Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Skin irritation was tested using an internal standard method (BASF test). Two White Vienna rabbits were used. One side of the back was treated for 20 h under occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid test substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: N-vinylcaprolactam, dest.

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 2.16 kg


ENVIRONMENTAL CONDITIONS
not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: unchanged (melted by 34°C), ca. 1 mL



Duration of treatment / exposure:
20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 cmx2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing: no

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: scaling, not reversible within 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: scaling, not reversible within 8 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: scaling, not reversible within 8 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: scaling, not reversible within 8 days

Any other information on results incl. tables

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h exposition will serve as approximation. Descriptive scores of the raw data have been converted to Draize numerical scores.

Applicant's summary and conclusion

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