Registration Dossier

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

Referenceopen allclose all

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:
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

Reference
Name:
Unnamed
Type:
Constituent

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.