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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 1st, 1989 - August 15th, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981's version
Deviations:
yes
Remarks:
extended to investigate 5 different concentrations of the test article and a vehicle control on each animal
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Chbb:HM
Details on test animals and environmental conditions:
TEST ANIMALS
- SPF albino female rabbits
- Weight at study initiation: between 2400 and 3000 g
- Housing: single PPL cages, 45 x 55 cm, with perforated floor
- Diet (e.g. ad libitum): ad libitum, pellets "Altromin 2123"
- Water (e.g. ad libitum): ad libitum fresh water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 55 +/- 15%
- Air changes (per hr): 6 time an hour
- Photoperiod (hrs dark / hrs light): from 6 to 18 hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Diethyl phthalate (DEP)
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100%, 50%, 25%, 5% and 1% (w/w) of test material concentrations were tested and vehicle control (0% test material, 100% DEP)
All 5 concentrations and vehicle control were applied to each rabbit.
Duration of treatment / exposure:
Test material was held in place for 4 hours and then the skin was cleaned with soap and lukewarm water.
Observation period:
First reading took place 30 minutes after removing of substance, and then at 24 hours, 48 hours, 72 hours, on day 7 and on day 14.
Number of animals:
4 rabbits were tested
Details on study design:
TEST SITE
- 6 distinct areas on the trunk of each rabbit was used to apply the different concentrations
- Type of wrap if used: test area was covered with gauze packs, 2.5 x 2.5 cm which were secured with a cross of 1 cm wide adhesive tape and fixed with Scanpor tape, 7.5 cm width, loosely wound round the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with soap and lukewarm water
- Time after start of exposure: after 4 hours exposure

SCORING SYSTEM: see table below

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
test material at 100%
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: underlying skin intact despite white to white-brown scales
Irritation parameter:
erythema score
Remarks:
test material at 50%
Basis:
mean
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
not fully reversible within: 14 days for 2 animals
Remarks on result:
other: scattered scale formation on intact skin on 2 of the animals
Irritation parameter:
erythema score
Remarks:
test material at 25%
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
test material at 5%
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Remarks:
test material at 1%
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: half an hour
Irritation parameter:
erythema score
Remarks:
vehicle control
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: half an hour
Irritation parameter:
edema score
Remarks:
test material at 100%
Basis:
mean
Time point:
24/48/72 h
Score:
2.9
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: underlying skin intact despite white to white-brown scales
Irritation parameter:
edema score
Remarks:
test material at 50%
Basis:
mean
Time point:
24/48/72 h
Score:
2.2
Max. score:
4
Reversibility:
fully reversible within: 14 days for 2 animals
Remarks on result:
other: scattered scale formation on intact skin on 2 of the animals
Irritation parameter:
edema score
Remarks:
test material at 25%
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
test material at 5%
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
test material at 1%
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: half an hour

Any other information on results incl. tables

Under the experimental conditions described in the authorized report, the mean scores for erythema in the four rabbits were as follows :

test substance concentration

100%

50%

25%

5%

1%

Vehicle

Erythema

3.0

1.6

1.0

0.3

0.0

0.0

Oedema

2.9

2.2

0.2

0.1

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
other: Skin Irrit. 2
Remarks:
according to Regulation (EC) No 1272/2008
Conclusions:
The test article (100%) and equal and above a 50% concentration shall be classified as skin irritant, whereas in concentrations of 25%, 5% and 1% shall not be classified as skin irritant.
Executive summary:

The primary skin irritant effect of the test article was investigated according to the method recommended in the OECD Guideline No. 404, "Acute Dermal Irritation/Corrosion", 1981. The study design was extended to investigate 5 different concentrations of the test article and a vehicle control on each animal.

Under the experimental conditions described in the authorized report, the mean scores for erythema in the four rabbits were as follows :

test substance concentration

100%

50%

25%

5%

1%

Vehicle

Erythema

3.0

1.6

1.0

0.3

0.0

0.0

Oedema

2.9

2.2

0.2

0.1

0.0

0.0

 

According to the Official Journal of the European Communities, L 257, 1983, the test article at 100% and equal to or above 50% concentration shall be classified as skin irritant, whereas the test article in concentrations of 25%, 5% and 1% shall not be classified as skin irritant.