Registration Dossier
Registration Dossier
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EC number: 207-481-8 | CAS number: 474-25-9
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Chenodeoxycholic acid
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: particulate/powder
- Reference substance:
- Chenodeoxycholic 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 its use as intermediate under controlled conditions, chenodeoxycholic acid is considered, to be readily biodegradable if released in water. Moreover, the substance is not expected to bioaccumulate, and it is expected to be of low toxicity for aquatic organisms, as indicated by the short-term ecotoxicity studies on fish, crustaceans and algae. Considering, however, that chenodeoxycholic acid is suspected to impair fertility and development after oral exposure in mammals, the substance is considered to meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as "Toxic".
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”, but meets the criteria for the classification as “Toxic”. Therefore, chenodeoxycholicacid is not considered to be neither PBT nor vPvB substances.
Reference
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