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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
only a 50% aqueous substance preparation was tested.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Weißer Wiener
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: average weight 3.0 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and damaged skin
Vehicle:
water
Controls:
no
Amount / concentration applied:
The test substance was given as a 50% aqueous preparation. The amount applied is not specified.
Duration of treatment / exposure:
not specified
Observation period:
8 days
Number of animals:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: on the first day after instillation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Remarks on result:
other: Determination of erythema was not possible at 24 and 72 hours.
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
damaged skin
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Remarks on result:
other: Determination of erythema was not possible at 24 and 72 hours.
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
24/48/72 h
Score:
0.55
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
The test item was found to have no irritation potential, however the exact determination of erythema scores at 24, 48 and 72 hours (except animal #1 intact skin) was not possible due to coloring by the test substance. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Foi. Cosm. Tox. 13, 355, 1975). The test item was found to cause no irritation when applied to intact rabbit skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance did not induce adverse effects to the skin and thus, was found to be not irritating to skin.