Registration Dossier

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

Referenceopen allclose all

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 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 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

Reference
Name:
Unnamed
Type:
Constituent
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).