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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:
From 31 AUG 1999 to 09 SEP 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
17 JUL 1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
31 JUL 1992
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Batch: V.N0199.064
Expiry: 09.07.2001

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombres, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: male: 13 weeks, females 14-15 weeks
- Weight on day of treatment: male 2467 g, females 2937 and 2583 g
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintainance diet, ad libitum, haysticks provided by Eberle Nafag AG, CH-9200 Gossau
- Water: Community tap water, ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied : 0.5 g/animal, moistened with bi-distilled water
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
1 male, 2 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: substance applied on surgical gauze patch, covered with semi-occlusive dressing, wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm tap water
- Time after start of exposure: 4 h, at the end of exposure time

OBSERVATION TIME POINTS
1, 24, 48 and 72 h after removal of the test substance

SCORING SYSTEM:
- Method of calculation: The skin reactionwas assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEc, July 31, 1992.
The primary irritation score was calculated by totalling the individual cummulative scores at 24, 48 and 72 h and then dividing by the number of data points.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No corrosive or irriating effects observed.

Any other information on results incl. tables

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality ocurred.

Yellow stainig of the treated skin was observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not reveal any irritation potential on the skin of rabbits, tested in this study according to OECD test guideline no. 404 and GLP conditions.
Executive summary:

The skin irritating potential of the test item was assessed according to OECD TG 404. Three rabbits (1 male and 2 females) were exposed to 0.5 mg test item under semi-occlusive conditions for 4 hours. Yellow staining produced by the colour of the test item on the treated skin was observed in all animals at the 1-hour reading and persisted up to the 48- or 72-hour reading. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.