Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 August 1989 to 5 September 1989.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
NO GLP methodology followed and this test was based on the OECD Guideline No. 404, adopted May 12, 1981, by the OECD council, and on Annex V, part B of Council Directive 7 9/831/EEC (Commission Directive 84/449/EEC of April 25, 1984; Official Journal L251, September 19, 1984).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid, moltem mass
Details on test material:
- Test article: FAT 92267/A
- Batch N°: EN 3.86
- Content of active ingredients: 81.1%
- Physical properties: Solid, molten mass
- Storage conditions: Room temperature
- Safety precautions: Gloves and face masks
- Test material received: August 18, 1989.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Approx. 12-14 weeks old
- Weight at study initiation: 2240 gr to 2990 gr
- Housing: The animals were housed individually in metal cages, identified by ear tattoo
- Diet (e.g. ad libitum): The rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: A control gauze patch moistened with distilled water was applied to the contralateral flanl.
Amount / concentration applied:
0.5 ml of the test article was applied to the right flank of each animal.
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were evaluated 1, 24, 48 and 72 hours afetr removing the gauze patches.
Number of animals:
3 female rabbits
Details on study design:
An area of at least 36 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm2 ) bearing 0.5 ml of the test article was applied to the right flank of each animal. A control gauze patch moistened with distilled water was applied to the contralateral flank.
The patches were loosely covered with an aluminum foil (approx. 36 cm2 ) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

SCORING SYSTEM:
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 ( inj uries in depth): 4
Total 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 nun): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
662 female
Time point:
other: mean score at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Non-irritant
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
876 female
Time point:
other: mean score at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Non-irritant
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
984 female
Time point:
other: mean score at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Non-irritant
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
662 female
Time point:
other: mean score at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Non-irritant
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
876 female
Time point:
other: mean score at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Non-irritant
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
984 female
Time point:
other: mean score at 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Non-irritant
Other effects:
All animals showed expected gain in body weight during the study.

Any other information on results incl. tables

Body weight (g):

 Animal N°  662/Female  876/Female  984/Female
 At strat of test  2990 gr.  2240 gr.  2450 gr.
 After 3 days  3030 gr.  2300 gr.  2530 gr.
 After 7 days (end)  3110 gr.  2370 gr  2650 gr.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the experimental conditions employed, FAT 92267/A is non-irritant to the skin rabbit.
Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit according to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

 

 Results

A single 4‑Hour, occlusive application of the test item to the intact skin of three females rabbits produced no erythema and no edema after patch removal and during the observation peiod. 

Conclusion

The test item produced a primary irritation index of 0.0 and was classified as non‑irritant to rabbit skin. No corrosive effects were noted.