Registration Dossier

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Experimental results reported in peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Method for analysis of methyltetrahydrophthalic acid in urine using gas chromatography and selected ion monitoring
Author:
C.H.Lindh and B.A.G. Jonsson
Year:
1994
Bibliographic source:
J. Chromatography B (1994) 660 57-66

Materials and methods

Objective of study:
metabolism
Test guideline
Qualifier:
no guideline available
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MTHPA
- Analytical purity: >95%
- Stability under test conditions: stable
- Storage condition of test material: -20 °C
Radiolabelling:
no

Test animals

Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no details given

Administration / exposure

Vehicle:
other: urine
Details on exposure:
TEST SITE
- Time after start of exposure: 3h

Duration and frequency of treatment / exposure:
not applicable
Doses / concentrations
Remarks:
Doses / Concentrations:
30-110 ng/ml
No. of animals per sex per dose:
10 urines
Control animals:
no
Positive control:
not applicable
Details on study design:
no details given
Details on dosing and sampling:
PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify): urine

METABOLITE CHARACTERISATION STUDIES
- Method type(s) for identification: GC-FID, GC-MS
column: fused-silica capillary column (30 m x 0.25 mm I.D.)
DB-5 phase and film thickness: 0.25 µm
Injection: 250 degree C
column: 110 degree C/1 min, 6 degree C /min to 140 degree C and keeping 3 min, 40 degree C/2 min
Statistics:
no details given

Results and discussion

Preliminary studies:
no details given

Toxicokinetic / pharmacokinetic studies

Details on absorption:
In humans, the substance is taken up through the respiratory way by inhalation.
Toxicokinetic parameters
Toxicokinetic parameters:
half-life 1st: 3-6 hours

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
In humans, the substance is metabolized to the corresponding di-carboxylic acids and excreted in urine. The half-times of the urine concentration of these di-carboxylic acids were 3-6 hr.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
The half-times of the urine concentration of these di-carboxylic acids were 3-6 hr.
Executive summary:

In humans, tetrahydromethylphthalic anhydride (MTHPA) is taken up through the respiratory way by inhalation and is metabolized to the corresponding di-carboxylic acids and excreted in urine. The half-times of the urine concentration of these di-carboxylic acids were 3-6 hr.