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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 study with acceptable restrictions (limited documentation, no data on test substance purity, occlusive conditions, 24 h exposure)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation, occlusive treatment, 24 h exposure, no scoring at 48 h))
Principles of method if other than guideline:
6 rabbits were treated with 0.5 g of the test substance, prepared as paste with diethyl succinate, for 24 h under occlusive conditions. The test sites were shaved before treatment. The test substance was applied to intact as well as to abraded skin. Scoring was recorded 24 h and 72 h after application (Draize Test).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: diethyl succinate
Controls:
other: untreated site served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:
24 h
Observation period:
no data
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: no data
- Type of wrap if used: impervious patch

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

SCORING SYSTEM: according to the Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: intact and abraded skin

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU