Registration Dossier

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.