Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
other: rat and rabbit
Quality of whole database:
The 90-d study was conducted prior to development of international guidelines. The lack of effects observed in the study is consistent with expectations and with the 2 modern prenatal developmental studies.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information
Justification for selection of Effect on fertility via oral route:
Two (rat, rabbit) prenatal developmental studies plus a 90 d study in rats show no evidence of effect on the reproductive system. The NOEL in the prenatal studies was 1000 mg/kg/d, the highest dose, administered during gestation. The NOEL in the 90 d study was 1% in the diet, the highest dose administered. EBTBP is expected to be poorly absorbed after oral administration based on its high molecular weight, large molecular volume, folded molecular configuraiton, and negligible solubility in both aqueous and organic solvent. The majority of an oral dose is expected to be eliminated in the feces without prior absorption or metabolism.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
other: rat and rabbit
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information
Justification for selection of Effect on developmental toxicity: via inhalation route:
EBTBP is not expected to be absorbed from the respiratory tract to any significant extent due to its large molecular size, molecular configuration, and insolubility in aqueous and organic solvents, including lipids.

Justification for selection of Effect on developmental toxicity: via dermal route:
EBTBP is not expected to be absorbed dermally to any significant extent due to its large molecular size, molecular configuration, and insolubility in aqueous and organic solvents, including lipids.

Justification for classification or non-classification

Two (rat, rabbit) prenatal developmental studies plus a 90 d study in rats show no evidence of effect on the reproductive system. The NOEL in the prenatal studies was 1000 mg/kg/d, the highest dose, administered during gestation. The NOEL in the 90 d study was 1% in the diet, the highest dose administered. EBTBP is expected to be poorly absorbed after oral administration based on its high molecular weight, large molecular volume, folded molecular configuraiton, and negligible solubility in both aqueous and organic solvent. The majority of an oral dose is expected to be eliminated in the feces without prior absorption or metabolism.