Registration Dossier

Administrative data

Description of key information

The acute oral and dermal toxicity tests (according to OECD TG 401 and 402) were well investigated by Allen in 1997. The results indicated the test material has very low oral and dermal toxicity in rats. OECD TG 401 was deleted in 2002 due to animal welfare reasons, however, the validity of the results which accomplished by TG 401 should be confirmed. While, according to the nature of the substance and the likely route of human exposure routes, the acute inhalation toxicity study might not be considered. 
These two studies were utilized as key studies in substance acute toxicity evaluation due to their high adequacy, reliability and relevance to this element.
The following information is taken into account for any hazard / risk assessment:
Oral: LD50: > 2,000 mg/kg for rat (limit test) (OECD TG 401)
Dermal: LD50: > 2,000 mg/kg for rat (limit test) (OECD TG 402)
Value used for CSA:
LD50 (oral): 2,000 mg/kg bw
LD50 (dermal): 2,000 mg/kg bw
Justification for classification or non classification
According to the existing results on acute oral and dermal toxicity tests (LD50 > 2,000 mg/kg bw) in rats, there is conclusive evidence that BDP does not require classification as set of risk phrases for these endpoints.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via dermal route

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

Additional information

Justification for classification or non-classification