Registration Dossier
Registration Dossier
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EC number: 201-337-8 | CAS number: 81-25-4
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Cholic acid
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: particulate/powder
- Reference substance:
- Cholic acid
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Refer to Section 8 of the CSR and the lead registrant dossier.
Although environmental emissions are not foreseen in view of their use as intermediate under controlled conditions, the five bile acid are considered o be readily biodegradable if released in water. Moreover, the substances are not expected to bioaccumulate and they are expected to be of low toxicity for aquatic organisms, as indicated by the short-term ecotoxicity studies on fish, crustaceans and algae.
In conclusion, considering all the available data, the substances do not meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Persistent”, “Bioaccumulative” and “Toxic”. Therefore, ursodeoxycholic acid, cholic acid, 7-ketolithocholic acid and 12-ketochenodeoxycholic acid are not considered to be neither PBT nor vPvB substances.
Reference
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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