Bis(pentabromophenyl) ether

Developmental toxicity / teratogenicity

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

Reference

Reference 1

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 2

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 3

Reference Type:

study report

Title:

Unnamed

Year:

2000

Reference 4

Reference Type:

publication

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 83-3 (Prenatal Developmental Toxicity Study)

Deviations:

no

GLP compliance:

yes

Limit test:

no

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

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).