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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:
Mar 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
Deviations:
yes
Remarks:
4 concentrations of the test substance were tested on each animal
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Remarks:
Chbb:HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: Animals were housed individually in PPL cages (45 cm x 55 cm) with perforated floor.
- Diet: Altromin 2123, pelleted complete rabbit diet (Chr. Petersen, Ringsted, Denmark), ad libitum
- Water: fresh water, ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 6
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: diethyl phthalate
Controls:
other: adjacent areas of skin treated with vehicle served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 1, 5, 25 and 100%
Duration of treatment / exposure:
4 h
Observation period:
72 h; Since all observed effects had completely reversed at the 48-h reading, the study was discontinued after the 72 h reading.
Reading time points: 30 min and 24, 48 and 72 h
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: area on the back (10 cm x 10 cm) divided into two anterior and two posterior treatment sites and one test site at the center.
- Type of wrap: The test substance of one of the test concentrations or the vehicle was applied to the skin and covered with gauze packs (2.5 cm x 2.5 cm). The gauze packs were secured with a cross of 1 cm wide adhesive tape and fixed with Scanpor tape (7.5 cm width).

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance with soap and lukewarm water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: 100%
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: 100%
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 100%
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 100%
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 4 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: at test substance concentration of 1, 5 and 25%
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: at test substance concentration of 1, 5, 25 and 100%
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: at test substance concentration of 1, 5, 25 and 100%
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: at test substance concentration of 1, 5, 25 and 100%
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: at test substance concentration of 1, 5, 25 and 100%

Any other information on results incl. tables

Table 1. Results of the skin irritation study.

Rabbit no.

Test concentration

Erythema

Individual mean values

Edema

Individual mean values

½ h

24 h

48 h

72 h

½ h

24 h

48 h

72 h

1

AL

100%

2

1

0

0

0.33

0

0

0

0

0

2

PL

100%

2

1

0

0

0.33

0

0

0

0

0

3

PL

100%

1

0

0

0

0

0

0

0

0

0

4

PR

100%

0

0

0

0

0

0

0

0

0

0

AL: Anterior left treatment site

PL: Posterior left treatment site

RP: Posterior right treatment site

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Under the conditions of this skin irritation study in rabbits the test substance was not irritating to the skin.