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Diss Factsheets
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EC number: 636-196-5 | CAS number: 6902-77-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Considered mild irritant to eye, although borderline Eye Irrit 2.
No adverse effects ot the skin following repeated administration to rabbits.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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. - 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
- Species:
- rabbit
- Strain:
- New Zealand White
- 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
- 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
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The non-standard guideline study with repeated application to the anials demonstrated no adverse effects.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Remarks:
- Performed outside the EU as part of academic medical research Published data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Performed as biological screening prior to work as medicinal product outside the EU
Published data in peer reviewed journal
Individual animal data not included in the publication - Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Performed with Draize scoring to meet GHS criteria
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- 5 males, 5 females
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- Up to 15 days post treatment
- Number of animals or in vitro replicates:
- 5 males, 5 females
- Irritation parameter:
- conjunctivae score
- Remarks:
- Includes chemosis in results
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritant / corrosive response data:
- Note that individual data has not been presented for the animals and only Draize scoring information provided. The total scores indicate borderline Eye Irrit 2 and non-classified
- Other effects:
- Not reported
- Conclusions:
- Note that individual data has not been presented for the animals and only Draize scoring information provided. The total scores indicate borderline Eye Irrit 2 and non-classified
It is noted that this in-vivo assay to verify eye irritation before conducting an in-vitro assessment on corneal repair materials was no in accordance with European ethical procedures.
However, the published data provides evidence of low irritation to eyes in terms of corneal damage, but resulted in chemosis.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.