Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Draize, J.H. (1959). Dermal toxicity. Appraisal of the safety of chemicals in foods, drugs and cosmetics. The Assoc. of Food and Drug Officials of the United States. Texas State Dept. of Health, Austin, TX, p. 46
Version / remarks:
1959
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: New dermatological physiology and safety (evaluation of the toxicity of contact chemical substances), edited by Yoshio Takase, Hideyo Ogawa, and Kikuhiko Okamoto (Seishi Shoin)
Version / remarks:
1973 Federal Register method
Deviations:
not specified
Principles of method if other than guideline:
- Principle of test: Intact and abraded sites of skin are exposed to the test material, under occlusive bandaging for a period of 24 hours, after which each site is graded for both erythema and edema at 24, 48, and 72 hours, and 4 and 5 days after application.

- Short description of test conditions: Two shaved intact and two shaved abraded skin sites per animal, in 6 animals, are exposed to the test material under occlusive bandaging for contact with these areas of skin for 24 hours, after which erythema and edema are graded per skin location at 24, 48, and 72 hours, and 4 and 5 days after application. The 4 application sites per animal consist of 1) 100% test material on intact skin, 2) 100% test material on abraded skin, 3) 50% (w/w) test material in petrolatum on intact skin, 4) 50% (w/w) test material in petrolatum on abraded skin.

- Parameters analysed / observed: The intact and abraded skin sites for each treatment in each of the 6 animals used on test were graded by naked eye using Draize scoring for erythema and crust formation, and for edema formation. An irritation index was determined using the sum of the total erythema points plus the total edema points, and then dividing by the number of animals (6).
1) The Primary Irritation Index (P.I.I.) was calculated by adding all 8 scores obtained for each animal, dividing the sums obtained by 4, and calculating the average for 6 animals. A P.I.I. of 0 to 2 according to the Draize score methodology equates to an irritation rating of "Slightly irritant."
2) The degree of irritation in the intact skin was evaluated by adding all 4 scores obtained from each animal, dividing the sums obtained by 4, and calculating the average for 6 animals. According to the method of Campbell et al, the test material resulted in an evaluation of "not irritant and safe for application to intact skin."
GLP compliance:
no

Test material

Test animals

Species:
rabbit
Strain:
other: Japanese White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 to 3 kg
- Housing: stainless steel caging
- Diet: Pellet feed (RC4; Oriental Yeast Co., Ltd.), ad libitum
- Water: municipal tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 ± 2.5
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 16 / 8

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
50% (w/w) using petrolatum was also tested
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 h
Observation period:
5 days
Reading time points: 24, 48 and 72 h, and 4 and 5 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Four 1 inch diameter areas of flank skin on each animal
- Type of wrap if used: fabric bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24, 48, and 72 h, and 4 and 5 days

SCORING SYSTEM
Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
100%
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
100%
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
50% (w/w) using petrolatum was also tested and no irritation was observed (score 0 at all observation time points)

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
In this primary skin irritation study in rabbits, the test material showed no irritant effect on either intact or abraded skin at 100% or 50% (w/w; in petrolatum), indicating that it is a non-irritant.

Categories Display