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Registration Dossier
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
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
“Protein binding by OASIS” and “Skin sensitization alerts implemented by Toxtree” are two profilers relevant for skin sensitization.
“Protein binding by OASIS” includes categories or chemical mechanism of protein binding particularly relevant for skin sensitization. Toxtree decision rule system identifies alerts for skin sensitization using a SMARTS pattern based approach. “Skin sensitization alerts” is based on the identification of structural alerts for skin sensitization as described in Enoch et al (Enoch SJ et al., SAR & QSAR Environ Res. 2008;19(5-6), 555-78).
According to “Protein binding by OASIS”, all the target chemicals were classified as “no binding”, since they did not answer any of the categorization criteria. No structural alerts were identified for the five biliary acids according to “Skin sensitization alerts”. In fact no alerts were identified for acyl transfer agent, nor for a potential Michael acceptor, nor for Schiff base formation, nor for potential second-order nucleophilic aliphatic substitution reaction, nor for nucleophilic aromatic substitution reaction.
Thus, it was concluded thatthe five biliary acids are NOT SKIN SENSITIZER.
Justification for selection of skin sensitisation endpoint:
“Protein binding by OASIS” and “Skin sensitization alerts implemented by Toxtree” are two validated profilers relevant for skin sensitization.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of a QSAR prediction, 12 -ketochenodeoxycholic acid is not classified for skin seinsitization, according to Regulation 1272/2008/EC.
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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