Registration Dossier
Registration Dossier
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EC number: 636-196-5 | CAS number: 6902-77-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- Non-EU study performed for research into use in skin repair matrices Genipin is used as a crosslinking aid in skin repair matrix for plastic surgery
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Study performed as part of academic research using non-regulatory systems
Considered suitable for classification.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Claimed to follow key parts of guidelines, but study was done with repeated 6 hour contact under occlusive dressings.
- Principles of method if other than guideline:
- Claimed to be in line with international guidelines in terms of animal handling, but study involved repeated application so the animals over 14 days
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Genipin
- EC Number:
- 636-196-5
- Cas Number:
- 6902-77-8
- Molecular formula:
- C11H14O5
- IUPAC Name:
- Genipin
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- Applied without vehicle
Amount applied not specified - Duration of treatment / exposure:
- 14 days
- Observation period:
- 14 days
- Number of animals:
- Not specified. At least 6
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Note that the animals were subject to daily treatment for 14 days with no indication of adverse effects
- Irritant / corrosive response data:
- No adverse effects
- Other effects:
- No adverse effects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The non-standard guideline study with repeated application to the anials demonstrated no adverse effects.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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