Ursodeoxycholic acid

Endpoint summary

Description of key information

The experimental oral LD50 in rats is 4600 mg/kg bw. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

RTECS database

Qualifier:

no guideline available

Principles of method if other than guideline:

Only the LD50 value for acute oral toxicity in rats is reported.

GLP compliance:

not specified

Test type:

other: no data are available

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

4 600 mg/kg bw

Based on:

not specified

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 in rats is 4600 mg/kg bw.

Executive summary:

After oral administration to rats, the acute LD50 for ursodeoxycholic acid is 4600 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 600 mg/kg bw

Quality of whole database:

It was not possible to assess the quality of the literature study because it was not possible to consult the original study report, but the LD50 value was reported by a validated toxicological database (RTECS) and the results of the QSAR study carried out with ACD/Tox Suite confirm that the value of 4600 mg/kg bw is reliable.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

exposure considerations

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

An experimental oral LD₅₀in rats value is available from literature. The value (LD₅₀: 4600 mg/kg bw) agrees with the predicted oral LD₅₀value in rats, calculated by ACD/Tox Suite (LD₅₀: 2200 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 routesis not significant and unlikely.. A subcutaneous LD₅₀in rabbits is available in literature and according to its value (LD₅₀: > 2000 mg/kg bw) it can be supposed that acute dermal toxicity will be low.

Justification for selection of acute toxicity – oral endpoint
Although it was not possible to assess the quality of the information reported in the study, the oral LD50 value reported for rats is consistent with the predicted value of the QSAR study carried out with ACD/Tox Suite.

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).

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 ursodeoxycholic acid, according to Regulation 1272/2008/EU.