Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50 > 2000 mg/kg bw (rat); OECD Guideline Study, RCC 1990
Acute dermal toxicity: LD50 > 2000 mg/kg bw (rat); OECD Guideline Study, RCC 1990

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity in rat:

The acute oral toxicity of the test article in 5 male rats and 5 female rats was tested according to OECD guideline 401 (RCC 1990). A single dose of 2000 mg/kg body weight was administered through gavage. The rats were observed for a total period of 15 days. No mortality and abnormal clinical signs occurred and normal body weight gain was found in this study. At autopsy, no macroscopic organ changes were observed. LD50 rat oral = > 2000 mg/kg

Acute dermal toxicity in rat:

A single dose of 2000 mg/kg body weight, was administered to the backs of 5 male and 5 female rats according to OECD guideline 402 (RCC 1990). The test article was applied evenly over an area of 10% and covered with a semi-occlusive dressing. The rats were exposed to the test article for 24 hours. The rats were then observed for a further 15 days. Local effects were scales and discoloration (blue skin). No mortality and no systemic symptoms were observed. LD50 rat dermal = > 2000 mg/kg

Acute inhalation toxicity:

No study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for acute toxicity is not warranted under Directive 67/548/EEC.

 

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

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No.1272/2008.