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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline standards with acceptable restrictions - analytical purity of the test substance not indicated

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
other: Federal Register, 38, No.187 §1500.41
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(14/10 hour dark/light rhythm, treatment on intact and abraded skin, occlusive treatment, 24 hour long treatment)
Principles of method if other than guideline:
Draize test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name as cited in publication: 2 - [2' hydroxy - 3', 5' - bis- (alpha, aplha dimethylbenzyl) phenyl]-benzotriazole
- Batch number: A 16-234/5
- Analytical purity: no data
- Physical state: solid

Specific details on test material used for the study:
- Analytical purity: no data
- Batch No.: A 16-234/5
- pH: 6

Test animals

Species:
rabbit
Strain:
other: Himalayan breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Weight at study initiation: 1.5 - 2 kg.
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit food (NAFAG Gossau SG)
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 14/10

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved (unabraded and abraded)
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated parts of the same rabbit
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
7 days
- Scoring of skin irritation was performed 24 and 72 hours after initiation of treatment.
Number of animals:
6
Details on study design:
TEST SITE
- Before treatment the entire back, and the flank of the rabbits were shaved and immediately before treatment, the shaven skin of the left side was slightly scarified. The right side was not scarified.
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The patches were covered with an impermeable material and fastened with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: 24 hours

SCORING SYSTEM: draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(unabraded skin)
Basis:
mean
Remarks:
(of all 6 animals)
Time point:
other: mean over 24, 48 and 72 hours after start of treatment
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Remarks:
(unabraded skin)
Basis:
mean
Remarks:
(of all 6 animals)
Time point:
other: mean over 24, 48 and 72 hours after start of treatment
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
Effects on scarified skin 24 hours after start of exposure (6 animals)
- Erythema: 1 (animals # 1, 3, 5 and 6), 0 (animals # 2 and 4)
- Oedema: 0 (all animals)

Effects on scarified skin 48 hours after start of exposure (6 animals)
- Erythema: 1 (animal # 6), 0 (animals # 1 - 5)
- Oedema: 0 (all animals)

Effects on scarified skin 72 hours after start of exposure (6 animals)
- Erythema: 0 (all animals)
- Oedema: 0 (all animals)

Any other information on results incl. tables

In accordance with conventional practice, only results of the non scarified skin sections are adopted in the final assessment for skin irritation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met