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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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Refer to section 'Principles of method if other than guideline'
Principles of method if other than guideline:
Deviation from OECD guideline 404:
- BASF-method, 20h exposure
- Occlusive type of coverage instead of semi-occlosive.
- Exposure period of 20 h instead of 4 hours.
- Observation period of 8 days instead of 14 days.
The named deviations from the OECD guideline 404 represents a tightening of the test conditions.
GLP compliance:
no

Test material

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

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.24 and 3.04 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Concentration: 50% solution
Duration of treatment / exposure:
20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: Back and ear of the rabbits
- % coverage: Back: 2.5 x 2.5 cm

OBSERVATION TIME POINTS: 24 hours and 8 days

SCORING SYSTEM:
- Method of calculation: Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal: #1 and #2
Time point:
other: 20 hours
Remarks on result:
no indication of irritation
Remarks:
red substance residues
Irritation parameter:
edema score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal: #1 and #2
Time point:
other: 20 hours
Remarks on result:
no indication of irritation
Remarks:
red substance residues

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test material is not considered to cause corrosion or irritation to the skin.
Executive summary:

An skin irritation potential of the test substance was investigated in an in vivo study performed equivalent to OECD guideline 404. A 50% solution of the test substance in water was applied to the shaved skin of two Vienna White rabbits. The test was performed under occlusive conditions for an exposure period of 20 hours. The skin was scored for signs of irritation after 24 hours and 8 days. Under the conditions of this test no indication of skin irritation was observed.
The performed skin irritation test showed some deviations from the OECD guideline 404. For example the test item was tested under occlusive instead of semi-occlusive conditions. Further, an exposure period of 20 hours instead of 4 hours was applied. The named deviations from the OECD guideline 404 represents a tightening of the test conditions. Based on the results of this test, the test substance is considered not irritating to the skin.