Registration Dossier
Registration Dossier
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EC number: 636-196-5 | CAS number: 6902-77-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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:
- Part of a wider assessment of the toxicity of genipin for academic research to support use in medical applications. Certain details on methods and individual observations not in the publication.
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 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Claimed to follow international guidelines
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
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
- Specific details on test material used for the study:
- Freeze dried
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Duration of exposure:
- Test material not washed off. Observation for 14 days after treatment
- Doses:
- Single dose, 2000 mg/kg
- No. of animals per sex per dose:
- Apparently 5 male and 5 female (at least 10 animals in total)
- Control animals:
- not specified
- Details on study design:
- Animals were shared prior to application
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No adverse effects
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- No adverse effects
- Gross pathology:
- No adverse effects
- Other findings:
- No adverse effects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Although not all details are provided in the publication, the result demonstrates an absence of adverse effects following dermal treatment.
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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