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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A well documented publication. However, the study was not conducted in accordance with the OECD guideline or with the GLP Regulation.

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

Constituent 1
Chemical structure
Reference substance name:
Tetrahydromethylphthalic anhydride
EC Number:
234-290-7
EC Name:
Tetrahydromethylphthalic anhydride
Cas Number:
11070-44-3
Molecular formula:
C9H10O3
IUPAC Name:
3a-methyl-3a,4,5,6-tetrahydro-2-benzofuran-1,3-dione
Details on test material:
- Name of test material (as cited in study report): MTHPA
- 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 or test system 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 / concentration:
10 urines
Control animals:
no
Positive control reference chemical:
not applicable
Details on study design:
no details given
Details on dosing and sampling:
PHARMACOKINETIC STUDY
- Tissues and body fluids sampled: 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 dicarboxylic acids and excreted in urine. The half-times of the urine concentration of these dicarboxylic 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 dicarboxylic 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.