Registration Dossier

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:
1994-01-17 until 1994-02-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Age at study initiation: young adult
- Weight at study initiation: 3.35 - 3.82 kg
- Housing: single
- Diet: Kliba Labordiaet 341, Klingenthalmuehle AG, Kauseraugst, CH
- Water: municipal drinking water, regularly assayed
- Acclimation period: at least 1 week

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
15 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm at the back
- Type of wrap if used: Idealbinde, Pfaelzische Verbandsstoff-Fabrik, Kaiserslautern, Germany


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol (=Polyethylenglykol) pure; Lutrol/water 1:1


SCORING SYSTEM: OECD Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: Scaling was observed, see table for details
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: Scaling was observed; see table for details
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 -48 - 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: Scaling was observed, see table for details
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
2.44
Max. score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: Scaling was observed; see table for details
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 -48 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: Scaling was observed, see table for details
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 -48 - 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: Scaling was observed, see table for details
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 -48 - 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: Scaling was observed, see table for details
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 -48 - 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: see table for details

Any other information on results incl. tables

Exposition:

4 h

Animal

Reading

Erythema

Edema

Symptoms

1

1 h

2

1

 

2

1 h

1

0

 

3

1 h

2

1

 

1

24 h

3

1

 

2

24 h

2

0

 

3

24 h

2

0

 

1

48 h

3

1

 

2

48 h

2

0

 

3

48 h

2

0

 

1

72 h

3

1

 

2

72 h

2

0

 

3

72 h

3

0

 

1

8 d

1

0

Scaling

2

8 d

1

0

Scaling

3

8 d

1

0

Scaling

1

15 d

0

0

 

2

15 d

0

0

Scaling

3

15 d

0

0

 

mean

24 - 72 h

2.44

0.33

 

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU