Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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)

Test material

Constituent 1
Chemical structure
Reference substance name:
Methoxyacetic acid
EC Number:
210-894-6
EC Name:
Methoxyacetic acid
Cas Number:
625-45-6
Molecular formula:
C3H6O3
IUPAC Name:
2-methoxyacetic acid
Constituent 2
Reference substance name:
2-methoxyacetic acid
IUPAC Name:
2-methoxyacetic acid

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.