Registration Dossier
Registration Dossier
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EC number: 221-698-5 | CAS number: 3195-78-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-04-07 to 1992-04-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reliable guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-methyl-N-vinylacetamide
- EC Number:
- 221-698-5
- EC Name:
- N-methyl-N-vinylacetamide
- Cas Number:
- 3195-78-6
- Molecular formula:
- C5H9NO
- IUPAC Name:
- N-ethenyl-N-methylacetamide
Constituent 1
- Specific details on test material used for the study:
- - Lot/batch No.: HOE CG 0405 0A ZD00 0001
- Expiration date of the lot/batch: until November 1992
Test animals
- Species:
- rabbit
- Strain:
- other: Chbb:NZW (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, 7950 Biberach, Germany
- Age at study initiation: 3-5 month
- Weight at study initiation: 3.0 - 3.3 kg
- Housing: individual housing
- Diet: Altromin 2123, ad libitum and hay (15 g/day)
- Water: deionisiesed, chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/- 20%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL (treated area: 2.5 x 2.5 cm)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 min and 24,48 and 72 h and 7 days after removal of the test item.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cellulose wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tepid water
- Time after start of exposure: after 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3-7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3-7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3-7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3-7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3-7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3-7 days
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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