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
Additional information
No evidence of a genotoxic effect was detected in the Ames Salmonella, chromosome aberration, mouse lymphoma, or sister-chromatid exchange tests (McGregor et al., 1988; NTP, 1986; Wagner & Klug, 1998). No cytogenic changes were observed in the bone marrow of rats (parents and offspring) undergoing a one-generation reproduction test using FR-300-BA (Norris et al., 1975).
Test system |
Cell/strain; assay |
Result (+S9/-S9) |
Reference |
Bacteria |
|||
S. typhimurium |
TA98, 100, 1535, 1537; reverse mutation |
-/- |
Wagner and Kling (1998) (a) |
-/- |
NTP (1986) |
||
E. coli |
WP2 uvrA; reverse mutation |
-/- |
Wagner and Kling (1998) |
Mammalian cellsin vitro |
|||
Mouse lymphoma cells |
L5178Ytk+/tk-; forward mutation |
ND/- |
McGregor et al. (1988) |
Chinese hamster ovary cells |
Sister-chromatid exchange |
-/- |
NTP (1986) |
Chromosomal aberrations |
-/- |
NTP (1986) |
|
Mammalian cellsin vivo |
|||
Sprague Dawley rats |
Cytogenetic evaluation of bone marrow |
ND/- |
Norris et al. (1975) |
(a) Conducted in compliance with the US Food and Drug Administration’sGood Laboratory Practice for Nonclinical Laboratory Studies(FDA, 2002), the US EPA’sGood Laboratory Practice Standards(EPA, 1989, 1996), the United Kingdom’sGLP Compliance Programme, the Japanese GLP Standards, and the OECD’sPrinciples on Good Laboratory Practice(OECD, 1998).
ND = not determined.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
DecaBDE has been tested in a number of genetic toxicity tests: in vitro - Ames, Mouse lymphoma, Sister Chromatid Exchange, Chromosome Aberration, in vivo - Bone Marrow cytogenics. All studies showed an absence of genotoxicity.
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