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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: granular

Test animals

Species:
rabbit
Strain:
other: Local strain of albino rabbits; not further specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: local strain obtained from A. Loebenstein Laboratory Animals, Yoqneam
- Age at study initiation: no information
- Weight at study initiation: 2.1 to 2.7 grams
- Housing: individual aluminum cages
- Diet (e.g. ad libitum): Commercially available complete pelleted rabbit diet (Arnavit), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2 °C
- Humidity (%): 60% +/- 15%
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 14 hours light per day

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h
Observation period:
5, 24, 48 and 72 hours
Number of animals:
6
Details on study design:
Single doses (0.5 g) of the test material were placed on to unmedicated gauze patches (25 x 25 mm) and were applied to the skin test site. The patch was held in place by a porous dressing strip which was then kept in place by an adhesive bandage to ensure that the test material was in close contact with the skin. The use of impervious material and occlusive dressing was to maximize the dermal absorption of the test material by the skin.

TEST SITE
- Area of exposure: Dorsum between the limb girdles
- % coverage: 25 x 25 mm
- Type of wrap if used: unmedicated gauze patches applied to skin and held in place by a porous dressing strip and adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped using double-distilled water to remove excess test material
- Time after start of exposure: 4 hours

SCORING SYSTEM: Criteria of Draize (1959) was used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.16
Reversibility:
not fully reversible within: 24 h
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
One rabbit had a very slight erythema 5 and 24 hours after dosing.

Animal No. Type of Score at time after dosing
and sex response 5 hrs 24 hrs 48 hrs 72 hrs
------------------------------------------------------------------------------------------
1 male E/O a) 0,0 0,0 0,0 0,0
2 male E/O a) 1,0 1,0 0,0 0,0
3 male E/O a) 0,0 0,0 0,0 0,0
1 female E/O a) 0,0 0,0 0,0 0,0
2 female E/O a) 0,0 0,0 0,0 0,0
3 female E/O a) 0,0 0,0 0,0 0,0
a) E/O: Erythema/Oedema (respectively)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, Tribromophenol is assessed as being a non-irritant material to the rabbit skin.