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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
genetic toxicity in vitro
Remarks:
Type of genotoxicity: other: gene mutation, chromosome aberration, sister chromatid exchange, mouse lymphoma
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Studies performed by the U.S. National Toxicology Program and/or experienced contract laboratories, and included in the EUR 20402 EN..

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1986
Reference Type:
publication
Title:
Responses of the L5178Y tk+/tk− mouse lymphoma cell forward mutation assay: III. 72 coded chemicals.
Author:
McGregor et al.
Year:
1988
Bibliographic source:
Environ Mol Mutagen 12:85–154. Erratum in: Environ Mol Mutagen (1988) 12:345.
Reference Type:
study report
Title:
Unnamed
Year:
1998
Reference Type:
publication
Title:
Toxicology and human health assessment of decabromodiphenyl ether
Author:
Hardy et al.
Year:
2009
Bibliographic source:
Critical Reviews in Toxicology 39(S3):1-44
Reference Type:
publication
Title:
Unnamed
Year:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 479 (Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells)
Deviations:
no
Qualifier:
equivalent or similar to
Principles of method if other than guideline:
see below.
GLP compliance:
yes
Type of assay:
other: see above

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
see below
Species / strain
Species / strain / cell type:
other: see EURAR
Details on mammalian cell type (if applicable):
See EURAR
Test concentrations with justification for top dose:
See EURAR
Vehicle / solvent:
See EURAR
Controls
Remarks:
See EURAR

Results and discussion

Test results
Species / strain:
other: all tests
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

DecaBDE is not genetically active.
Executive summary:

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)