Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

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: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 14 weeks (male), 15 - 16 weks (female)
- Weight at study initiation: 2.8 - 3.2 kg
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15/hour
- Photoperiod (hrs dark / hrs light): 12/12 hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g (per animal) of test article was weighed as delivered and then moistened with approximately 0.1 ml bi-distilled water before application.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 (1 male, 2 female)
Details on study design:
TEST SITE:
Four days before treatment the left flank was clipped with an electric clipper, exposing an area of approximately (10 x 10 cm). The skin of the
animals was examined approximately 24 hours before treatment, and regrown fur of all animals was again clipped.
No animals with overt sign of injury or marked irritation which may have interfered with the interpretation of the results were used in the test.
The prepared test article was placed on a gauze patch and applied to an area of approximately 6 cm2 of the intact skin of the clipped area.
The patch was covered with a semi-cocclusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
The duration of the treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 to72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: no effect
Irritant / corrosive response data:
Irritation:
Application of the test article to healthy intact rabbit skin did not elicit any skin reactions at the application site at any of the observation times (all scores 0).

Corrosion:
No irreversible alterations of the treated skin wre obsereved nor were corrosive effects evident on the skin.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortility occurred.

No staining by the test article of the treated skin was observed.

The body weight of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the criteria stated in EEC Commission Directive 93/21/EEC, classification of CA 2218 A (Intermediate of CGA 276854) is not required.
Executive summary:

The primary skin irritation potential of CA 2218 A (Intermediate of CGA 276854) was investigated by Topical application of 0.5 g to 6 cm2intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the 24, 48 and 72 hour reading times were calculating the respective mean values for each type of lesion. 

The test article did not elicit any skin reactions at the application site at any of the observation times (all scores 0). The mean values from 24 to 72 hours were therefore 0 for erythema and 0 for oedema. 

The test article caused no staining of the treated skin. 

No corrosive effects were noted on the treated skin of any animal at any measuring interval. 

Based upon the criteria stated in EEC Commission Directive 93/21/EEC, classification of CA 2218 A (Intermediate of CGA 276854) is not required.