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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:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to international guidelines and GLPs by an experienced contract laboratory using the comercial product as test material and published in the peer reviewed literature.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Prenatal oral (gavage) developmental toxicity study of decabromodiphenyl oxide in rats.
Author:
Hardy et al.
Year:
2002
Bibliographic source:
Int J Toxicol 21:83–91.
Reference Type:
publication
Title:
Toxicololgy 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:
study report
Title:
Unnamed
Year:
2000
Reference Type:
publication
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
Deviations:
no
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
GD 0-19
Frequency of treatment:
once daily
Duration of test:
see below
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw/d
Basis:
nominal conc.
No. of animals per sex per dose:
25F/dose
Control animals:
yes, concurrent vehicle

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOEL
Effect level:
>= 1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: other:

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The no-observed-effect level (NOEL) for maternal and developmental toxicity was 1000 mg/kg-day, the highest dose level tested.
Executive summary:

To evaluate developmental exposures to commercial DecaBDE products (97.34% BDE-209, 2.66% nona- and octaBDE congeners), Hardy et al. (2002) conducted a guideline compliant developmental toxicity study performed in accordance with good laboratory practice (GLP) standards. In this study, female Sprague-Dawley rats (25 mated females/group) received 0, 100, 300, or 1000 mg /kg-day via gavage in corn oil on gestation days 0–19. All dams survived until scheduled sacrifice. No clinical signs of toxicity were observed. Pregnancy rates in the control and treated groups ranged from 96% to 100% and provided 23 or more litters in each group for evaluation on gestation day 20. No effect of treatment was detected in maternal gestational parameters (body

weight, body weight gain, and food consumption), uterine implantation data, liver weight, or necropsy findings.

Likewise, no treatment-related effects were detected in fetal body weights, fetal sex distribution, or from the fetal

external, visceral, or skeletal examinations. The no-observed-effect level (NOEL) for maternal and developmental

toxicity was 1000 mg/kg-day, the highest dose level tested (Hardy, 2002).