Registration Dossier

Administrative data

Description of key information

LD50 (oral, rat) > 3000 mg/kg bw

LC0 (inhalation, rat, 1h) = 22.53 mg/L

LD50 (dermal, rabbit) = 5000 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:
3 000 mg/kg bw
Quality of whole database:
The key study was performed on DBHP and confirmed by the result from four other supporting studies that were performed on similar substances.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
22 530 mg/m³
Quality of whole database:
No adverse effect level up to 22.53 mg/L.
The key study was performed on DBHP and confirmed by the result from three other supporting studies that were performed on similar substances.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
No effect level: 4000 mg/kg. The key study was performed on DBHP and confirmed by the result from two other supporting studies that were performed on similar substances.

Additional information

There is no evidence of adverse effects of DBHP when administered to animals at dose above 2000 mg/kg bw following all routes of exposure. The oral administration shows a clinical sings at dose above 2150 mg/kg bw; for other routes of exposure there are no sings of toxicity for dosages of greater than 4000 mg/kg bw.

Justification for classification or non-classification

There is no evidence of adverse effects of DBHP when administered to animals following oral, inhalation or dermal routes of exposure, therefore, it can be assumed that:

No classification for acute oral toxicity is warranted under CLP Regulation (EC) no. 1272/2008;

No classification for acute inhalation toxicity is warranted under CLP Regulation (EC) no. 1272/2008;

No classification for acute dermal toxicity is warranted under CLP Regulation (EC) no. 1272/2008.