Registration Dossier

Administrative data

Description of key information

Oral: In the only available (and reliable study), the LD50 was determined to be > 2000 mg/kg bw.
Dermal: In the only available (and reliable study), the LD50 was determined to be > 2000 mg/kg bw.
Therefore, the test substance is practically not acutely toxic.

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

As exposure of humans via the inhalative route is unlikely, especially because of the low vapour pressure (below 0.014 Pa), testing of the inhalative route was not appropriate. Therefore, only the oral and dermal route were assessed, each based on one available (and reliable) study..

The acute oral toxicity of the test substance was investigated in a limit test study with the does of 2000 mg/kg bodyweight in a study similar to OECD test guideline 423. The study was performed in agreement with the OECD GLP-principles. To 5 female and 5 male Wister rats, the test substance was administered by oral gavage. No mortality, nor clinical signs were observed over 14d, while the bodyweight increased normally. According to these results, with a LD50 of > 2000 mg/kg bodyweight the test substance is considered practically non-toxic via the oral route.

The acute dermal toxicity of the test substance was investigated in a study according to OECD test guideline 402 under GLP. Based on the results from a pilot study with one rat, a limit test with the concentration of 2000 mg/kg bw was performed with 5 male and 5 female Wistar rats. The rats were exposed for 24 hours, during which the test substance was occlusively applied without any vehicle. Up to 6 hours after application, the rats appeared apathic. From day 1 to day 14 no mortality or clinical signs were observed. The body weight developed normally and no pathological abnormalities were found at the end of the study. Therefore, the test susbtance is considered to be practically nontoxic via the dermal route with an LD50 of larger than 2000 mg/kg bw.

Justification for classification or non-classification

As the test substance did not induce any acute toxicity at a does of 2000 mg/kg bw, it does not need to be classified with regard to acute toxicity.