Registration Dossier

Administrative data

Description of key information

Six studies are available for the acute oral toxicity endpoint:
Acute toxicity: oral.001 - LD50 (male mouse): >7000 mg/kg bw
Acute toxicity: oral.002 - LD50 (mouse): >10000 mg/kg bw
Acute toxicity: oral.003 - LD50 (rat): >5000 mg/kg bw
Acute toxicity: oral.004 - LD50 (rat): >50 mg/kg bw
Acute toxicity: oral.005 - LD50 (male rat): >10000 mg/kg bw
Acute toxicity: oral.006 - LD50 (rat): >50000 mg/kg bw
Two studies are available for the acute inhalation toxicity endpoint:
Acute toxicity: inhalation.001 - 1h-LC50 (rat): > 57 mg/L air
Acute toxicity: inhalation.002 - 8h-LC50 (rat)> 0.5 mg/L air
- 8h-LC50 (mouse)> 0.5 mg/L air
- 8h-LC50 (guinea pig)> 0.5 mg/L air
Three studies are available for the acute dermal toxicity endpoint:
Acute toxicity: dermal.001 - LD50 (rabbit): >2 g/kg bw
Acute toxicity: dermal.002 - LD50 (rabbit)> 10 g/kg bw
Acute toxicity: dermal.003 - LD50 (rabbit): >200 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
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
57 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
10 000 mg/kg bw

Additional information

Tetrabromobisphenol A was not acutely toxic by the oral, dermal or inhalation routes. The rat oral LD50 > 5000 mg/kg bw. The rabbit dermal LD50 was > 2000 mg/kg bw. The inhalation LC50 in the rat was > 57 mg/L for a 1 h exposure and >0.5 mg/L (the only concentraiton tested) for an 8 h exposure in rats, mice and guinea pigs.

Justification for classification or non-classification

Based upon the high LD50 values for oral and dermal exposure, together with high supporting LC50 values for inhalation exposure and the absence of other major significant effects, TBBPA does not need to be classified for acute toxicity according to Directive 67/548/EEC or Regulation (EC) No 1272/2008.