Prenatal developmental toxicity of decabromodiphenyl ethane in the rat and rabbit.
BACKGROUND
The potential embryotoxic and teratogenic effects of decabromodiphenyl ethane (DBDPEthane; CASRN 84852-53-9) were evaluated in prenatal developmental studies using rats and rabbits and performed in accordance with international guidelines and Good Laboratory Practice standards. Preliminary dose-range-finding studies were conducted, which indicated doses up to 1,250 mg/kg-day were well tolerated by both rats and rabbits.


METHODS
For the developmental studies, animals were administered DBDPEthane via gavage at dosage levels of 0, 125, 400, or 1,250 mg/kg-day from gestation day (GD) 6 through 15 for rats and GDs 6 through 18 for rabbits. All female rats and rabbits were sacrificed on GD 20 or GD 29, respectively, and subjected to cesarean section. Fetuses were individually weighed, sexed, and examined for external, visceral and skeletal abnormalities.


RESULTS
No treatment-related mortality, abortions, or clinical signs of toxicity were observed during the study. Body weights, body weight gain, and food consumption were not affected by treatment. No significant internal abnormalities were observed in either species on necropsy. Cesarean section parameters were comparable between control and treated groups. No treatment-induced malformations or developmental variations occurred.


CONCLUSIONS
Based on these results, no evidence of maternal toxicity, developmental toxicity, or teratogenicity was observed in rats or rabbits treated with DBDPEthane at dosage levels up to 1,250 mg/kg-day.
Hardy
Marcia L
ML
Albemarle Corporation, Baton Rouge, Louisiana 70801, USA. marcia.hardy@albemarle.com <marcia.hardy@albemarle.com>
Mercieca
Michael D
MD
Rodwell
Dean E
DE
Stedeford
Todd
T
D000014:Abnormalities, Drug-Induced; D000284:Administration, Oral; D000818:Animals; D001969:Bromobenzenes / Q000145:classification / Q000633:toxicity*; D004622:Embryo, Mammalian / Q000187:drug effects* / Q000196:embryology; D047108:Embryonic Development / Q000187:drug effects*; D005260:Female; D047109:Fetal Development / Q000187:drug effects*; D005411:Flame Retardants / Q000145:classification / Q000633:toxicity*; D018811:Maternal Exposure; D019055:No-Observed-Adverse-Effect Level; D011247:Pregnancy; D011817:Rabbits; D051381:Rats; D017207:Rats, Sprague-Dawley; D013723:Teratogens / Q000145:classification / Q000633:toxicity*
D001969:Bromobenzenes; D005411:Flame Retardants; D013723:Teratogens; C491509:decabromodiphenyl ethane