Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 15, 1992 - June 22, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC Directives 83/467 and 84/449
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Conelli - Arona
- Weight at study initiation: 2.5-3.5 kg
- Housing: stainless steel cages
- Diet (e.g. ad libitum): pellet complete diet
- Water (e.g. ad libitum): filtered tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 degree C
- Humidity (%): 55 +/- 15%
- Air changes (per hr): 25 changes/hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: June 15, 1992 To: June 22, 1992

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated areas of same animal were used as controls
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 hrs
Observation period:
0, 24, 48, and 72 hrs, and 5 and 7 days after removal of the patches
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: 2.5 x 2.5 cm gauze pads secured by thin bands of adhesive wrap, then covered with rubberized cloth


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
0.62
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
Erythema (maximum score of 2) was seen in all animals at the 24 hr observation. In 3 of the animals, the erythema persisted throughout the experiment, and was not fully resolved by the end of the experiment on day 7. Edema was seen in one animal at the 24 hr observation only.

Any other information on results incl. tables

Results of Skin Irritation Study

Time after patch removal

Animal

Erythema

1

2

3

4

5

6

Mean

1 hr

0

0

0

0

0

0

0.00

24 hrs

2

1

2

1

1

1

1.33

48 hrs

2

1

1

1

1

1

1.17

72 hrs

1

1

1

1

1

1

1.00

5 days

1

1

1

1

1

1

1.00

7 days

0

0

1

0

1

1

0.50

Oedema

1 hr

0

0

0

0

0

0

0.00

24 hrs

1

0

0

0

0

0

0.17

48 hrs

0

0

0

0

0

0

0.00

72 hrs

0

0

0

0

0

0

0.00

5 days

0

0

0

0

0

0

0.00

7 days

0

0

0

0

0

0

0.00

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance caused only mild irritation, however, symptoms were not fully resolved by the end of the experiment.
Executive summary:

This study examined the potential of the test substance to cause skin irritation. 6 rabbits were exposed to undiluted test substance on shave skin for 4 hrs. After the exposure the animals were scored for skin irritation, and were scored again at 24, 48, and 72 after end of exposure. Since symptoms were not fully resolved, further observations were made at 5 and 7 days after end of exposure. At the 24 hr observation, all animals showed signs of erythema (maximum score of 2), and one animal showed signs of edema (score of 1). There were no signs of edema in any animal at the 48 hr observation. Erythema persisted in all animals through day 5, and in 3 of the animals, erythema was not fully resolved at the end of the experiment on day 7. Though all symptoms of irritation were mild, the irritation was not fully reversible within the study period.