Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Internationally accepted guideline, well documented and scientifically acceptable.

Data source

Reference Type:
study report
Report Date:

Materials and methods

Test guideline
according to
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
GLP compliance:
Pre GLP.

Test material


Test animals

Details on test animals and environmental conditions:
- Test animals: rabbits Russian.
- Weight at study initiation: 1.5 to 2 kg.
- Housing: individually housed in metal cages.
- Diet: ad libitum, standard rabbit food NAFAG, Gossau SG.
- Water: ad libitum.
- Acclimation period: for a minimum of 8 days.

- Temperature: 18 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 14 hrs light cycle day.

Test system

Type of coverage:
Preparation of test site:
other: shaved and abraded skin.
unchanged (no vehicle)
yes, concurrent no treatment
Amount / concentration applied:
- Amount applied: 0.5 g.
- Application: gauze patches of 2.5 x 2.5 cm with test substance were applied to the prepared abraded and non abraded skin.
Duration of treatment / exposure:
The dressing were removed after a 24 hrs exposure.
Observation period:
72 hours.
Number of animals:
3 males and 3 females.
Details on study design:
- Area of exposure: two days 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.
- Type of wrap if used: patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

The skin irritation was scored immediately and 48 hours after removal of the dressings (24 and 72 hours after initiation of treatment).
The severity of skin irritation was rated as follow: a mean value of less than 2 indicated mild, from 2 to 5 moderate and above 6 severe skin irritation.

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

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

Results and discussion

In vivo

Irritant / corrosive response data:
Primary irritation index was estimated to be 1.2; the substance caused therefore a mild skin irritation to rabbit.

Any other information on results incl. tables

Skin Irritation - Intact skin

Animal/sex Reaction 24 hrs 72 hrs
1 M Erythema 0 0
2 M Erythema 1 0
3 M Erythema 0 0
4 F Erythema 1 0
5 F Erythema 1 0
6 F Erythema 1 0
1 M Oedema 0 0
2 M Oedema 0 0
3 M Oedema 0 0
4 F Oedema 0 0
5 F Oedema 1 0
6 F Oedema 1 0

Skin reactions - abraded skin

Animal/sex Reaction 24 hrs 72 hrs
1 M Erythema 2 0
2 M Erythema 2 1
3 M Erythema 1 1
4 F Erythema 2 1
5 F Erythema 2 0
6 F Erythema 2 1
1 M Oedema 0 0
2 M Oedema 2 1
3 M Oedema 1 0
4 F Oedema 1 0
5 F Oedema 1 0
6 F Oedema 2 0

Applicant's summary and conclusion

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


The skin irritation potential was assessed following the procedure of the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).



Primary irritation index was estimated to be 1.2; mild irritating.

Discussion and conclusion

The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results, because the raw tables are included into the study report.

Despite the reaction scores at 48 hours were not reported, the mean value scored is reasonably expected to be less than 2.3 for erythema/eschar and for oedema in at least 2 of 3 tested animals, in both intact and abraded skin, from gradings at 24, 48 and 72 hours after patch removal.

In conclusion, it is reasonable to NOT classify the substance as skin irritant according to the CLP Regulation (EC 1272/2008).