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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
A precise discriminating dose or precise LD50 was not possible to determine based on these results.
However, based on the absence of mortality at 100 mg/kg and mortality of > 70% at 200 mg/kg, an LD can be assumed to be in the range leading to Acute Tox 3 for classification purposes.
A supporting study noted mortality of approximately 50% at approximately 840 mg/kg when dosed in the form of the plant extract. This study showed that liver is a possible target organ.
Although these research tests do not meet the criteria for modern regulatory testing and were apparently not performed to GLP, it is possible to conclude classification as Acute Tox 3. No further acute oral toxicity testing can be justified.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- 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
- Remarks:
- Part of pre-clinical research for the medical use of genipin
- Justification for type of information:
- Acute oral toxicity study on rats performed as part of pre-clinical research on metabolic processes.
Peer-reviewed published research
In view of the observed mortality, the study can be used to support classification.
No further animal testing can be justified to support acute oral toxicity - Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Two dose levels administered orally to 9 rats
The purpose of the study was to look for excretion of metabolites, but in view of mortality being observed, the study provides details to allow classification - GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Technical grade obtained from Challenae Bioproducts Co. Ltd
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Administered after 12 hours fasting
- Doses:
- 100 and 200 mg/kg single dose
- No. of animals per sex per dose:
- 9
- Control animals:
- no
- Details on study design:
- Testing was to look for metabolic activity of genipin and the crude plant extracts
Blood samples were taken frequently over the period from 5 minutes and up to 7 days dosing, with analysis performed by HLPC to detect the parent compound and probable metabolites. - Sex:
- male
- Dose descriptor:
- approximate LD50
- Remarks:
- Resulted in death of 7 out of 9 animals
- Effect level:
- 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 7 out of 9 males at 200 mg/kg
No mortality at 100 mg/kg - Clinical signs:
- other:
- Other findings:
- Blood samples taken at time points after administration showed that the sulphate form of genipin emerged rapidly in plasma, whereas the parent form of genipin was not detected. This was a clear indication that rapid and extensive sulphation had occurred during the first pass through intestine and liver
- Interpretation of results:
- Category 3 based on GHS criteria
- Remarks:
- Although a precise LD50 was not determined, it is noted that this would be between 100 and 200 mg/kg and allowing classification
- Conclusions:
- A precise discriminating dose or precise LD50 was not possible to determine based on these results.
However, based on the absence of mortality at 100 mg/kg and mortality of > 70% at 200 mg/kg, an LD can be assumed to be in the range leading to Acute Tox 3 for classification purposes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- ca. 200 mg/kg bw
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.