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Administrative data

Description of key information

TBPA: 28 D rabbit dermal; 21 D rat inhalation
TCPA (tetrachlorophthalic anhydride): 13 Wk rat gavage, 13 WK mouse gavage

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
LOAEL
94 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
2 000 mg/m³
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subchronic
Species:
rabbit

Additional information

TBPA has been tested in a 28 day rabbit dermal and 21 day rat inhalation studies. In the inhalation study, no adverse effects were noted at 2 mg/L. In the dermal study, all rabbits at the top dose of 5000 mg/kg died or were sacrificed prior to the study's end. The NOAEL for systemic toxicity in that study was the next highest dose, 500 mg/kg. Hisptopathlogy was not performed at the 5000 mg/kg dose, and limited clinical pathology indicated an increase in BUN, and albumin and glucose in the urine. These changes are indicative of an effect on the kidney. TBPA's structural analog, tetrachlorophthalic anhydride or TCPA, has been tested in the rat and mouse in 13 week studies with administration via gavage. Mice were not affected by doses up to 1500 mg/kg. Rats, however, were affected and the LOAEL was 94 mg/kg. Although no clinical pathology changes clearly associated with treatment were observed, rats exhibitied dose-dependent increases in kidney weights and in the incidence and severity of renal tuble necrosis and/or dilation. Thus, TCPA and TBPA appear to be renal toxicants in the rat and rabbit, respectively. Mice, however, appear resistent.


Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys

Repeated dose toxicity: dermal - systemic effects (target organ) urogenital: kidneys

Justification for classification or non-classification