Registration Dossier
Registration Dossier
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EC number: 217-565-6 | CAS number: 1888-91-1
Skin irritation / corrosion
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:
- 1 998
- 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
- Reference substance name:
- 1888-91-0
- IUPAC Name:
- 1888-91-0
- Reference substance name:
- N-acetylhexanelactam
- EC Number:
- 217-565-6
- EC Name:
- N-acetylhexanelactam
- Cas Number:
- 1888-91-1
- Molecular formula:
- C8H13NO2
- IUPAC Name:
- 1-acetylazepan-2-one
- 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
Constituent 1
Constituent 2
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.
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