Registration Dossier

Administrative data

Description of key information

Subacute toxicity (oral): NOAEL of 1,000 mg/kg/day for rat (EEC Directive 92/69/EEC, Method B7)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

n a 28-day repeateddose oral toxicity study in rats, there were statistically significant findings related to clinicalbiochemical examinations, organ weight parameters, and macroscopic and microscopic changes in the kidney and lung. However, the findings were not dose-related and were considered not to be treatment-related. The results of the study allowed an NOAEL of 1,000 mg/kg/day (highest dose tested) to be clearly established.

This study was utilized as a key study in substance repeated dose toxicity evaluation due to the high adequacy, reliability and relevance to thisendpoint.

Justification for classification or non-classification

According to the existing 28-day repeated dose oral toxicity test in laboratory animals, BDP was considered as low toxicity via oral route. Further studies which focus on other administration routes such as inhalation and dermal exposure may depend on the nature of the substance and the likely route of human exposure.