Registration Dossier

Administrative data

Description of key information

The key study for acute oral toxicity reports an LD50 of >2000 mg/kg bw, in a reliable study conducted according to OECD TG 401 and in compliance with GLP  (Hoechst, 1998).

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

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key study for acute oral toxicity was conducted according to OECD TG 401 and in compliance with GLP (Hoechst, 1998). The animals showed impairment of motility and respiration as well as narrowed palpebral fissure. Symptoms were reversible after one day. There were no treatment-related body weight changes or mortalities. Narrowed palpebral fissure was reported but there were no macroscopically visible changes at necropsy. The LD50 was determined to be >2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
The study was conducted according to an appropriate guideline and in compliance with GLP.

Justification for classification or non-classification

Based on the available acute oral toxicity study, no classification is required for the registered substance in accordance with Regulation (EC) No. 1272/2008.