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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:
other: Well-documented pre-guideline study without GLP. Observations can be re-assessed according to present day criteria based on available data

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
A different method has been used to evaluate the study. The Draize score reading is available and therefore data can be translated in the OECD 404-type of evaluation.
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Version / remarks:
FR 43, No., 163, Aug. 22, 1978
Principles of method if other than guideline:
The primary irritation index is calculated by summing up erythema and edema scores for the intact and abraded skin and divided by 4.
The exposure period is 24 hours instead of 4 hours
The exposure is both on abraded and non-abraded skin
Observation period is 7 days instead of 14 days after treatment
GLP compliance:
no

Test material

Constituent 1
Test material form:
liquid
Details on test material:
Batch: 502834

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ivanovas, 7964 Kissleg/Allgau, germany and Madorin AG, 4114 Fullinsdorf, Switzerland)
- Age at study initiation: adult
- Weight at study initiation: 2-3 kg
- Housing: individual housing in metal cages
- Diet (e.g. ad libitum): Rabbit standard food, NAFAG No. 814 (Nafag, Gossau, Switzerland)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): n/a
- Photoperiod (hrs dark / hrs light): 14/10.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and non-abraded (shaved)
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Patches of 2.5 cm * 2.5 cm loaded with 0.5 ml of the undiluted test material.
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
Before the treatment the entire back and the flank of the rabbits were shaved with an electric clipper. Immediately before treatement the shaven skin on one side was scarified (abraded). Gauze patches of 2.5 cm x 2.5 cm loaded with 0.5 ml of the test substance were applied to the abraded and intact skin.
The patches were covered with an impermeable material and were fastened to the body with the rabbit with adhesive tape. The dressings were removed after 24 hour application.
The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of the following evaluation scheme:
Score 0: No erythema
Score 1: Very slight, barely perceptible erythema
Score 2: Well defined erythema
Score 3: Moderate to severe erythema
Score 4: Severe erythema (beet redness) to slight eschar formation

Score 0: No edema
Score 1: Very slight, barely perceptible edema
Score 2: Slight edema, edges of area well defined by definitive raising
Score 3: Moderate edema (raised approximately 1 mm)
Score 4: Severe edema (raised > 1 mm and extending beyond are of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: mean of six animals
Time point:
other: 24 hours
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: mean of six animals
Time point:
other: 48 hours
Score:
0.8
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: mean of six animals
Time point:
other: 72 hours
Score:
0.6
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: mean of six animals
Time point:
other: 4 days
Score:
0.5
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
other: mean of six animals
Time point:
other: 7 days
Score:
0.16
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: mean of six animals
Time point:
other: 24 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: mean of six animals
Time point:
other: 48 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: mean of six animals
Time point:
other: 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: mean of six animals
Time point:
other: 4 days
Score:
0.16
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
other: mean of six animals
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
24 hours No. 243 No. 244 No. 245 No. 246 No. 247 No. 248
Erythema intact skin 1 0 2 1 1 2
abraded skin 2 1 2 2 2 2
Edema intact skin 0 0 1 0 0 1
abraded skin 0 0 2 0 1 2

48 hours
Erythema intact skin 0 0 2 1 1 1
abraded skin 0 0 2 2 2 2
Edema intact skin 0 0 1 0 0 1
abraded skin 0 0 2 1 1 2

72 hours
Erythema intact skin 0 0 1 1 1 1
abraded skin 0 0 2 2 2 2
Edema intact skin 0 0 1 0 0 1
abraded skin 0 0 2 1 1 2

4 days
Erythema intact skin 0 0 0 1 1 1
abraded skin 0 0 2 2 2 2
Edema intact skin 0 0 0 0 0 1
abraded skin 0 0 2 1 1 2

7 days
Erythema intact skin 0 0 0 1 0 0
abraded skin 0 0 2 2 2 2
Edema intact skin 0 0 0 0 0 0
abraded skin 0 0 2 1 1 2

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: The assessment was performed according to the EEC Guidelines with the scoring from the study.
Conclusions:
Based upon the classification criteria (Commission Directive 2001/59/EC of August 2001), the substance is considered to be “not irritating” to rabbit skin.
Executive summary:

The primary skin irritation potential of the test material was investigated according to guidelines proposed by the US EPA, FR Vol. 43, No. 163, August 22, 1978. The test item was applied by topical occlusive application of 0.5 mL to the intact and abraded skin of each of six young adult New Zealand White rabbits (3 males and 3 females). The duration of treatment was 24 hours. The scoring of skin reactions was performed 24, 48 and 72 hours, as well as 4 and 7 days after removal of the dressing.

The application of the test material to the intact and abraded skin resulted in mild to mederate erythema and edema in all six animals. These effects were reversible on the intact skin and were no longer evident 7 days after treatment, the end of the observation period for all animals, except in one female animal where mild erythema was still present.

Thus, the test item did not induce significant damage to the skin and it can be anticipated that full reversibilty would occur within 14 days on the intact skin.

Therefore, the substance was considered to be slightly irritant under the test condition but does not have to be classified with respect to skin irritation.