Bis(pentabromophenyl) ether

Genetic toxicity: in vivo

Administrative data

Endpoint:

genetic toxicity in vivo

Remarks:

Type of genotoxicity: other: bone marrow cytogenetics

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Performed prior to international guidelines. Accepted under the EURAR.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Toxicology of octabromobiphenyl and decabromodiphenyl oxide.

Author:

Norris et al.

Year:

1975

Bibliographic source:

Environ Health Perspect 11:153–161.

Reference 2

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 3

Reference Type:

publication

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Bone marrow of parents and offspring in a one generation reproduction test examined for evidence of cytogenetic effects.

GLP compliance:

no

Type of assay:

other: cytogenetics

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

Details on test material:

Former commercial product FR BA300 used. Composed of ~77% BDE 209, ~ 22% NonaBDEs and 0.8% OctaBDEs.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: feed

Duration of treatment / exposure:

see 7.8.1

Frequency of treatment:

see 7.8.1

Post exposure period:

see 7.8.1

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 3, 30, 100 mg/kg bw/d
Basis:
actual ingested

No. of animals per sex per dose:

see 7.8.1

Control animals:

yes, concurrent vehicle

Examinations

Tissues and cell types examined:

bone marrow

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

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 did not alter bone marrow cytogenetics.

Executive summary:

No cytogenic changes were observed in the bone marrow of rats (parents and offspring) undergoing a one-generation reproduction test using FR-300-BA at the highest dose tested, 100 mg/kg bw/d (Norris et al., 1975).