Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-10-28 until 1997-10-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

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

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:
other: Hra:(NZW)SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc. (Denver, PA)
- Age at study initiation: young adult (at least three month old')
- Weight at study initiation: at least 200 g grams at the start of the study
- Housing: singly, in suspended, stainless-steel mesh cages. Cages and racks were washed once a week.
- Diet: Certified High Fiber Rabbit Diet (PMI #5325) was available ad libitum
- Water: municipal drinking water, regularly assayed
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18-21°C
- Humidity: 53-54 %
- Photoperiod: 12 hours of artificial light

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: test item as such (no vehicle)
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx 6 cm2
- Type of wrap if used: fiber pad and an occlusive wrap


REMOVAL OF TEST SUBSTANCE
- Washing: rinsed with running water


SCORING SYSTEM: OECD Draize - as described in OECD Guideline 405 (Annex V., Test B.4) (Grading of Skin Reaction)
- Body weights were measured on the day of initiation of the study.

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:
0
Max. score:
4
Reversibility:
other: No irritant response noted
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: No irritant response noted
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 -48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: No irritant response noted
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: No irritant response noted
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 -48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: No irritant response noted
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 -48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: No irritant response noted
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 -48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: No irritant response noted
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 -48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: No irritant response noted

Any other information on results incl. tables

Exposition:

4 h

Animal

Reading

Erythema

Edema

1

1 h

0

0

2

1 h

0

0

3

1 h

0

0

 

1

24 h

0

0

 

2

24 h

0

0

 

3

24 h

0

0

 

1

48 h

0

0

 

2

48 h

0

0

 

3

48 h

0

0

 

1

72 h

0

0

 

2

72 h

0

0

 

3

72 h

0

0

 

mean

24 - 72 h

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU