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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: Testing procedures do not follow an official European testing guideline, nevertheless the studies are well documented and the results scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
no

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: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf.
- Weight at study initiation: 2-3 kg.
- Housing: individually in metal cages.
- Diet: rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water: water ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ±3 °C
- Humidity: 55 ± 15 %
- Air changes: 15 air change/h.
- Photoperiod: 12/12 hrs dark / hrs light.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin.
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Application: gauze patches soaked with 0.5 ml of the test material were applied to the abraded and intact skin.
Duration of treatment / exposure:
The dressings were removed after 24 hours.
Observation period:
7 days
Number of animals:
6 (3 males and 3 females).
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. Immediately before treatment, the skin on one side was slightly scarified.
- Type of wrap if used: the gauze patches with substance were covered with an impervious material and were fastened to the body of the rabbit with adhesive tape.

SCORING SYSTEM
Skin reactions were assessed on removal and after 48 and 72 hours and 4 and 7 days.
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
other: 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: 24, 48 and 72 hours
Score:
< 2.3
Reversibility:
fully reversible
Remarks on result:
other: both intact and abraded skin
Irritant / corrosive response data:
The calculated primary irritation index was 2.33.

Any other information on results incl. tables

INTACT skin reactions

Animal/sex Reaction 24 hrs 48 hrs 72 hrs 4 days 7 days Mean 24, 48 and 72 hrs
55 M Erythema 2 2 2 1 0 2.00
56 M Erythema 2 2 2 2 0 2.00
57 M Erythema 2 2 2 1 0 2.00
58 F Erythema 2 2 2 1 0 2.00
59 F Erythema 2 1 1 0 0 1.33
60 F Erythema 2 1 1 0 0 1.33
55 M Oedema 1 1 1 0 0 1.00
56 M Oedema 1 2 1 1 0 1.33
57 M Oedema 1 1 1 0 0 1.00
58 F Oedema 1 0 0 0 0 0.33
59 F Oedema 1 0 0 0 0 0.33
60 F Oedema 1 0 0 0 0 0.33

ABRADED skin reactions

Animal/sex Reaction 24 hrs 48 hrs 72 hrs 4 days 7 days Mean 24, 48 and 72 hrs
55 M Erythema 2 2 1 1 0 1.50
56 M Erythema 2 1 1 0 0 1.00
57 M Erythema 0 0 0 0 0 0.00
58 F Erythema 2 2 2 0 0 1.50
59 F Erythema 2 1 1 0 0 1.00
60 F Erythema 2 1 1 0 0 1.00
55 M Oedema 2 1 1 1 0 1.33
56 M Oedema 1 1 0 0 0 0.67
57 M Oedema 0 0 0 0 0 0.00
58 F Oedema 2 1 0 0 0 1.00
59 F Oedema 1 0 0 0 0 0.33
60 F Oedema 1 0 0 0 0 0.33

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:
Not irritating.
Executive summary:

Method

The skin irritation potential was assessed with test procedure similar to those outlined in the EPA OPP 81-5 (Acute Dermal Irritation) guideline.

Results

Primary irritation index was estimated to be 2.33, therefore the substance resulted moderate 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 according to the CLP Regulation (EC 1272/2008), because the raw tables are included into the study report. Only the intact skin reactions were considered.

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.

In conclusion, the test item can be classified as NON irritating, according to the CLP (EC 1272/2008) Regulation.