Registration Dossier

Administrative data

Description of key information

In an acute oral toxicity study in mail and female Sprague-Dawley rats with the test substance,no deaths or adverse clinical signs were noted. There were no adverse necropsy findings.  The acute oral LD 50 value was found to be greater than 5000 mg/kg bw.  In an acute dermal toxicity study in mail and female New Zeland White rabbits with the test substance, no deaths were noted during the obsrvation period.  During necropspsy, it revealed liver and salivary gland discoloration in 1 animal; kidney discoloration and spleen enlargement in 1 animal and alopecia in 1 animal.  The acute dermal LD 50 value was found to be greater thn 3150 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 160 mg/kg bw

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
Value:
3 160 mg/kg bw
Quality of whole database:
The key result is based on the guideline study conducted in rabbits.

Additional information

Justification for classification or non-classification

This substance is not classified based on the Oral LD50 of >5000 mg/kg bw and dermal LD50 of >3160 mg/kg bw.