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EC number: 932-121-8 | CAS number: 1147459-12-8
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 07, 2009 - December 24, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant and according to guidelines stated.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Please see below
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- Please see below
- Principles of method if other than guideline:
- - on one occasion, the test item was stored without nitrogen gas for about 2 hours. Based on information supplied by the Sponsor, this deviation was not considered to have compromised the validity or integrity of the study,
- the cultures were put into 13 mL of nutrient broth (as described in CIT’s SOP) instead of 6 mL. This minor deviation was not considered to have compromised the validity or integrity of the study,
- the overlay agar was maintained at 50°C instead of 45°C. This minor deviation was not considered to have compromised the validity or integrity of the study. - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl] C 12-C18 alkylamide
- EC Number:
- 932-121-8
- Cas Number:
- 1147459-12-8
- Molecular formula:
- UVCB substance not applicable
- IUPAC Name:
- N-[3-(dimethylamino)propyl] C 12-C18 alkylamide
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Coco amidopropyldimethylamine
- Substance type: Amides, C12-18 (even numbered), N-[3-(dimethylamino)propyl]
- Physical state: Light brown, paste to solid
- Analytical purity: 99.1%
Free dimethyl amino propylamine 0.4%
Free fatty acid 0.5%
- Purity test date: 31 August 2009
- Lot/batch No.: S001824
- Expiration date of the lot/batch: 2nd July 2019
- Storage condition of test material: At room temperature, under nitrogen gas, in a dry and well-ventilated room
- Other: Kept in two transparent glass flasks.
Constituent 1
Method
- Target gene:
- No details supplied
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- The day before treatment, cultures were inoculated from frozen permanents: a scrape was taken under sterile conditions and put into approximately 6 mL of nutrient broth. The nutrient broth was then placed under agitation in an incubator at 37°C for about 14 hours, to produce bacterial suspensions.
- Additional strain / cell type characteristics:
- other: Each strain derived from Salmonella typhimurium LT 2 contains one mutation in the histidine operon, resulting in a requirement for histidine. Please see materials and methods for more information
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 metabolic activation system
- Test concentrations with justification for top dose:
- The test item was dissolved in the vehicle at concentrations of:
100 mg/mL for the preliminary toxicity test,
10 mg/mL for the first experiment,
10, 5 and 1 mg/mL for the second experiment,
5 mg/mL for the third experiment. - Vehicle / solvent:
- The vehicle was dimethylsulfoxide (DMSO), batch Nos. K39250750841 and K39250750906 (VWR, Fontenay Sous Bois, France).
Controlsopen allclose all
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- The vehicle control was tested both with and without S9 mix
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- Dissolved in dimethylsulfoxide to check the sensitivity of the test system
- Positive control substance:
- sodium azide
- Remarks:
- without S9 mix. Used on the TA 1535 and TA 100 strains. Migrated to IUCLID6: 1 µg/plate
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- The vehicle control was tested both with and without S9 mix
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- Dissolved in dimethylsulfoxide to check the sensitivity of the test system
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix. Used on the TA 1537 strain. Migrated to IUCLID6: 50 µg/plate
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- The vehicle control was tested both with and without S9 mix
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- Dissolved in dimethylsulfoxide to check the sensitivity of the test system
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9 mix. Used on the TA 98 strain. Migrated to IUCLID6: 0.5 µg/plate
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- The vehicle control was tested both with and without S9 mix
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- Dissolved in distilled water to check the sensitivity of the test system
- Positive control substance:
- mitomycin C
- Remarks:
- without S9 mix. Used on the TA 102 strain. Migrated to IUCLID6: 0.5 µg/plate
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- The vehicle control was tested both with and without S9 mix
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- Dissolved in dimethylsulfoxide to check the sensitivity of the test system
- Positive control substance:
- other: 2-Anthramine
- Remarks:
- with S9 mix. 2 µg/plate was used for TA 1535, TA 1537 and TA 98 strains. 10 µg/plate was used for TA 102 strain.
