Bis(pentabromophenyl) ether

Genetic toxicity: in vitro

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

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1986

Reference 2

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 3

Reference Type:

study report

Title:

Unnamed

Year:

1998

Reference 4

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 5

Reference Type:

publication

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

no

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 479 (Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells)

Deviations:

no

Test guideline 4

Qualifier:

equivalent or similar to guideline

Principles of method if other than guideline:

see below.

GLP compliance:

yes

Type of assay:

other: see above

Test material

Test material information

Constituent 1

Reference substance name:

Bis(pentabromophenyl) ether

EC Number:

214-604-9

EC Name:

Bis(pentabromophenyl) ether

Cas Number:

1163-19-5

Molecular formula:

C12Br10O

IUPAC Name:

bis(pentabromophenyl) ether

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)