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EC number: 234-290-7 | CAS number: 11070-44-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-12-08 to 1997-07-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines for screening Mutagenicity testing of Chemicals (Japan) and OECD Test Guideline 471 and 472
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- 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): 1,3-isobenzofurandione, tetrahydromethyl (THMBF)
- Storage condition of test material: sealed, room temperature, dark place
Constituent 1
Method
- Target gene:
- not indicated
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: provided by Dr. A. N. Ames, California University, USA on 1975-10-31
- Properly maintained: yes, -80 °C
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- - Type and identity of media: provided by Dr.Gada, National Institute of Genetics, Japan on 1979-5-9
- Properly maintained: yes, -80 °C
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- -S9 mix; 0, 62.5, 125, 250, 500, 1000, 2000 µg/plate
+S9 mix; 0, 156, 313, 625, 1250, 2500, 5000 µg/plate - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of vehicle: well-known solvent for general purpose
- Details on test system and experimental conditions:
- Type: Ames test
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS:2
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: The test substance is considered to be positive for mutagenic activity when assay plates with the test substance show a significant increase in revertant colony count as compared with that on negative control plates and when this effect is reasonably reproducible or dose dependent. - Evaluation criteria:
- no details given
- Statistics:
- no details given
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- This chemical did not induce mutations in the S. typhimurium and E. coli strains.
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: 7.4
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- Tetrahydromethylphthalic anhydride (MTHPA) was not mutagenic in Salmonella typhimuriumTA100, TA1535, TA98, TA1537 and Escherichia coli WP2uvrA at concentrations up to 5 mg/plate or 2 mg/plate, with or without an exogenous metabolic activation system, respectively.
- Executive summary:
In a reverse gene mutation assay in bacteria, strains TA100, TA1535, TA98, TA1537 of S. typhimurium and Escherichia coli Wp2 uvrA were exposed to tetrahydromethylphthalic anhydride in DMSO at concentrations of 0, 62.5, 125, 250, 500, 1000, 2000 ug/plate (-S9 mix) and 0, 156, 313, 625, 1250, 2500, 5000 ug/plate (+S9 mix) in the presence and absence of mammalian metabolic activation (S9 mix, Rat liver, induced with Phenobarbital and 5,6-benzoflavone).
Tetrahydromethylphthalic anhydride was tested up to limit concentration (5000 µg/plate). No cytotoxicity occurred. The test chemical did not induce mutations in the S. typhimurium and E. coli strains The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for the Japanese Guidelines for Screening Mutagenicity Testing Of Chemicals Test Guideline and OECD 471 and 472 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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