Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Sep - 14 Oct 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study (reversibility of the effects was observed only up to 7 days after removal of the patches)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
National Board of Health, BronshØj, Denmark

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Mol:Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: MØllegaard Breeding and Research Centre A/S, Lille Skensved, Denmark
- Weight at study initiation: 2.3-2.5 kg
- Housing: individually in PPO/HIPS cages (2576 cm²) with perforated floor
- Diet: Altromin 2123, pelleted complete rabbit diet (Chr. Petersen, Ringsted, Denmark), ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: 1:1 (w/w) ethanol/diethylphthalate
Controls:
other: adjacent areas of skin treated with vehicle served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 5, 10, 25, 50 and 100%
Duration of treatment / exposure:
4 h
Observation period:
7 days
Reading time points: 1, 24, 48 and 72 h
Number of animals:
4 females
Details on study design:
TEST SITE
- Area of exposure: Appropriate test site on the back (10 cm x 10 cm) divided into two anterior, two centrally and two posterior located test sites. The different test concentrations were applied to the different skin areas simultaneously.
- Type of wrap: The test substance of one of the test concentrations or the vehicle was applied to the skin, using gauze patches of 2.5 cm x 2.5 cm. The patches were secured with 2.5 cm wide adhesive tape and fixed with Scanpor tape (5 cm width). Thereafter Nobifix (6 cm width) was loosely wound round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance using lukewarm water and mild soap.
- 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, #2 and #4
Time point:
other: mean after 24/48/72 h
Score:
2
Max. score:
4
Reversibility:
no data
Remarks on result:
other: test concentration: 100%
Irritation parameter:
erythema score
Basis:
animal: #3
Time point:
other: mean after 24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
no data
Remarks on result:
other: test concentration: 100%
Irritation parameter:
edema score
Basis:
animal: #1, #2 and #4
Time point:
other: mean after 24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
no data
Remarks on result:
other: test concentration: 100%
Irritation parameter:
edema score
Basis:
animal: #3
Time point:
other: mean after 24/48/72 h
Score:
2
Max. score:
4
Reversibility:
no data
Remarks on result:
other: test concentration: 100%
Irritant / corrosive response data:
None to well-defined skin reactions were seen at the test sites with 25, 50 and 100% test substance.
None to slight skin reactions were seen at the test sites with vehicle and with 10% test substance. No skin reactions were seen at the test sites with 5% test substance.
On Day 8 scabs were observed in animal No. 1 at the test sites with 25% and 50% test substance, and in animal No. 2 at the test site with 25% test substance.
On Day 8 few scattered scabs were observed in animal No. 1 at the test site with 10% test substance.
On Day 8 crust was observed in animal No. 1 at the test site with 100% test substance and in animal No. 2, 3 and 4 at the test sites with 50% and 100% test substance.
The skin of the other test fields was intact on Day 8.

Any other information on results incl. tables

Table 1. Results of the skin irritation study.

Rabbit no.

Test concentration

Erythema

Individual mean values (mean after 24/48/72 h)

Edema

Individual mean values (mean after 24/48/72 h)

1 h

24 h

48 h

72 h

1 h

24 h

48 h

72 h

1

LA

100%

1

2

2

2

2.0

1

1

2

2

1.7

RA

50%

1

2

2

2

2.0

1

1

2

2

1.7

LM

25%

1

2

2

2

2.0

1

1

2

2

1.7

RM

10%

1

1

1

1

1.0

1

1

1

1

1.0

LP

5%

0

0

0

0

0.0

0

0

0

0

0.0

RP

V%

0

0

0

0

0.0

0

0

0

0

0.0

2

LA

50%

1

2

2

2

2.0

1

1

2

2

1.7

RA

25%

1

2

2

2

2.0

1

1

2

2

1.7

LM

10%

1

1

1

1

1.0

1

1

1

1

1.0

RM

5%

0

0

0

0

0.0

0

0

0

0

0.0

LP

V

0

0

0

0

0.0

0

0

0

0

0.0

RP

100%

1

2

2

2

2.0

1

1

2

2

1.7

3

LA

25%

1

1

2

2

1.7

1

1

1

1

1.0

RA

10%

1

1

0

0

0.3

1

1

0

0

0.3

LM

5%

0

0

0

0

0.0

0

0

0

0

0.0

RM

V

0

0

0

0

0.0

0

0

0

0

0.0

LP

100%

2

2

2

3

2.3

2

2

2

2

2.0

RP

50%

1

2

2

3

2.3

1

1

2

2

1.7

4

LA

10%

1

1

0

0

0.3

1

1

0

0

0.3

RA

5%

0

0

0

0

0.0

0

0

0

0

0.0

LM

V

0

1

1

1

1.0

0

0

0

0

0.0

RM

100%

1

2

2

2

2.0

1

1

2

2

1.7

LP

50%

1

2

2

2

2.0

1

1

2

2

1.7

RP

25%

1

2

2

2

2.0

1

1

1

1

1.0

LA: Left anterior treatment site

RA: Right anterior treatment site

LM: Left middle treatment site

RM: Right middle treatment site

LP: Left posterior treatment site

RP: Right posterior treatment site

V: Vehicle (1:1 (w/w) ethanol/diethylphthalate)

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this skin irritation study the test substance was irritating to the skin.