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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6/28/1991 to 6/23/1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to international and GLP guidelines using the commercial product as test article and published in a peer-reviewed journal.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1992
Reference Type:
publication
Title:
Prenatal Developmental Toxicity of Decabromodiphenyl Ethane in the Rat and Rabbit
Author:
Hardy, M; Mercieca, M; Rodwell, D; Stedeford, T
Year:
2010
Bibliographic source:
Birth Defects Research (Part B) 83:1-8 (2010)
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
no
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
See Hardy et al. 2010

96.3% Decabromodiphenyl ethane
3.6 % Dodecabromodiphenyl ethane

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on test animals and environmental conditions:
See Hardy et al. 2010

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
See Hardy et al. 2010
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
See Hardy et al. 2010
Details on mating procedure:
See Hardy et al. 2010
Duration of treatment / exposure:
GD 6-15
Frequency of treatment:
Once daily, 7 days/wk
Duration of test:
See Hardy et al. 2010
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
125 mg/kg bw/day (nominal)
Dose / conc.:
400 mg/kg bw/day (nominal)
Dose / conc.:
1 250 mg/kg bw/day (nominal)
No. of animals per sex per dose:
25 females/dose
Control animals:
yes, concurrent vehicle
Details on study design:
See Hardy et al. 2010

Examinations

Maternal examinations:
See Hardy et al. 2010
Ovaries and uterine content:
See Hardy et al. 2010
Fetal examinations:
See Hardy et al. 2010
Statistics:
See Hardy et al. 2010
Indices:
See Hardy et al. 2010
Historical control data:
See Hardy et al. 2010

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
effects observed, treatment-related
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Other effects:
effects observed, non-treatment-related
Description (incidence and severity):
Incidental gross lesions.

Maternal developmental toxicity

Number of abortions:
no effects observed
Pre- and post-implantation loss:
no effects observed
Total litter losses by resorption:
no effects observed
Early or late resorptions:
no effects observed
Dead fetuses:
no effects observed
Changes in pregnancy duration:
no effects observed
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed
Changes in number of pregnant:
no effects observed
Other effects:
no effects observed
Details on maternal toxic effects:
Maternal toxic effects:no effects

Effect levels (maternal animals)

Key result
Dose descriptor:
NOAEL
Effect level:
1 250 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: effect type not specified
Remarks on result:
other: Based on maternal body weights, weight gain, food consumption, necropsy observations, signs of toxicity, mortality.

Maternal abnormalities

Key result
Abnormalities:
no effects observed
Localisation:
other: No effects
Description (incidence and severity):
No treatment-related malformations or developmental variation were observed.

Results (fetuses)

Fetal body weight changes:
no effects observed
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Reduction in number of live offspring:
no effects observed
Changes in sex ratio:
no effects observed
Changes in litter size and weights:
no effects observed
Changes in postnatal survival:
no effects observed
External malformations:
no effects observed
Skeletal malformations:
effects observed, non-treatment-related
Description (incidence and severity):
Statistical increases were noted in the number of litters with hyoid unossified and reduced ossification of the skull at the 400 mg/kg/d level. Since similar increases were not observed at the 1250 mg/kg/d level, the differences at the 400 mg/kg/d level were not considered to be biologically meaningful.
Visceral malformations:
no effects observed
Other effects:
no effects observed
Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Key result
Dose descriptor:
NOAEL
Effect level:
>= 1 250 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
reduction in number of live offspring
changes in sex ratio
fetal/pup body weight changes
changes in litter size and weights
changes in postnatal survival
external malformations
skeletal malformations
visceral malformations

Fetal abnormalities

Key result
Abnormalities:
no effects observed
Localisation:
other: No effects noted.

Overall developmental toxicity

Key result
Developmental effects observed:
no
Lowest effective dose / conc.:
1 250 mg/kg bw/day (nominal)
Treatment related:
no
Relation to maternal toxicity:
not specified
Dose response relationship:
no
Relevant for humans:
no

Any other information on results incl. tables

See Hardy et al. 2010

Applicant's summary and conclusion

Conclusions:
Decabromodiphenyl ethane did not induce developmental effects in rats at doses up to 1250 mg/kg/d administered prenatally.
Executive summary:

Decabromodiphenyl ethane did not induce developmental effects in rats at doses up to 1250 mg/kg/d administered prenatally.