Tetrahydro-4-methylphthalic anhydride

Basic toxicokinetics

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

Test material information

Constituent 1

Reference substance name:

Tetrahydromethylphthalic anhydride

EC Number:

234-290-7

EC Name:

Tetrahydromethylphthalic anhydride

Cas Number:

11070-44-3

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
- 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 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 (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.