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EC number: 700-453-0 | CAS number: 59802-05-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18.10.2010 to 26.11.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
- EC Number:
- 700-453-0
- Cas Number:
- 59802-05-0
- Molecular formula:
- C26H42O4
- IUPAC Name:
- 1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
- Test material form:
- liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Vehicle / solvent:
- DMSO (A.C.S. spectrophotometric grade)
Controlsopen allclose all
- Positive controls:
- yes
- Remarks:
- 2 μg/plate for strains TA100 and TA1535
- Positive control substance:
- sodium azide
- Remarks:
- In the absence of S9 mix
- Positive controls:
- yes
- Remarks:
- 50 μg/plate for strain TA1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- In the absence of S9 mix
- Positive controls:
- yes
- Remarks:
- 2 μg/plate for strain TA98
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- In the absence of S9 mix
- Positive controls:
- yes
- Remarks:
- 2 μg/plate for strain WP2 uvrA (pKM101)
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- In the absence of S9 mix
- Positive controls:
- yes
- Remarks:
- 5 μg/plate for strains TA100 and TA1535 10 μg/plate for strain WP2 uvrA (pKM101)
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- In the presence of S9 mix
- Positive controls:
- yes
- Remarks:
- 5 μg/plate for strains TA98 and TA1537
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- In the presence of S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
- Cell density at seeding (if applicable):at least 109 per mL
DURATION
- Exposure duration: 72 h
- Expression time (cells in growth medium):
NUMBER OF REPLICATIONS: Three - Evaluation criteria:
- For a test to be considered valid, the mean of the vehicle control revertant colony numbers for
each strain should lie within or close to the 99% confidence limits of the current historical
control range of the laboratory unless otherwise justified by the Study Director.
Also, the
positive control compounds must induce an increase in mean revertant colony numbers of at
least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle
controls. Mean viable cell counts in the 10-hour bacterial cultures must be at least 109/mL.
Results and discussion
Test results
- Key result
- Species / strain:
- bacteria, other: S.typhimurium TA1535, TA1537, TA98, TA100; E.coli WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- It is concluded that Bis(C9 (branched)alkyl) benzene-1,4-dicarboxylate showed no evidence
of mutagenic activity in this bacterial system under the test conditions employed.
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