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EC number: 603-333-5 | CAS number: 129423-55-8
- 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:
- 05May2021 - 24Jun2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 26Jun2020
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- adopted 30 May 2008
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,12-bis(2-octyldodecyl) dodecanedioate
- EC Number:
- 603-333-5
- Cas Number:
- 129423-55-8
- Molecular formula:
- C52 H102 O4
- IUPAC Name:
- 1,12-bis(2-octyldodecyl) dodecanedioate
- Reference substance name:
- Dodecanedioic acid
- EC Number:
- 211-746-3
- EC Name:
- Dodecanedioic acid
- Cas Number:
- 693-23-2
- Molecular formula:
- C12H22O4
- IUPAC Name:
- dodecanedioic acid
- Reference substance name:
- 2-octyldodecan-1-ol
- EC Number:
- 226-242-9
- EC Name:
- 2-octyldodecan-1-ol
- Cas Number:
- 5333-42-6
- Molecular formula:
- C20H42O
- IUPAC Name:
- 2-octyldodecan-1-ol
- Reference substance name:
- Mono-octyldodecyl Dodecanedioate
- Molecular formula:
- C32H79O4
- IUPAC Name:
- Mono-octyldodecyl Dodecanedioate
- Test material form:
- liquid
- Details on test material:
- Name: Dioctyldodecyl Dodecanedioate
Batch no.: P-4697
CAS no.: 129423-55-8
Storage room temperature: 20 ± 5 °C
Expiry date (retest date): 05/08/2021
Stability: stable under storage conditions
Appearance: clear, colourless liquid
Purity: 100%
Homogeneity: homogeneous
Production date: 25/09/2019
Molecular weight: 791 g/mol
Constituent 1
impurity 1
impurity 2
impurity 3
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:
- benzo(a)pyrene
- Test concentrations with justification for top dose:
- Plate incorporation method: 5, 1.5, 0.5, 0.15 and 0.05 μL/plate.
Pre-incubation method: 5, 2.5, 1.25, 0.63, 0.31 ,0.16 and 0.08 μg/plate. - Vehicle / solvent:
- Acetone
Based on the non-GLP pre-test, acetone was chosen as vehicle, because the test item was sufficiently soluble, and this solvent does not have any effects on the viability of the bacteria or the number of spontaneous revertants in the tested concentrations.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- spontaneous revertant rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethylsulfoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without S9 mix for 20µg plate for TA98
Without S9 mix for 30µg plate for TA1537
- Untreated negative controls:
- yes
- Remarks:
- spontaneous revertant rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethylsulfoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- With S9 mix for 20 µg/plate for TA98
- Untreated negative controls:
- yes
- Remarks:
- spontaneous revertant rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Demin Water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Without S9 mix for 1.8µg/plate for TA100
Without S9 mix for 1µg/plate for TA1535
- Untreated negative controls:
- yes
- Remarks:
- spontaneous revertant rates
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethylsulfoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- With S9 mix for 1µg/plate for TA100
With S9 mix for 1µg/plate for TA1535
With S9 mix for 2.4µg/plate for TA1537
With S9 mix for 50µg/plate for E. Coli
- Untreated negative controls:
- yes
- Remarks:
- spontaneous revertant rates
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Without S9 mix for 2µg/plate for E. coli
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
Per bacteria strain and concentration, three plates with (+S9) and three plates without metabolic activation (-S9) were used.
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable):
- Test substance added in medium; in agar (plate incorporation);
preincubation;
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 mins
- Exposure duration/duration of treatment: 48 hrs
- Harvest time after the end of treatment (sampling/recovery times):
FOR GENE MUTATION:
- Number of cells seeded and method to enumerate numbers of viable and mutants cells: at least 109 bacteria/mL (correlating to 100 colo-nies/plate after dilution),
- Criteria for small (slow growing) and large (fast growing) colonies:
METHODS FOR MEASUREMENT OF CYTOTOXICITY
The bacterial background lawn was visible and not affected. The number of revertant colo-nies was not reduced. Thus, no signs of toxicity towards the bacteria strains could be ob-served.
METHODS FOR MEASUREMENTS OF GENOTOXICIY
- OTHER:
Sterility was examined - Evaluation criteria:
- A biologically relevant increase is described as follows:
if in the bacteria strains S. typhimurium TA98, TA100 and E. coli WP2 the number of revertants is at least twice as high than the reversion rate of the negative controls (increase factor of at least 2.0)
if in the bacteria strains S. typhimurium TA1535 and TA1537 the number of re-vertants is at least three times higher than the reversion rate of the negative con-trols (increase factor of at least 3.0). - Statistics:
- standard deviation
Results and discussion
Test resultsopen allclose all
- 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:
- valid
- Untreated negative controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2
- 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:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that Dioctyldodecyl Dodecanedioate is not mutagenic in the Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and E. coli WP2 in the presence and absence of meta-bolic activation under the experimental conditions in this study.
- Executive summary:
Based on the results of this study it is concluded that Dioctyldodecyl Dodecanedioate is not mutagenic in the Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and E. coli WP2 in the presence and absence of meta-bolic activation under the experimental conditions in this study.
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