Bis(pentabromophenyl) ether

Skin sensitisation

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

Reference

Reference 1

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 2

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 3

Reference Type:

study report

Title:

Unnamed

Year:

1975

Reference 4

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

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

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)

Induction

Induction 1

Route:

other: See below

Vehicle:

other: See below

Induction 2

Concentration / amount:

See below

Challenge

Challenge 1

Route:

other: See below

Vehicle:

other: See below

Challenge 2

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: other: see below. Group: other: see below. Dose level: see below. No with. + reactions: 0.0. Total no. in groups: 50.0. Clinical observations: see below.

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).