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- The vehicle control was tested both with and without S9 mix
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- Dissolved in dimethylsulfoxide to check the sensitivity of the test system
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9 mix. Used for the TA 102 strain Migrated to IUCLID6: 5 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
The preliminary test, all experiments without S9 mix and the first experiment with S9 mix were performed according to the direct plate incorporation method. The second experiment with S9 mix was performed according to the preincubation method.
The direct plate incorporation method was performed as follows: test item solution (0.05 mL), S9 mix when required or phosphate buffer pH 7.4 (0.5 mL) and bacterial suspension (0.1 mL) were mixed with 2 mL of overlay agar (containing traces of the relevant aminoacid and biotin and maintained at 45°C). After rapid homogenization, the mixture was overlaid onto a Petri plate containing minimum medium.
The preincubation method was performed as follows: test item solution (0.05 mL), S9 mix (0.5 mL) and the bacterial suspension (0.1 mL) were incubated for 60 minutes at 37°C, under shaking, before adding the overlay agar and pouring onto the surface of a minimum agar plate. After 48 to 72 hours of incubation at 37°C, revertants were scored with an automatic counter (Cardinal counter, Perceptive Instruments, Suffolk CB9 7 BN, UK). Manual counting was used as needed.
DURATION
- Preincubation period: 60 minutes at 37°C
- Exposure duration: 48 to 72 hours of incubation at 37°C
NUMBER OF REPLICATIONS:
In two independent experiments, using three plates/dose-level, each strain was tested, with and without S9 mix, with:
at least five dose-levels of the test item, the vehicle control, the appropriate positive control.
In a third experiment, using three plates/dose-level, the TA 1537 strain was tested without S9 mix, with:
at least five dose-levels of the test item,
the vehicle control,
the appropriate positive control.
The sterility of the S9 mix was checked before the beginning and at the end of each experiment and was found to be satisfactory.
DETERMINATION OF CYTOTOXICITY
- Method: other: Number of revertants per plate were scored. - Evaluation criteria:
- Acceptance criteria:
This study is considered valid if the following criteria are fully met:
- the number of revertants in the vehicle controls is consistent with the historical data of the testing facility,
- the number of revertants in the positive controls is higher than that of the vehicle controls (at least 2-fold increase for the TA 98, TA 100 and TA 102 strains and at least 3-fold increase for the TA 1535 and TA 1537 strains) and is consistent with the historical data of the testing facility.
Evaluation criteria:
A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained. - Statistics:
- Not relevant
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The sterility of the test item (stock preparation) was checked and found satisfactory.
Preliminary test:
The test item was freely soluble in the vehicle (DMSO) at 100 mg/mL. Consequently, with a treatment volume of 50 µL/plate, the selected dose-levels were 10, 100, 500, 1000, 2500 and 5000 µg/plate.
A moderate precipitate was observed in the Petri plates when scoring the revertants at 5000 µg/plate without S9 mix and a moderate to strong precipitate was noted at dose-levels ≥ 1000 µg/plate with S9 mix.
A strong toxicity was noted in the three strains at dose-levels ≥ 100 µg/plate without S9 mix and ≥ 500 µg/plate with S9 mix.
Mutagenicity Experiments:
The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
Since the test item was toxic in the preliminary test, the choice of the highest dose-level was based on the level of toxicity, according to the criteria specified in the international guidelines.
Experiments without S9 mix
The selected treatment-levels were:
3.13, 6.25, 12.5, 25, 50 and 100 µg/plate for all the strains in the first experiment,
1.56, 3.13, 6.25, 12.5, 25 and 50 µg/plate for all the strains in the second experiment,
6.25, 12.5, 18.8, 25, 37.5 and 50 µg/plate for the TA 1537 strain in the third experiment.
No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels.
A moderate to strong toxicity was noted at dose-levels ≥ 25 µg/plate in the TA 100 and TA 102 strains and ≥ 50 µg/plate in the TA 1535, TA 1537 and TA 98 all strains.
