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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
750 mg/kg bw/day
Additional information

Data for this endpoint was read across from BADGE. The read across to BPFDGE from BADGE (CAS#1675-45-3, EC#216-823-5) is appropriate for this endpoint as there are many study results, including phys/chem, ecotoxicology and mammalian toxicology, that indicate similar characteristics.

Administration of DGEBPA to adult rats by oral gavage at dose levels which represent extremely large multiples of potential human exposures resulted in only slight toxicity. Among adult males, body weights were decreased approximately 8 -1l% at dose levels of 540 and 750 mg/ kg/day in both the P1 and P2 generations, although there was not a statistically significant decrease in the body weights of the P1 males treated with 750 mg/kg/day until test day 238 {i.e., termination). In females, body weights were also affected in both generations. but only at the highest dose level (750 mg/ kg/day). Secondary changes in absolute and/or relative liver and kidney weights were also observed in these dose groups. There were no treatment-related effects on body weights among males given 50 mg/kg/day, or among females given 540 or 50 mg/kg/day in either generation. There were no treatment-related histological changes noted in any dose group. The NOAEL for adult males and females was considered to be 540 mg/kg/day, and the NOAEL for reproductive effects was 750 mg/kg/day.

Short description of key information:
Data for this endpoint was read across from BADGE. The read across to BPFDGE from BADGE (CAS#1675-45-3, EC#216-823-5) is appropriate for this endpoint as there are many study results, including phys/chem, ecotoxicology and mammalian toxicology, that indicate similar characteristics. BADGE displayed no indications of any adverse effects on reproduction in rats over two generations at dose levels which greatly exceed potential human exposure levels. The NOAEL for adult males and females was considered to be 540 mg/kg/day, and the NOAEL for reproductive effects was 750 mg/kg/day.

Effects on developmental toxicity

Description of key information
Data for this endpoint was read across from BADGE.  The read across to BPFDGE from BADGE (CAS#1675-45-3, EC#216-823-5) is appropriate for this endpoint as there are many study results, including phys/chem, ecotoxicology and mammalian toxicology, that indicate similar characteristics. There was no evidence of developmental toxicity at doses levels resulting in maternal toxicity in rabbits following oral administration or rabbits following dermal administration of BADGE.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
180 mg/kg bw/day
Effect on developmental toxicity: via dermal route
Dose descriptor:
NOAEL
300 mg/kg bw/day
Additional information

Data for this endpoint was read across from BADGE. The read across to BPFDGE from BADGE (CAS#1675-45-3, EC#216-823-5) is appropriate for this endpoint as there are many study results, including phys/chem, ecotoxicology and mammalian toxicology, that indicate similar characteristics.

Rabbit and rat developmental toxicity studies have been conducted via the oral route. Oral administration of TK 10490 to rabbits during days 7 to 19 of gestation produced evidence of maternal toxicity at 180 mg/kg/day in terms of anorexia and an initial weight loss. Treatment at 60 and 20 mg/kg/day was not associated with any maternal toxicity. There was no evidence that treatment of the dam with TK 10490 adversely affected mean litter parameters. Embryofoetal development and morphology was unaffected at all the dosages investigated. Rats dosed on days 6 to 15 of gestation had evidence of maternal toxicity at 540 mg/kg/day with slightly retarded mean body weight gain. A physiological change (increase in post-dosing salivation) which is not necessarily indicative of a toxic response per se was recorded at the high and intermediate dosages but there was no evidence that treatment of the dam had any adverse effect on embryofoetal development or morphology at any of the dosages investigated.

Dermal exposure of pregnant rabbits to 0, 30, 100 or 300 mg DGEBPA/kg body weight/day on gestation days 6 through 18 produced no evidence of embryo/fetal toxicity or teratogenicity resulting in a embryo/fetal no observed effect level (NOEL) of 300 mg/kg body weight/day. Exposure to 300 mg DGEBPA/kg body weight/day produced maternal toxicity as evidenced by moderate to severe erythema, fissures, hemorrhages and slight edema at the site of exposure. Similar, but less severe skin lesions were observed in pregnant rabbits in the 100 mg/kg/day exposure group. Exposure to 30 mg DGEBPA/kg body weight/day produced slight erythema (barely perceptible) which was not considered toxicologically significant.

Justification for classification or non-classification