Bis(pentabromophenyl) ether

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed prior to international guidelines and GLP.

Data source

Reference

Reference 1

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 2

Reference Type:

study report

Title:

Unnamed

Year:

1978

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Test conducted prior to international guidelines. However, performance was consistent with today's guidelines.

GLP compliance:

no

Test type:

standard acute method

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

see below

Doses:

see below

No. of animals per sex per dose:

see below

Control animals:

no

Results and discussion

Preliminary study:

see below

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 8 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

see below

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The acute toxicity of DecaBDE (purity not stated) was evaluated in New Zealand white rabbits using groups of 6 (3 males and 3 females) with dose levels of 0.5, 2.0, 5.0, and 8.0 g/kg. The limit dose was the highest possible due to mechanical and physical limitations. A single dose was applied to the clipped backs, under occlusion to an area over 10% of the body surface. Prior to application of the test article, the skin was abraded on 2 males and 1 female rabbit. The test article was applied to intact skin on the remainder of the animals. After 24 h, the occlusion was removed and the test article cleared from the skin. Animals were monitored for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 h post dosage, and daily for the remainder of the 14-day observation period. No test article related toxicity was observed. Though designed as a LD50 11 experiment, DecaBDE’s physical and chemical properties preclude it from being a hazard via the dermal route of exposure.

Executive summary:

The acute toxicity of DecaBDE (purity not stated) was evaluated in New Zealand white rabbits using groups of 6 (3 males and 3 females) with dose levels of 0.5, 2.0, 5.0, and 8.0 g/kg. The limit dose was the highest possible due to mechanical and physical limitations. A single dose was applied to the clipped backs, under occlusion to an area over 10% of the body surface. Prior to application of the test article, the skin was abraded on 2 males and 1 female rabbit. The test article was applied to intact skin on the remainder of the animals. After 24 h, the occlusion was removed and the test article cleared from the skin. Animals were monitored for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 h post dosage, and daily for the remainder of the 14-day observation period. No test article related toxicity was observed. Though designed as a LD50 11 experiment, DecaBDE’s physical and chemical properties preclude it from being a hazard via the dermal route of exposure.