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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP guideline-equivalent study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize, et. al.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-Vinylpyrrolidone (Code No. 77/757)
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraided or unabraided
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml
Duration of treatment / exposure:
24 hours
Observation period:
72 hours. If distinct reading observed after 72 hours, a final reading is taken 7 days later.
Number of animals:
6 abraded skin, 6 intact skin
Details on study design:
TEST SITE
- Area of exposure: 1 in. x 1 in.
- % coverage: not stated
- Type of wrap if used: surgical patch wrapped with impervious wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: n/a

SCORING SYSTEM:
- Erythema: 0 - 4
- Edema: 0 - 4
- Total: 8 (4 + 4)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
4
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.8
Max. score:
4
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: intact skin

Any other information on results incl. tables

Intact Skin

Rabbit No.

24-hours

72-hours

Erythema

Edema

Erythema

Edema

6792

1

0

1

0

6793

1

0

1

0

6794

1

0

0

0

6795

1

0

1

0

6796

1

0

1

0

6797

1

0

1

0

Mean

1

0

0.8

0

 

Abraded Skin

Rabbit No.

24-hours

72-hours

Erythema

Edema

Erythema

Edema

6786

4

1

4

1

6787

4

2

4

1

6788

4

1

4

1

6789

4

1

4

1

6790

4

1

4

1

6791

4

1

4

0

Mean

4

1.2

4

0.8

 

Applicant's summary and conclusion

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