Registration Dossier

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:
other: OECD-Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: granules
Details on test material:
- Name of test material (as cited in study report): Benzotriazol
- Synonyms: Preventol CI8; Preventol CI8-100
- Substance type: pale yellow granules
- Physical state: solid
- Lot/batch No.: 909

Test animals

Species:
rabbit
Strain:
other: HC:NZW
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Interfauna UK Ltd

- Weight at study initiation: 3.0 - 3.7 kg
- Housing: standard single animal cages
- Diet: ssniff K 4 ad libitum
- Water: ad libitum
- Acclimation period: two weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +- 2 °C
- Humidity (%): 45 - 65%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
500 mg of substance
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, 72 hours, 7 and 14 days
Number of animals:
3
Details on study design:
according to guideline
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: elastic gluing dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
not irritating

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Benzotriazole is not classified as irritating to the skin of rabbits.