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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
Study period:
Aug - Sept 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported guideline conform study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

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

Test animals

Species:
rabbit
Strain:
other: HC:NWZ
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3500 g
- Housing: Animals were housed individually
- Diet: ssniff K, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Not required, the untreated sites of the same animal served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g test substance, moistened with water
Duration of treatment / exposure:
4 h
Observation period:
7 d
reading time points: 1, 24, 48, 72 h and 7 d
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm² on the back of the animal
- Type of wrap if used: The test substance was applied to a gauze patch, held in place by elastic tape that was permeable to air.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin sites were washed with water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: mean of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effect
Irritation parameter:
edema score
Basis:
other: mean of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effect
Irritant / corrosive response data:
Dermal application of the test substance did not result in erythema or edema in any of the animals tested at any observation time point.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, when evaluated for primary skin irritation by a 4-hour patch test conducted on intact skin, was found to be not irritating.
Executive summary:

The test material, when evaluated for primary skin irritation by a 4-hour patch test conducted on intact skin, was found to be not irritating.