Registration Dossier

Administrative data

Description of key information

Acute toxicity after single oral application was tested in male and female rats, which received 2,000 mg/kg bw. No animal died or showed clinical symptoms/macroscopic anomalies. The necropsy did not reveal any effect. The LD50 value for acute oral toxicity was considered to be greater than 2,000 mg/kg bw. Due to the findings described above (LD50 oral in rats greater than 2,000 mg/kg bw) the test item does not have to be classified as acute orally toxic.
Five male and five female rats were treated with the test substance at 2,000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.5 g/mL and administered at a volume dosage of 4 mL/kg. The application period was 24 hours. No deaths occurred. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The median lethal dose of the test substance after single dermal administration to rats of both sexes, observed over a period of 14 days is LD50 (rat): greater than 2,000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
reliable without restriction

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
reliable without restriction

Additional information

Based on the results of the oral toxicity and dermal toxicity studies the LD50value for acute oral and dermal toxicity was considered to be greater than 2,000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Guideline conform GLP study

Justification for selection of acute toxicity – dermal endpoint
Guideline conform GLP study

Justification for classification or non-classification

Due to the findings described in the acute oral toxicity and dermal toxicity studies (LD50oral/dermal in rats greater than 2,000 mg/kg bw) the test substance does not have to be classified as acute orally or dermally toxic. Therefore, the test item does not have to be classified as acute toxic.