Registration Dossier

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
other: Physiologically based pharmacokinetic model
Adequacy of study:
other information
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standard and well documented.

Data source

Reference
Reference Type:
publication
Title:
Physiologically based pharmacokinetic models applicable to organogenesis: extrapolation between species and potential use in prenatal toxicity risk assessments
Author:
Welsch F, Blumenthal G M, Conolly R B
Year:
1995
Bibliographic source:
Toxicol. Lett., 82/83: 539-547.

Materials and methods

Principles of method if other than guideline:
Physiologically based pharmacokinetic modei (PBPK model)
Type of method:
other: in silico

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Executive summary:

A physiologically based pharmacokinetic (PBPK) model describing the disposition of Methoxyacetic acid was developed in pregnant rodents. This model was validated with pharmacokinetic data from dams and embryos during major organogenesis. A physiological model of human pregnancy was then combined with the PBPK model and linked to an empirical Methoxyacetic acid pharmacokinetic model with two maternal compartments and a single or multiple conceptus compartment (depending on the developmental stage). This approach is intended to allow more realistic human pregnancy risk assessments.