toxicity were not observed. The body weight gain of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic findings were observed at necropsy. Therefore, the LD50 (oral, rat) was determined to be > 2000 mg/kg bw.

An acute dermal toxicity test according to OECD 423 was performed. The test item was administered topically at a single dose (2000 mg/kg bw) by applying uniformly over an area which was approx. 10% of the total body surface. 5 male animals (HsdRccHan:WIST rats) as well as 5 female animals (HsdRccHan:WIST rats) were used. The test item was held in cointact by an occlusive dressing with the skin throughout a 24 -hour period. No mortality occured during the study. No clinical signs of toxicity were observed throughout the observation period. The body weight gain of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic findings were observed at necropsy. Therefore, the LD50 (dermal, rat) was determined to be > 2000 mg/kg bw.

Justification for classification or non-classification

As no signs of toxicity were observed after oral and dermal application of 2000 mg/kg bw to rats, the product is not classified for acute toxicity.