Registration Dossier

Administrative data

Description of key information

oral 
rat: LD50 > 5000 mg/kg bw; no signs of toxicity (non-GLP, OECD 401; BASF AG, 1982)

dermal
rat: LD50 > 2000 mg/kg bw; no signs of toxicity (GLP, OECD 402; BASF SE, 2009)

inhalation
No data available

Key value for chemical safety assessment

Additional information

There are reliable studies available to assess the acute oral and dermal toxicity of the test substance.

oral

 

An acute toxicity study following oral administration of test item Oxooel 13 in young adult Wistar rats was performed according to a limit test of OECD guideline 401 (BASF AG, 1982).

To a group of ten fasted animals (five males and five females) a single oral dose of the test material (dose volume: 10 ml/kg bw) in 0.5 % carboxymethylcellulose at a dose level of 5000 mg/kg body weight was given.

No mortality occurred in this study.

No signs of systemic toxicity effects were observed in the animals.

The mean body weight of the male animals increased throughout the study period within the normal range.

No macroscopic pathologic and histopathologic abnormalities were noted in the animals examined at the end of the study.

Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 5000 mg/kg body weight for the male and female animals.

dermal

 

In a GLP conform acute dermal limit test, young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of undiluted test item Oxooel 13 according to the OECD guideline 402 (BASF SE, 2009). The test substance was administered to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi occlusive dressing for 24 hours. The application area comprised at least 10% of body surface area. The animals were observed for 14 days.

No mortality occurred. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw.

No signs of systemic toxicity or skin effects were observed in the animals.

The mean body weight of the male animals increased throughout the study period within the normal range. The mean body weight of the female animals slightly increased throughout the study period.

No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

 

Under the conditions of this study the median lethal dose of the test substance after dermal application was found to be greater than 2000 mg/kg body weight for the male and female animals.

 

inhalation

no data available

Justification for classification or non-classification

Oral and dermal

 

Dangerous Substance Directive (67/548/EEC):

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008.

 

inhalation

No data available.