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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
Remarks:
.
Justification for type of information:
see read-acorss justification attached in chapter 13.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Solbrol A
- Physical state: solid
- Analytical purity: no data

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 males
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:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Reversibility:
other: reversibility: not applicable
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.
Other effects:
no data on body weight and clinical observations

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified