Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A written assessment of toxicokinetic behaviour is considered appropriate for the substance. The substance displays only minor toxicological effects in any of the studies proposed, and is deemed to be be not harmful for health effects. As such, it is deemed inappropriate in terms of animal welfare to conduct a toxicokinetic assessment when no harmful effects are predicted based on known toxicology. A written assessment has therefore been prepared to address this endpoint.

Data source

Materials and methods

Principles of method if other than guideline:
A written assessment based on the toxicological profile of the substance.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: Bismuth trinitrate

Test animals

Species:
other: not applicable
Details on test animals and environmental conditions:
Not applicable

Administration / exposure

Route of administration:
other: not applicable
Details on exposure:
Not applicable
Duration and frequency of treatment / exposure:
Not applicable
Doses / concentrations
Remarks:
Doses / Concentrations:
Not applicable
No. of animals per sex per dose:
Not applicable
Positive control:
Not applicable
Details on study design:
Not applicable
Details on dosing and sampling:
Not applicable

Results and discussion

Preliminary studies:
Not applicable

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Not applicable
Details on distribution in tissues:
Not applicable
Details on excretion:
Not applicable

Metabolite characterisation studies

Details on metabolites:
Not applicable

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: low bioaccumulation potential based on review of study results
Executive summary:

A toxicokinetics assessment was conducted for bismuth trinitrate using available data including data from the published literature. Based on the results of this assessment, the substance is considered to have low bioaccumulation potential.

Value used for CSA:

Bioaccumulation potential: low bioaccumulation potential

Absorption rate - oral (%): 1

Absorption rate - dermal (%): 0.1 (dry exposure)

Absorption rate - inhalation (%): 1