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 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, F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: Male 17 weeks. Females 14 weeks.
- Weight at study initiation: 2.6 - 3.1 kg
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5ml (per animal)
- Concentration: undiluted as supplied
- pH: 6.0
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 (1 male, 2 females)
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 cm x 10 cm. The skin of the animals was examined approximately 24 hours before treatment, and regrown fur of all animals was clipped again.

On the day of treatment, 0.5 ml of test item were put on a surgical gauze patch (ca. 2.5 cm x 2.5 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
The duration of 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.


OBSERVATIONS:
Viability/Mortality: Daily from delivery of animals to the termination of the test.
Clinical Signs: Daily from delivery of animals to the termination of the test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.


SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC at approximately 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after the removal of the dressing, gauze patch and test item.


TERMINAL SACRIFICE:
All animals were sacrificed at end of observation period.
No necropsy was performed.

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
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Application of the test item to healthy intact skin did elicit a dry and inelastic skin at the 1 hour examination through 10 days after treatment in all animals. A very slight erythema was noted in only one animal at the 24 hour examination and persisted through 7 days.
Other effects:
Viability/Mortality: No clinical signs of systemic toxicity were observed in the animals during the test and observation period.
No mortality occurred.

Coloration: A light brown staining produced by the test article was observed on the test site during the whole observation period
and did not influence the skin reading.

Corrosion: No irreversible alterations of the treated skin were observed nor were corrosive effects noted on the treated skin of
any animal.

Body weights: The body weight of the animals was considered to be within the normal range of variability.

Any other information on results incl. tables

Individual Skin Irritation Scores

Animal Number

Sex

Evaluation Interval

Corneal Opacity

Iris

64

65

66

M

F

F

1 hour

0

0

0

0

0

0

 

64

65

66

M

F

F

24 hours

1

0

0

0

0

0

 

64

65

66

M

F

F

48 hours

1

0

0

0

0

0

 

64

65

66

M

F

F

72 hours

1

0

0

0

0

0

 

64

65

66

M

F

F

7 days

1

0

0

0

0

0

 

64

65

66

M

F

F

10 days

0

0

0

0

0

0

 

64

65

66

M

F

F

14 days

0

0

0

0

0

0

 

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 2814 B (Intermediate of CGA 276854) is not required.
Executive summary:

The primary skin irritation potential of CA 2814 B (Intermediate of 276854) was investigated by topical application of 0.5 ml to 6 cm2intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment of treatment was for 4 hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours as well as 7, 10 and 14 days after removal of the dressing. The scores of each animal at the 24, 48 and 72 hour reading times were used in calculating the respective mean values for each type of lesion. 

 

Application of the test item to healthy intact skin did elicit a dry and inelastic skin at the 1 hour examination through 10 days after treatment in all animals. A very slight erythema was noted in only one animal at the 24 hour examination and persisted through 7 days. 

 

The mean values from 24 to 72 hours (criteria for evaluation according the EEC Commission Directive 93/21/EEC) were 0.33 for erythema and 0 for oedema. 

 

All skin reactions were clear within 14 days after treatment. 

 

A light brown staining produced by the test article was observed on the test site during the whole observation period and did not influence the skin reading. 

 

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 2814 B (Intermediate of CGA 276854) is not required.