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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Internationally accepted guideline, well documented and scientifically acceptable.

Data source

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

Materials and methods

Principles of method if other than guideline:
The procedure used is described in the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
GLP compliance:
no
Remarks:
Pre GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgäu, Germany and MADOERIN AG, 4414 Füllinsdorf, Switzerland.
- Age at study initiation: adult, age not specified.
- Weight at study initiation: 2 to 3 kg.
- Housing: housed individually in metal cages.
- Diet: ad libitum, standard rabbit food - NAFAG, No. 814, Gossau SG.
- Water: ad libitum.
- Acclimation period: prior to treatment they were adapted to our laboratories for a minimum of 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Relative humidity: 55 ± 10 %
- Photoperiod: 10 hours light cycle day.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded.
Amount / concentration applied:
TEST MATERIAL
- Application: gauze patches of 2.5 x 2.5 cm laden with test substance.
- Amount of test substance: 0.5 ml.
Duration of treatment / exposure:
The dressing were removed after a 24 hours exposure.
Observation period:
7 days
Number of animals:
3 male and 3 female.
Details on study design:
TEST SITE
- Area of exposure: before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland.
- Type of wrap if used: the patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

SCORING SYSTEM
The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of the following evaluation scheme.

Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Maximum possible erythema score: 4

Edema Formation
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by definite raising): 2
Moderate edema (raised approximately 1 mm): 3
Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible erythema score: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
other: mean 24, 48 and 72 hours
Score:
< 2.3
Reversibility:
fully reversible
Remarks on result:
other: both intact and abraded skin
Irritation parameter:
edema score
Basis:
animal: 6/6
Time point:
other: mean 24, 48 and 72 hours
Score:
< 2.3
Reversibility:
fully reversible
Remarks on result:
other: both intact and abraded skin
Irritant / corrosive response data:
Test substance was found to cause a minimal irritation when applied to intact and abraded rabbit skin.

Any other information on results incl. tables

Evaluation of the skin reactions

Intact skin

Animal/sex Reaction 24 hrs 48 hrs 72 hrs 4 days 7 days Mean 24, 48 and 72 hrs
274 M Erythema 0 0 0 0 0 0
275 M Erythema 0 0 0 0 0 0
276 M Erythema 0 0 0 0 0 0
277 F Erythema 0 0 0 0 0 0
278 F Erythema 0 0 0 0 0 0
279 F Erythema 0 0 0 0 0 0
274 M Oedema 0 0 0 0 0 0
275 M Oedema 0 0 0 0 0 0
276 M Oedema 0 0 0 0 0 0
277 F Oedema 0 0 0 0 0 0
278 F Oedema 0 0 0 0 0 0
279 F Oedema 0 0 0 0 0 0

Abraded skin

Animal/sex Reaction 24 hrs 48 hrs 72 hrs 4 days 7 days Mean 24, 48 and 72 hrs
274 M Erythema 0 0 0 0 0 0.00
275 M Erythema 1 1 0 0 0 0.67
276 M Erythema 1 0 0 0 0 0.33
277 F Erythema 1 1 0 0 0 0.67
278 F Erythema 1 1 0 0 0 0.67
279 F Erythema 2 2 1 0 0 1.67
274 M Oedema 0 0 0 0 0 0.00
275 M Oedema 0 0 0 0 0 0.00
276 M Oedema 0 0 0 0 0 0.00
277 F Oedema 0 0 0 0 0 0.00
278 F Oedema 0 0 0 0 0 0.00
279 F Oedema 0 0 0 0 0 0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
Non irritating.
Executive summary:

Method

The test was conducted following the procedures described in the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81 -5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.

Results

Test substance was found to cause a minimal irritation when applied to intact and abraded rabbit skin.

Conclusion

According to the CLP Regulation (EC 1272/2008), test substance can be classified as non irritating. The mean value scored is less than 2.3 for erythema/eschar and for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal, in both the cases of intact and abraded skin.