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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
in vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 07, 1992 - June 12, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Batch: E919140



Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SAVO-Ivanovas, Kißlegg
- Age at study initiation: about 28 weeks
- Weight at study initiation:3.24 (3.13 - 3.43) kg
- Housing: separately in special rabbit cages (manufacturer: Hulskamp, type KK 017)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: more than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 32°C
- Humidity (%): 39 - 61%

IN-LIFE DATES: From: day 1 To: day 8

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: Liquid paraffin
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g per animal
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3 (2 male & 1 females)
Details on study design:
TEST SITE
- Area of exposure: left side of the animal back (Test item), right side of the animal back (Carrier)
- Type of wrap if used: polyethylene foil, which was kept in place by a leather sleeve

REMOVAL OF TEST SUBSTANCE
- Method: wiped off
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1 hour after removal, after 24, 48, 72 hours, and then daily up to experimental day 8

SCORING SYSTEM:
Evaluation of skin reactions according to OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
In the primary skin irritation test, erythema (scores 1 and 2) was observed in all animals from days 2 until 7 of the study. The rabbits revealed also scales from days 6 until 12 of the study.

The cumulative mean scores for erythema were:
Day 1: 0.0 (1 hour)
Day 2: 1.3 (24 hours)
Day 3: 1.3 (48 hours)
Day 4: 1.0 (72 hours)

Edema have not been observed.

The control sites, treated with liquid paraffin, showed no signs of irritation.

Any other information on results incl. tables

Study design

To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of liquid paraffin to ensure good contact to the skin. Afterwards, the test material was spread onto 4 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under occlusive conditions.

The first examination of the treated skin sites followed 1 hour after removal of the patches. Then examinations were performed daily for further 7 days.

Results

In the primary skin irritation test, erythema (scores 1 and 2) was observed in all animals from days 2 until 7 of the study. The rabbits revealed also scales from days 6 until 12 of the study.

The cumulative mean scores for erythema were:

Day 1: 0.0 (1 hour)

Day 2: 1.3 (24 hours)

Day 3: 1.3 (48 hours)

Day 4: 1.0 (72 hours)

Edema have not been observed.

The control sites, treated with liquid paraffin, showed no signs of irritation.

Conclusions

According to the results of the study, for regulatory purposes there is no need for classification as the animal's individual mean scores (considering readings at 24 h, 48 h, and 72 h after patch removal) were below 2.3.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the results of the study, for regulatory purposes there is no need for classification as the animal's individual mean scores (considering readings at 24 h, 48 h, and 72 h after patch removal) were below 2.3. Thus, the test item is considered to be a skin irritant.
Executive summary:

This study was performed according to GLP and methods applied are fully compliant with OECD TG 404. According to the results of the study, for regulatory purposes there is no need for classification as the animal's individual mean scores (considering readings at 24 h, 48 h, and 72 h after patch removal) were below 2.3.