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EC number: 805-172-8 | CAS number: 65646-25-5
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6th August 2015- 23rd September 2015
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- 1,2-dipropyl cyclohexane-1,2-dicarboxylate
- EC Number:
- 805-172-8
- Cas Number:
- 65646-25-5
- Molecular formula:
- C14 H24 O4
- IUPAC Name:
- 1,2-dipropyl cyclohexane-1,2-dicarboxylate
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): CHP
- Physical state: Colourless Liquid
- Analytical purity: 98.6%
- Lot/batch No.:ST111209
- Expiration date of the lot/batch:31 December 2016
- Storage condition of test material:Room temperature (ca. 20°C), in the dark, under gaseous nitrogen
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:
- Sprague-Dawley-induced rat liver S9
- Test concentrations with justification for top dose:
- First main test with metabolic activation: 5-5000 micrograms/plate
First main test without metabolic activation: 5-5000 micrograms/plate
Second main test with metabolic activation: 50-5000 micrograms/plate
Second main test without metabolic activation: 50-5,000 micrograms/plate
Additonal main test with metabolic activation: 0.5-1500 micrograms/plate
Additonal main test without metabolic activation: 0.5-1500 micrograms/plate - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Positive controls:
- yes
- Positive control substance:
- other: 2-Nitrofluorene
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitroquinoline-1-oxide
- 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 current historical control range for the laboratory unless otherwise justified by the Study Director. The historical range is maintained as a rolling record over a maximum of five years. 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, which have relatively low spontaneous reversion rates) that of the concurrent vehicle controls. Meanviable cell counts in the 10-hour bacterial cultures must be at least 109/mL.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxicity (observed as thinning of the background lawn of non-revertant colonies, together with a reduction in revertant colony numbers) was seen in strain TA1537 following exposure to CHP at 5000 μg/plate in the presence of S9 mix.
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks on result:
- other: other: First Test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
First test Toxicity (observed as thinning of the background lawn of non-revertant colonies, together with a reduction in revertant colony numbers) was seen in strain TA1537 following exposure to CHP at 5000 μg/plate in the presence of S9 mix. A maximum exposure concentration of 5000 μg/plate was, therefore, selected for use in the second test. No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to CHP at any concentration up to and including 5000 μg/plate in either the presence or absence of S9 mix.
Second test Toxicity (observed as thinning of the background lawn of non-revertant colonies, together with a reduction in revertant colony numbers) was seen in strains TA100, TA1535 and TA1537 from 150 μg/plate in the absence of S9 mix. In strain WP2 uvrA (pKM101), toxicity (observed as a reduction in revertant colony numbers) was seen from 1500 μg/plate in the absence of S9 mix. In the presence of S9 mix, toxicity (observed as thinning of the background lawn of non-revertant colonies, together with a reduction in revertant colony numbers) was seen in strain TA1535 at 5000 μg/plate and in strain TA1537 at 500, 1500 and 5000 μg/plate. As an insufficient amount of non-toxic concentrations was obtained with strains TA100 and TA1535 without metabolic activation and with strain TA1537 with and without metabolic activation, an additional test was performed. A maximum exposure concentration of 1500 μg/plate was selected for use in the additional test. No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to CHP at any concentration up to and including 5000 μg/plate in either the presence or absence of S9 mix.
Additional test Toxicity (observed as thinning of the background lawn of non-revertant colonies and/or a reduction in revertant colony numbers) was seen in strain TA1535 from 50 μg/plate and in strains TA100 and TA1537 from 150 μg/plate in the absence of S9 mix. In the presence of S9 mix, toxicity (observed as thinning of the background lawn of non-revertant colonies) was seen in strain TA1537 at 1500 μg/plate. No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to CHP at any concentration up to and including 1500 μg/plate in either the presence or absence of S9 mix.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It was concluded that CHP showed no evidence of mutagenic activity in this bacterial system under the test conditions employed. - Executive summary:
No evidence of mutagenic activity was seen at any concentration of CHP in either mutation test. The concurrent positive controls verified the sensitivity of the assay and the metabolising activity of the liver preparations. The mean revertant colony counts for the vehicle controls were within or close to the current historical control range for the laboratory. It was concluded that CHP showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.
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