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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
Study period:
1998-09-08 to 1998-09-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline conform study report, GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
Statement

Test material

Constituent 1
Reference substance name:
1888-91-0
IUPAC Name:
1888-91-0
Constituent 2
Chemical structure
Reference substance name:
N-acetylhexanelactam
EC Number:
217-565-6
EC Name:
N-acetylhexanelactam
Cas Number:
1888-91-1
Molecular formula:
C8H13NO2
IUPAC Name:
N-acetylhexanelactam
Details on test material:
- Name of test material: Acetylcaprolactam
- Physical state: liquid
- Analytical purity: 100%
- Lot/batch No.: Op.2
- Expiration date of the lot/batch: December 1999
- Storage condition of test material: darkness at room temperature in fume cupboard

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0.22
Max. score:
0.33
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect obseved
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this OECD 404 study the test substance was determined to be not irritant to the skin.
Executive summary:

The primary dermal irritation of the test substance to the New Zealnd White rabbits was tested in an OECD 404 study. The test substance was administered on a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster and then fixed on the clipped dorsal region of the body. Each animal was treated with 0.5 mL of the test substance. The fixed plaster was then covered with a semi-occlusive bandage for 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30 -60 minutes as well as 24, 48 and 72 hours after removal of the patches. After 30 -60 minutes and 24 hours after removal of the plaster the animals showed sporadically very slight erythema. At 48 hours after removal of the plaster all signs of irrtation were reversible. Based on the results of this study the test substance was determined to be not irritant to the skin.