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:
1999
Report Date:
1999

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 (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, 01400 Chatillon sur Chalaronne, France
- Age at study initiation: 2 - 3 months
- Weight at study initiation: 2020 - 2430 g
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): 13 - 14 hour
- Photoperiod (hrs dark / hrs light): 12/12 hours

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
Volume applied: 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:

Pre-treatment:
Approximately 24 hours before treatment, an area of approximately 10 cm wide from one flank to the other (across the back) of each animal shaved with an electric clipper.

Treatment:
The test article was applied to the shaved skin on one flank by means of a gauze patch (2 cm x 3 cm). A control patch was applied to the other flank. The patches were loosely covered with aluminium foil and held in place with adhesive tape. Control patches were moistened with distilled water to improve contact.

Post treatment:
4 hours after treatment, the dressings were removed and the area washed with lukewarm water to remove any remaining test article.

Scoring method:
EPA/OECD (Draize Scale)

Skin examinations:
1, 24, 48 and 72 hours after patch removal.

Clinical Observations:
Checked daily

Mortality:
Checked daily

Body weight:
Measured and recorded immediately before dose administration and at 72 hour examination (study end).


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:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:

Skin Examination:
Very slight erythema (score 1) was observed in two animals (no. 088 and 043) at the 1-hour examination. All skin reactions were fully reversed within 24 hours.
For results see Table 1.
Calculated skin irritation indices and scores according to OECD/EEC guidelines are presented in Table 2.

Other effects:

Mortality:
There was no mortality in the test.

Clinical Observations:
There were no remarkable clinical observations.

Body weights:
Body weights were not affected by treatment. Individual body weights presented din Table 3.

Classification:
According to Commission Directive 93/21/EEC, issued May 4, 1993, the results of this test indicate that CA 2219 A (Intermediate of CGA 276854) is not required to be classified for skin irritation.

Any other information on results incl. tables

Table1: Individual Dermal Irritation Scores (Draize)

ANIMAL NO.

MALES

088

043

166

 

ERYTHMA AND ESCHAR

 

CF

TF

CF

TF

CF

TF

AFTER 1 HOUR

AFTER 24 HOURS

AFTER 48 HOURS

AFTER 72 HOURS

0

0

0

0

1

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

 

EDEMA

AFTER 1 HOUR

AFTER 24 HOURS

AFTER 48 HOURS

AFTER 72 HOURS

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

CF: CONTROL FLANK    TF: TEST FLANK

 

Table 2: Summary Dermal Irritation Scores (OCED/EEC)

ANIMAL NO.

MALES

 

088

043

166

 

ERTHYEMA AND ESCHAR

MEAN SCORE 24 – 72 HOURS

0

0

0

OVERALL MEAN SCORE 24 – 72 HOURS

0

 

 

EDEMA

MEAN SCORE 24 – 72 HOURS

0

0

0

OVERALL MEAN SCORE 24 – 72 HOURS

0

 

Table 3: Body Weights (g)

ANIMAL NO.

MALES

 

088

043

166

AT TEST START

AFTER 3 DAYS

2020

2080

2190

2270

2430

2440

 

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the test results, CA 2219 A (Intermediate of CGA 276854) is not required to be classified according to Commission Directive 93/21/EEC, issued May 4, 1993.
Executive summary:

A dermal irritation/corrosion was conducted with test article CA 2219 A (Intermediate of CGA 276854) (batch 249-GE001/SU). The test article (0.5 ml) was applied to the shaved skin of three rabbits for four hours under occlusive conditions. The test sites were examined for skin irritation at 1, 24, 48 and 72 hours after patch removal.

The test article caused skin irritation in two animals. Very slight erythema was observed after the 1 hour examination. All skin reactions were fully reversed within 24 hours after patch removal. There was no mortality, and there were no remarkable clinical observations. Body weights were not affected by treatment. 

Calculation of mean scores for individual animals (EEC method, 24 – 72 hours) for erythema and eschar, and edema resulted in scores of 0, with an overall mean of 0. 

According to the test results, CA 2219 A (Intermediate of CGA 276854) is not required to be classified according to Commission Directive 93/21/EEC, issued May 4, 1993.