Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study test phase 2005-09-27 to 2005-10-20. Report completed & signed off 2005-12-21.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

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: supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0 - 3.5kg
- Housing: Individually in suspended cages
- Diet: Free access to food (Certified rabbit diet) was allowed throughout the study
- Water : Free access to mains drinking water was allowed throughout the study
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 deg. C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h light / 12h dark:

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Distilled water
Controls:
no
Amount / concentration applied:
500 mg of the test substance moistened with 0.5ml of distilled water
Duration of treatment / exposure:
4 h
Observation period:
One hour after the removal of patches and 24, 48 and 72 hours later the test sites were examined for evidence of primary irritation.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: back of each rabbit
- Type of wrap if used: Patch secured with surgical adhesive tape. The trunk of the rabbit was wrapped in an elasticated corset to prevent the animal interfering with the patches.

REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test material was removed by gently swabbing with cotton wool soaked in 74% Industrial Methylated Spirit.
- Time after start of exposure: First rabbit had 3 patches applied one of which was removed at each of 3 time points - 3m, 1h and 4h. The two remaining animals (with only 1 patch applied each) had patches removed after 4h.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Erythema/Eschar Formation
Basis:
animal: 64
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
6
Reversibility:
fully reversible within: 24h
Irritation parameter:
other: Erythema/Eschar Formation
Basis:
animal: 28 Male
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
6
Reversibility:
fully reversible within: 72h
Irritation parameter:
other: Erythema/Eschar Formation
Basis:
animal: 33 Male
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
6
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal: 64 Male
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
6
Reversibility:
other: No oedema formation
Irritation parameter:
edema score
Basis:
animal: 28 Male
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
6
Reversibility:
other: No oedema formation
Irritation parameter:
edema score
Basis:
animal: 33 Male
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
6
Reversibility:
fully reversible within: 72h
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days. One treated skin site appeared normal at the 24h observation, one other treated skin site appeared normal at the 72h observation and the remaining treated skin site appeared normal at the 7 day observation.
Other effects:
In the rabbit treated with 3 patches no evidence of skin irritation was noted after 3min. and 1h expsoure periods.

Any other information on results incl. tables

Interpretation of Results

Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme

The scores for erythema and oedema at the 24 and 72 - Hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test item. The test item was classified according to the following scheme devised by Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Austin, Texas, p.47:

Primary Irritation Index

Classification of Irritancy

     0

Non-irritant

> 0 to 2

Mild irritant

> 2 to 5

Moderate irritant

> 5 to 8

Severe irritant

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information mild irritant Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 0.7 and was classified as amild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were recorded.
Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following guidelines:

OECD Guidelines for the Testing of Chemicals No. 404 'Acute Dermal Irritation/Corrosion' (adopted 24 April 2002)

Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC

Results

A single 4h semi-occluded application of the test material to the intact skin of 3 rabbits produced very slightly erythema and very slight oedema. One treated skin site appeared normal at the 24h observation, one other treated skin site appeared normal at the 72h observation and the remaining treated skin site appeared normal at the 7 day observation.

3 min. and 1h semi-occluded applications of the test substance to intact skin of one rabbit produced no evidence of skin irritation.

Conclusion

The test material produced a primary irritation index of 0.7 and was classified as a mild irritant to rabbit skin according to Draize classification scheme.