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Registration Dossier
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EC number: 201-304-8 | CAS number: 80-73-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 January to 2 February 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study carried out in compliance with an internationally recognised guideline
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,3-dimethylimidazolidin-2-one
- EC Number:
- 201-304-8
- EC Name:
- 1,3-dimethylimidazolidin-2-one
- Cas Number:
- 80-73-9
- Molecular formula:
- C5H10N2O
- IUPAC Name:
- 1,3-dimethylimidazolidin-2-one
- Test material form:
- other: liquid
- Details on test material:
- Batch number: 55089
Purity: 99.9%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: reputable supplier of laboratory animals
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.72 to 2.90 kg
- Housing: suspended metal cage
- Diet (e.g. ad libitum): free access to commercially available rabbit feed
- Water (e.g. ad libitum): free access to mains drinking water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 20
- Humidity (%): 50 to 65
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
IN-LIFE DATES: From: To: 28 January to 2 February 1998
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours after application
- Observation period:
- Approximately one hour, 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: not reported
- % coverage: not reported
- Type of wrap if used: cotton gauze pad secured by surgical adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 3 mis, 1 hr and 4hrs after application
SCORING SYSTEM: Draize classification scheme.
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: 72 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
4 -hour exposure period - very slight erythema was noted at all treated skin sites at the 24 and 48 -hour observations. All treated skin sites appeared normal at the 72-hour observation.
1 -hour exposure period - very slight erythema was noted at the treated skin site at the 24 -hour observation. The treated skin site appeared normal at the 48 -hour observation.
3 - minute exposure period - no evidence of skin irritation was noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria.
- Conclusions:
- The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations.
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