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Diss Factsheets
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EC number: 219-542-6 | CAS number: 2458-08-4
- 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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LOAEL
- 1 500 mg/kg bw/day
- Species:
- mouse
- Quality of whole database:
- Basing on a read-across approach on a similar substance (ursodeoxycholic acid), no effects on fertility have been reported by repeated dose toxicity studies and the lack of toxicity on fertility is confirmed by the developmental studies and by the high doses at which negative effects have been generally observed. The results of the QSAR study, therefore, have been considered not reliable in a weight of evidence approach. In conclusion, the provided information is considered sufficient to assess the toxicity on fertility of the substance.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Exposure of humans via inhalation is unlikely and not significant. The substance is solid with very low vapor pressure and it is only used at industrial sites by trained workers, under operative conditions not forming aerosols and dusts and under specific risk control measures (as described in the Exposure Scenarios).
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Basing on a read-across approach on the similar substance ursodeoxycholic acid, no effects on fertility have been reported by repeated dose toxicity studies and the lack of toxicity on fertility is confirmed by the developmental studies and by the high doses at which negative effects have been generally observed. The results of the QSAR study, therefore, have been considered not reliable in a weight of evidence approach.
Justification for selection of Effect on fertility via oral route:
Although the original report is not available, the toxicological database reporting the information is well recognized.
Justification for selection of Effect on fertility via dermal route:
Exposure of humans via dermal route is unlikely and not significant. The substance is only used at industrial sites by trained workers, wearing suitable protective gloves and clothes, under specific risk control measures (as described in the Exposure Scenarios).
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Species:
- rat
- Quality of whole database:
- Basing on a read across approach on a similar substance (ursodeoxycholic acid), the developmental effects of the substance have been observed only at high doses, with the exception of the effects on the offspring of rabbits, but condisering that this is the only species in which negative effects have been observed at 65 mg/kg bw/day and that the extent of the effects has not been reported, the TDLo value can be considered not relevant for the overall assessment. In conclusion, the provided information is considered sufficient to assess the developmental toxicity of the substance.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Exposure of humans via inhalation is unlikely and not significant. The substance is solid with very low vapor pressure and it is only used at industrial sites by trained workers, under operative conditions not forming aerosols and dusts and under specific risk control measures (as described in the Exposure Scenarios).
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Exposure of humans via dermal route is unlikely and not significant. The substance is only used at industrial sites by trained workers, wearing suitable protective gloves and clothes, under specific risk control measures (as described in the Exposure Scenarios).
Additional information
Basing on a read across approach on the similar substance ursodeoxycholic acid, the developmental effects of the substance have been observed only at high doses, with the exception of the effects on the offspring of rabbits, but considering that this is the only species in which negative effects have been observed at 65 mg/kg bw/day and that the extent of the effects has not been reported, the TDLo value can be considered not relevant for the overall assessment.
Justification for selection of Effect on developmental toxicity: via oral route:
The selected study provides the up-to-date and more completed information on developmental toxicity of the susbtance.
Toxicity to reproduction: other studies
Additional information
In conclusion, basing on a read-across approach, effects on fertility and development have been observed only at very high doses and, according to the study of Stìtinová V et al. (2003), the NOAELs for maternal toxicity and developmental toxicity can be established at 1000 mg/kg bw/day.
Justification for classification or non-classification
Basing on the overall data and according to Regulation 1272/2008/EC, 12-ketochenodeoxycholic acid is not considered toxic to reproduction.
Additional information
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.