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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27th April - 5th June 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study; methodology was conducted according to generally accepted guidelines using the commercial product as test article.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981
Reference Type:
publication
Title:
RISK ASSESSMENT of 2,2’,6,6’-TETRABROMO-4,4’-ISOPROPYLIDENE DIPHENOL.
Author:
EU risk assessment: United Kingdom (TBBPA)
Year:
2008
Bibliographic source:
Environment Agency Chemicals Assessment Section United Kingdom
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Tetrabromo Bisphenol-A, Lot # R6/FD2, was dermally applied to ten guinea pigs for a total of nine six-hour insult periods. A positive control group consisting of 10 guinea pigs was treated with 2 -4 dinitrochlorobenzene.
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tetrabromo Bisphenol-A
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): see Fig. N/A
- Substance type: Monoconstituent
- Physical state: Solid, white powder
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components: Not reported
- Isomers composition: Not reported
- Purity test date: Not reported
- Lot/batch No.: #R6/FD2
- Expiration date of the lot/batch: Not reported
- Radiochemical purity (if radiolabelling): N/A
- Specific activity (if radiolabelling): N/A
- Locations of the label (if radiolabelling): N/A
- Expiration date of radiochemical substance (if radiolabelling): N/A
- Stability under test conditions: Stable; "there was no apparent change in thephysical state of the test article or control article during adminstration"
- Storage condition of test material: Not reported

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Inc, Douglassville, Penn. USA
- Age at study initiation: Not reported
- Weight at study initiation: 220 to 500 grams
- Housing: Two per cage, in stainless steel 1/2" wire mesh cages
- Diet (e.g. ad libitum): Wayne Guinea Pig Diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72F +/- 5F
- Humidity (%): Ambient
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 10 hours light: 14 hours dark

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Moistened with 80% ethanol
Concentration / amount:
500 mg per induction site
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Moistened with 80% ethanol
Concentration / amount:
500 mg per induction site
No. of animals per dose:
Ten
Details on study design:
RANGE FINDING TESTS: N/A

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: One
- Exposure period: Six hours
- Test groups: One group of 10
- Control group: one group of ten exposed to 2-4 dinitrochlorobenzene
- Site: Dorsal area
- Frequency of applications: See below
- Duration: a total of three weeks
- Concentrations: 500 mg/site

B. CHALLENGE EXPOSURE
- No. of exposures: Eight (not including intial exposure; rotated between application sites, giving a total of three exposures per site )
- Day(s) of challenge: Every Monday, Wednesday, and Friday for three weeks
- Exposure period: Six hours
- Test groups: 10 guinea pigs
- Control group: 10 guinea pigs exposed to 2-4 dinitrochlorobenzene
- Site: Dorsal area (split into three application sites, and dosed on a rotating basis)
- Concentrations: 500 mg/site
- Evaluation (hr after challenge): Treated sites examined 7, 24, and 48 hours after each exposure
Challenge controls:
2,4 dinitrochlorobenzene: 1%/mL/site
Positive control substance(s):
yes
Remarks:
2,4 dinitrochlorobenzene

Study design: in vivo (LLNA)

Vehicle:
other: Ethanol
Concentration:
LLNA not performed
No. of animals per dose:
LLNA not performed
Details on study design:
LLNA not performed
Statistics:
LLNA not performed

Results and discussion

Positive control results:
2,4 dinitrochlorobenzene elicited positive responses at challenges I and II

In vivo (non-LLNA)

Results
Reading:
rechallenge
Group:
test group
Dose level:
500 mg
No. with + reactions:
0
Remarks on result:
other: Reading: rechallenge. Group: test group. Dose level: 500 mg. No with. + reactions: 0.0.

Any other information on results incl. tables

Table 1: Average Scores at 7, 24, 48 hours following Challenge I and II

 

Challenge I

Challenge II

Site I

Site II

Site I

Site II

Test article

7

24

48

7

24

48

7

24

48

7

24

48

Tetrabromobisphenol-A (500 mg)

0

0

0

0

0

0

0

0

0

0

0

0

DNCB (1%)

1

1

1

1

1.5

1

1

1

1.2

1

1

2

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Tetrabromo Bisphenol-A, Lot #R6-FD2, did not cause delayed hypersensitivity in guinea pigs.
Executive summary:

Tetrabromobisphenol-A, Lot # R6/FD2, was dermally applied to ten guinea pigs for a total of nine six-hour insult periods. A positive control group consisting of 10 guinea pigs was treated with 2,4 dinitrochlorobenzene. Approximately fourteen days after the last senstizing exposure, the animals were challenged in the same manner at both the site of sensitizing and a second challenge site. 48 hours after the first challenge, a second challenge was made. A positive reposnse was elicited by the animals receiving 2,4 dinitrochlorobenzene at challenges I and II. Erythema was observed during induction at 7 hours post doses 3 and 9, 24 hours post doses 3, 6, and 9, and 48 hours post doses 3, 6, and 9. No irritation was observed during induction or challenge periods with Tetrabromo Bisphenol-A.

Tetrabromo Bisphenol-A, Lot # R6/FD2, did not cause delayed hypersensitivity in guinea pigs.