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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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
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

Constituent 1
Chemical structure
Reference substance name:
1-vinylhexahydro-2H-azepin-2-one
EC Number:
218-787-6
EC Name:
1-vinylhexahydro-2H-azepin-2-one
Cas Number:
2235-00-9
Molecular formula:
C8H13NO
IUPAC Name:
1-vinylazepan-2-one
Details on test material:
- Name of test material: N-vinylcaprolactam, dest.

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system 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