Registration Dossier
Registration Dossier
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EC number: 214-604-9 | CAS number: 1163-19-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The comercial DecaBDE product did not induce maternal or fetal toxicity at doses up to 1000 mg/kg/d in rats administered the material in corn oil from GD0 -19 (NOEL = 1000 mg/kg bw/d). The commercial DecaBDE product did not induce developmental neurotoxicity in rats exposed in utero and via lactation through post-natal day 21 (NOAEL = 1000 mg/kg bw/d). No effects on the reproductive system were observed in male or female rats and mice when the commercial DecaBDE product was administered for a lifetime (e.g. two years) at doses up to 5% of the diet. Similarly, no effects on the reproductive system were observed in male or female rats and mice at doses up to 5% of the diet for 90 d. A one-generation reproduction study in rats using the former commercial product FR 300BA (~77% BDE 209, ~22% NonaBDEs and 0.8% OctaBDEs) indicated no effects on fertility at doses up to 100 mg/kg bw/d administered in the diet prior to and during mating, gestation, and development.
Short description of key information:
90 D, 13 Wk, 2 year studies in rats and mice. Rat prenatal developmental, Rat developmental neurotoxicity.
Effects on developmental toxicity
Description of key information
Prenatal developmental and developmental neurotoxicity studies.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The rat oral NOEL from a guideline- and GLP compliant prenatal developmental study was 1000 mg/kg bw/d, the highest dose tested, administered from gestation day 0 - 19. The rat oral NOAEL from a guideline- and GLP-compliant developmental neurotoxicity study was 1000 mg/kg bw/d administered to maternal animals from gestation day 6 through lactation day 21. See Hardy et al. 2009 (Critical Reviews in Toxicology 39(S2):1 -44) additional discussion.
Justification for classification or non-classification
DecaBDE is not a reproductive or developmental toxicant at doses up to, and exceeding, 1000 mg/kg bw/d. See Hardy et al. (Critical Reviews in Toxicology 39 (S3):1 -44) for a discussion.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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