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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
Study period:
04.02. - 12.03.1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Appearance: yellow liquid
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Füllinsdorf, Switzerland
- Weight at study initiation: 2030 - 2560 g
- Housing: individually in metal cages
- Age at study initiation: approx. 12 - 14 weeks old
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Photoperiod: 12 hours dark/12 hours light

IN-LIFE DATES: from 04 to 11 February 1986

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL of the test item were applied (unchanged).
Duration of treatment / exposure:
4 hours
Observation period:
7 days; the skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches. The observation period was extended to 7 days to determine the reversibility of the skin reactions.
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm² on the flanks
- Type of wrap if used: The gauze patch was loosely covered with an aluminium foil (approx. 36 cm² ) and held in place for 4 hrs by an adhesive tape.

SCORING SYSTEM:
The skin reactions were evaluated 1, 24, 48, 72 hours and on day 7 after removing the gauze patches according to the OECD scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Minimal erythema was observed in all animals, reversible within 7 days the latest. One animal displayed a minimal edema reactions 1 hour after removal of the dressing, this effect was reversible within 24 hours. All other scores for edema were zero.
Other effects:
A severe loss of weight was observed in one animal caused by rejection of food. The other two gained weight normally.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, the test article only caused minimal reactions of the skin below the regulatory significance and is therefore regarded as not irritating to the rabbit skin.
Executive summary:

The primary skin irritation potential of the test substance was investigated in a GLP compliant study according to OECD test guideline no. 404. The test item was applied by topical occlusive application of 0.5 ml to the intact flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches. The observation period was extended to 7 days to determine the reversibility of the skin reactions. The animals were checked daily for systemic symptoms and mortality. A severe loss of weight was observed in one animal caused by rejection of food. The other two gained weight normally. The individual mean scores for erythema for each of the three animals were 0.66, 1.0 and 0.33, respectively. One animal displayed an edema reaction 1 hour after removal of the dressing (score = 1), this effect was reversible within 24 hours. All other scores for edema were zero. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals. Thus, the test item did not induce significant irreversible damage to the skin and is therefore not regarded as a skin irritant.