Registration Dossier

Administrative data

Description of key information

The predicted oral LD50 in rats is 2800 mg/kg bw. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 800 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A predicted oral LD50in rats value is available (LD50: 2800 mg/kg bw). No values are available for inhalation and dermal routes, and no experimental values have been produced, because not necessary, considering that exposure by these routes is not significant and unlikely. A subcutaneous LD50in rabbits is available in literature for the similar substance ursodeoxycholic acid and according to this value (LD50: > 2000 mg/kg bw) it can be supposed that acute dermal toxicity will be low.


Justification for selection of acute toxicity – inhalation endpoint
No experimental data was deemed necessary for inhalation route, because the substance is for professional use only and, at the workplace, suitable respiratory personal protective equipment are adopted in order to avoid workers exposure. Therefore no exposure is expected by inhalation route.

Justification for selection of acute toxicity – dermal endpoint
No experimental data was deemed necessary for dermal route, because the substance is for professional use only and, at the workplace, suitable personal protective equipment are adopted in order to avoid workers exposure. Moreover, no dermal toxicity is expected on the basis of the available data on subcutaneous acute toxicity in rabbits (LD50 > 2000 mg/kg bw), basing on a read-across approach.

Justification for classification or non-classification

In conclusion, basing on the available toxicological information, no classification for acute toxicity by oral, inhalation and dermal routes is deemed necessary for methyl 3-α,7-α-diacetoxy-12-α-hydroxy-5-β-cholan-24-oate, according to Regulation 1272/2008/EU.