Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Approximately 1973-1974
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed using human volunteers, and therefore directly applicable to humans.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Toxicological and environmental factors involved in the selection of decabromodiphenyl oxide as a fire retardant chemical.
Author:
Norris et al.
Year:
1974
Bibliographic source:
FF/Combust Toxicol 1:52–77.
Reference Type:
publication
Title:
Toxicology of octabromobiphenyl and decabromodiphenyl oxide.
Author:
Norris et al.
Year:
1975
Bibliographic source:
Environ Health Perspectives 11:153-161.
Reference Type:
study report
Title:
Unnamed
Year:
1975
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.

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
See below.
GLP compliance:
not specified
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Former commercial product FR-BA-300 composed of 77% BDE209, 22% Nonabromodiphenyl Ethers, and 0.8% Octabromodiphenyl ethers.

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: See below
Vehicle:
other: See below
Concentration / amount:
See below
Challengeopen allclose all
Route:
other: See below
Vehicle:
other: See below
Concentration / amount:
See below
No. of animals per dose:
See below
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: see below
Group:
other: see below
Dose level:
see below
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
see below
Remarks on result:
other: Reading:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Did not induce skin sensitization.
Executive summary:

In 50 human subjects, repeated application of a suspension of a 5% commercial product (purity not stated) in petrolatum 3 times a week for 3 weeks and challenged 2 weeks subsequent to the last induction application did not result in skin sensitisation (Norris et al., 1974, 1975).

Additionally, human volunteers (80 males and 120 females) were treated with 9 induction patches using 2 batches of a commercial product. The first sample was evaluated as received, and the second as a 2% (w/v) aqueous suspension. The patches were applied once every Monday, Wednesday, and Thursday, allowed to contact the skin for 24 h, and the skin was graded for irritation. Fifteen

subjects among the 200 volunteers showed some slight irritation reactions: very slight erythema (barely perceptible) in 14/1800 patches, mild (well-defined) erythema in 2/1800 patches, and very slight edema (barely perceptible) in 1/1800 patches. After a nonpatching period of 12 days, the challenge patch was applied to detect sensitization. No evidence of skin sensitisation with either of the test materials in any of the subjects tested was observed (IBTL, 1975).