Registration Dossier

Administrative data

Description of key information

Several acute oral toxicity studies were conducted on rats, mice and guinea pigs. 
For acute inhalation toxicity no studies were available.
For acute dermal toxicity a LD50 > 2000 mg/kg bw was found.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
980 mg/kg bw

Acute toxicity: via dermal route

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

Additional information

None of the acute oral toxicity studies complies fully with actual guidelines concerning the documentation or the used methods. Nevertheless, these studies were appropriate by a weight of evidence consideration to establish a LD50 value.

For rats a LD50 = 980 mg/kg bw was found, for mice a LD50 = 640 to 1800 mg/kg bw was found in several studies, and for guinea pigs a LD50 = 880 mg/kg bw was determined.

For acute inhalation toxicity no studies were available.

For acute dermal toxicity a LD50 > 2000 mg/kg bw was found; in this study no pathological changes and no signs of intoxication were observed.

Justification for classification or non-classification

Based on the studies on acute oral toxicty a LD50 = 880 (rat, male + female) is reliable. Therefore a classification as Xn, R 22 (GHS: acute tox 4, H 302) is justified.

For acute dermal toxicity no classification is required.