Registration Dossier

Administrative data

Description of key information

Ursodeoxycholic acid, chenodeoxycholic acid, cholic acid, 7-ketolihtocholic acid and 12-ketochenodeoxycholic acid resulted potentially irritating to the skin and the eyes. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No experimental results with laboratory animals are available, but the in silico study is well documented and results are calculated according to validated prediction tools: ACD/Tox Suite and Toxtree.

Regarding skin irritation, ACD/Tox Suite predicts that the five biliary acids are POSITIVE, since monocarboxyacids without basic groups in the molecule are identified as highly probable irritants of the rabbit's skin.

Toxtree did NOT identify any structural alerts for skin irritation for the five biliary acids but, following a precautionary principle, the five biliary acids are considered POTENTIALLY IRRITANT for skin.

Regarding eye irritation, ACD/ToxSuite predicts the five biliary acids POSITIVE since carboxyacids without basic groups in the molecule are usually irritating to the rabbit's eye. Toxtree did NOT identify any structural alerts for skin irritation but, following a precautionary principle, the five biliary acids are considered POTENTIALLY IRRITANT for eyes.


Justification for selection of skin irritation / corrosion endpoint:
No experimental results with laboratory animals are available, but the in silico study is well documented and results are calculated according to validated prediction tools: ACD/Tox Suite and Toxtree.

Justification for selection of eye irritation endpoint:
No experimental results with laboratory animals are available, but the in silico study is well documented and results are calculated according to validated prediction tools: ACD/Tox Suite and Toxtree.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

According to the results of the QSAR predictions and considering that the substance is a surfactant and surfactants are known to usually produce irritation to skin, eyes and mucosa membranes, 12- ketochenodeoxycholic acid has been classified as:

Skin Irrit. 2, H315

Eye Irrit.2, H319

according to Regulation 1272/2008/EC.