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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:
The study was conducted in 1979.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A single application of the test material was added to a 2 cm2 of clipped skin on the flank of a guinea pig. Skin reactions were noted at 24 h.
GLP compliance:
no
Remarks:
Study pre-dates GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material: Limetol

Test animals

Species:
guinea pig
Strain:
not specified
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
open
Preparation of test site:
clipped
Vehicle:
other: Ethanol
Controls:
no
Amount / concentration applied:
0.025 mL at concentrations of 1, 3, 10, 30 and 100 % for a single application and for continous application for 21 days as part of the skin sensitisation test.
Duration of treatment / exposure:
24 hours single aplication.
21 days for contineous application.
Observation period:
24 hours single aplication.
21 days for contineous application.
Number of animals:
No data
Details on study design:
A single application of 0.025 mL of each test concentration was simultaneously performed on one of the area measuring 2 cm2 of the flank of skin previously clipped and marked with a circular stamp.
The skin reactions were read 24 hours after the application of the test material. The minimum and maximum non-irritant concentrations were determined by an all-or-none criterion. The minimal irritant concentration was defined as the lowest one causing skin irritation. The maximal non-irritant concentration was defined as the highest one nont causing macroscopic skin irritations in any of the animals.
For the sensitisation determined by the OET on guinea pigs, the test substance was applied contineously for 21 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Lowest irritant concentration
Basis:
other: No data
Time point:
other: 24 h
Score:
30
Reversibility:
no data
Irritation parameter:
other: Highest non-irritant concentration
Basis:
other: No data
Time point:
other: 24 h
Score:
10
Reversibility:
no data
Other effects:
After repeated applications over 21 successive days, slight skin irritation was observed at 7 days with a test concentration of 100 %. By 14 days this had increased to strong irritation. By 21 days slight irritation was observed although the first application site was changed because of strong skin irritation after 2 weeks of treatment.
At 30 % concentration, very slight irritation was observed at 7 and 14 days with moderate irritation observed at 21 days.
At 10 % concentration, no irritation was observed at 7 days; very slight irritation was observed at 14 and 21 days,
At 3 % concentration, no irritation was observed at 7, 14 or 21 days.

Any other information on results incl. tables

Skin irriation after a single application

Solvent

Lowest irritant concentration

Highest non-irritant concentration

Ethanol

30 %

10 %

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
After a single application of the test substance, 10 % in ethanol does not irritate the skin.
Repeated application of the test substance at 100 % indicated irritation after 21 days. However, after 7 days of repeated treatment only very slight irritiation was observed at 100%.
Executive summary:

The skin irritation potential of the test substance was assessed in guinea pigs. After a single application of the test substance, 10 % in ethanol does not irritate the skin. 30 % was the lowest concentration which gave very slight irritation after a single application of the test substance. In addition, after 14 days continuous application at 30%, only very slight irritation was observed. The test substance at 100% (neat) after 7 days continuous application gave rise to only very slight irritation. Therefore under the current CLP guidance, no classification is required.