Registration Dossier

Administrative data

Description of key information

The acute oral toxicity of the test substance was assessed, and the LD50 value was determined to be greater than 2000 mg/kg bodyweight.

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 dermal route

Endpoint conclusion

Additional information

An acute oral toxicity study was performed by Huntingdon Life Sciences, UK, to determine the acute oral toxicity of the test substance. The study was conducted to EEC, OECD, EPA and Japanese test guidelines, and complied to GLP. Groups of six female rats were dosed by oral gavage at 2000 mg/kg bodyweight, then observed for 14 days prior to necropsy. No deaths occurred during the study. No clinical signs were observed after dosing or during the observation period. No treatment-related macroscopic pathological signs were observed. The acute median lethal oral dose (LD50) to rats of the test substance was demonstrated to be greater than 2000 mg/kg bodyweight.

Justification for classification or non-classification

An assessment of the acute oral toxicity of the test substance was performed. The acute median lethal oral dose (LD50) to rats was found to be greater than 2000 mg/kg bodyweight. The test substance does not require classification according to EC Directive 67/548/EEC on the basis of this result.