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EC number: 205-450-3 | CAS number: 141-04-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Reverse gene mutation assay was conducted in line with Guidelines for Screening Mutagenicity
Testing of Chemicals (Japan) and OECD Test Guidelines 471 and 472, using the pre-incubation
method. This study was well controlled and regarded as a key study.
Dibutyl adipate showed negative results in Salmonella typhimurium TA100, TA1535, TA98,
TA1537 and Escherichia coli WP2 uvrA at concentrations up to 5 mg/plate with or without a
metabolic activation system (MHW, 1996b).
A chromosomal aberration test in line with Guidelines for Screening Mutagenicity Testing of
Chemicals (Japan) and OECD Test Guideline 473 was conducted using cultured Chinese Hamster
lung (CHL/IU) cells. This study was well controlled and regarded as a key study. The maximum
concentration of the chemical was used within no apparent cytotoxic effect in continuous treatment.
In short term treatment, it was set to 2.6 mg/ml because the concentration was equivalent to ca. 10
mM as required in the test guidelines. Structural chromosomal aberrations were observed with
metabolic activation (MHW, 1996b).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Japanese Guideline for Screening Mutagenicity testing of chemicals
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Japanese Guideline for Screening Mutagenicity testing of chemicals
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Version / remarks:
- Japanese Guideline for Screening Mutagenicity testing of chemicals
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Cytotoxicity conc: With metabolic activation: 5000 μg/plate
Without metabolic activation: 5000 μg/plate - Details on test system and experimental conditions:
- Procedure: Plate incorporation method
Plates/test: 3
Activation system: Liver S-9 fraction from phenobarbital and
5,6-Benzoflavone pretreated male SD rats with NADPHgenerating
system
Media:Histidine selective
No. replicates: 2 - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
- Executive summary:
Reverse gene mutation assay was conducted in line with Guidelines for Screening Mutagenicity
Testing of Chemicals (Japan) and OECD Test Guidelines 471 and 472, using the pre-incubation
method. This study was well controlled and regarded as a key study.
Dibutyl adipate showed negative results in Salmonella typhimurium TA100, TA1535, TA98,
TA1537 and Escherichia coli WP2 uvrA at concentrations up to 5 mg/plate with or without a
metabolic activation system (MHW, 1996b).
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell transformation assay
- Species / strain / cell type:
- mammalian cell line, other: Chinese Hamster lung (CHL/IU)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- -S9 (continuous treatment) 0, 0.7, 1.3, 2.6 mg/ml
-S9 (short-term treatment) 0, 0.012, 0.023, 0.046 mg/ml
+S9 (short-term treatment) 0, 0.7, 1.3, 2.6 mg/ml - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- Plates/test: 2
Activation system: S-9 fraction from the liver of Phenobarbital and
5,6-Benzoflavone induced male SD derived rats with
NADPH-generating system
Media: RPMI 1640 medium plus 10% foetal calf serum plus phytohaemagglutinin
No. replicates: 1 - Key result
- Species / strain:
- mammalian cell line, other: Chinese Hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
- Executive summary:
A chromosomal aberration test in line with Guidelines for Screening Mutagenicity Testing of Chemicals (Japan) and OECD Test Guideline 473 was conducted using cultured Chinese Hamster lung (CHL/IU) cells. This study was well controlled and regarded as a key study. The maximum concentration of the chemical was used within no apparent cytotoxic effect in continuous treatment.
In short term treatment, it was set to 2.6 mg/ml because the concentration was equivalent to ca. 10 mM as required in the test guidelines. Structural chromosomal aberrations were observed with metabolic activation (MHW, 1996b).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
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