A slight increase in the number of revertants, exceeding the threshold of 3-fold the corresponding vehicle control value, was noted in the second experiment in the TA 1537 strain. This increase was not considered to be biologically relevant as it was not observed in the first experiment and was not reproduced in the third experiment.
The test item did not induce any noteworthy increase in the number of revertants, in any of the other four strains.
Experiments with S9 mix
The selected treatment-levels were:
15.6, 31.3, 62.5, 125, 250 and 500 µg/plate for all the strains in the first experiment,
7.81, 15.6, 31.3, 62.5, 125 and 250 µg/plate for all the strains in the second experiment.
No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels.
A moderate to strong toxicity was noted at dose-levels ≥ 62.5 μg/plate in the TA 102 strain, ≥ 125 μg/plate in the TA 1537, TA 98 and TA 100 strains and ≥ 250 μg/plate in the TA 1535 strain. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The test item did not induce any noteworthy increase in the number of revertants, in any of the five strains.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions, the test item Cocoamidopropyldimethylamine did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium. Based on these results, the test item does not require classification according to Directive 67/548/EEC or Regulation EC No. 1272/2008. - Executive summary:
The objective of this study was to evaluate the potential of the test item Cocoamidopropyldimethylamine to induce reverse mutation in Salmonella typhimurium.
The study was performed according to the international guidelines (OECD 471 and Commission Directive No. B13/14) and in compliance with the principles of Good Laboratory Practice.
Methods
A preliminary toxicity test was performed to define the dose-levels of Cocoamidopropyldimethylamine to be used for the mutagenicity study. The test item was then tested in three independent experiments, with and/or without a metabolic activation system, the S9 mix, prepared from a liver post‑mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
All experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the preincubation method (60 minutes, 37°C).
Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to at least five dose-levels of the test item (three plates/dose‑level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored.
The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
The test item Cocoamidopropyldimethylamine was dissolved in dimethylsulfoxide (DMSO).
The dose-levels of the positive controls were as follows:
without S9 mix
- 1 µg/plate of sodium azide (NaN3): TA 1535 and TA 100 strains,
- 50 µg/plate of 9-Aminoacridine (9AA): TA 1537 strain,
- 0.5 µg/plate of 2-Nitrofluorene (2NF): TA 98 strain,
- 0.5 µg/plate of Mitomycin C (MMC): TA 102 strain.
with S9 mix
- 2 µg/plate of 2-Anthramine (2AM): TA 1535, TA 1537 and TA 98 strains,
- 5 µg/plate of Benzo(a)pyrene (BAP): TA 100 strain,
- 10 µg/plate of 2-Anthramine (2AM): TA 102 strain.
Results
The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
Since the test item was toxic in the preliminary test, the choice of the highest dose-level was based on the level of toxicity, according to the criteria specified in the international guidelines.
Experiments without S9 mix
The selected treatment-levels were:
- 3.13, 6.25, 12.5, 25, 50 and 100 µg/plate for all the strains in the first experiment,
- 1.56, 3.13, 6.25, 12.5, 25 and 50 µg/plate for all the strains in the second experiment.
No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels.
A moderate to strong toxicity was noted at dose-levels ≥ 50 µg/plate instrains.
The test item did not induce any increase in the number of revertants, which could be considered as biologically relevant, in any of the five strains.
Experiments with S9 mix
The selected treatment-levels were:
- 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate for all the strains in the first experiment,
- 7.81, 15.6, 31.3, 62.5, 125 and 250 µg/plate for all the strains in the second experiment.
No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels.
A moderate to strong toxicity was noted at dose-levels ≥ 125 µg/plate in the TA 102 strain, ≥ 125 µg/plate in the TA 1537, TA 98 and TA 100 strains and ≥ 250 µg/plate in the TA 1535 strain.
The test item did not induce any noteworthy increase in the number of revertants, in any of the five strains.
Conclusion
Under our experimental conditions, the test item Cocoamidopropyldimethylamine did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.
Under the conditions of this study, the test substance was not considered to be mutagenic and as such, does not require classification according to Regulation EC No. 1272/2008 and Directive 67/548/EEC.
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