Registration Dossier
Registration Dossier
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EC number: 254-372-6 | CAS number: 39236-46-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Brief report of an open-site skin irritation study, with sufficient information to conclude an effective absence of irritation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Evaluation of irritant action on intact and abraded skin, using an open test site with immobilisation of test animals.
- GLP compliance:
- no
- Remarks:
- Pre-GLP study
Test material
- Reference substance name:
- N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]
- EC Number:
- 254-372-6
- EC Name:
- N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]
- Cas Number:
- 39236-46-9
- Molecular formula:
- C11H16N8O8
- IUPAC Name:
- N',N'''-methylenebis{1-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea}
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Described as albino rabbits.
- Details on test animals or test system and environmental conditions:
- No further information available.
Test system
- Type of coverage:
- open
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5g/test site.
- Duration of treatment / exposure:
- 24h
- Observation period:
- Skin reactions scored 24h and 72h after start of the exposure period.
- Number of animals:
- 3 rabbits
- Details on study design:
- Areas of intact and abraded (to penetrate stratum corneum only) skin were treated on each rabbit.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No signs of irritation observed.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No signs of irritation observed.
- Irritant / corrosive response data:
- No evidence of irritation was observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Open-site application of 0.5g test substance produced no evidence of skin irritation in this study.
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