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EC number: 612-975-5 | CAS number: 6225-08-7
- 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:
- 21 November 2016 to 08 May 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD guideline for testing of chemicals No. 471, “Bacterial Reverse Mutation Test”, adopted on 21st July 1997.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N-dimethylnonanamide
- EC Number:
- 612-975-5
- Cas Number:
- 6225-08-7
- Molecular formula:
- C11H23NO
- IUPAC Name:
- N,N-dimethylnonanamide
- Details on test material:
- - Name of test material (as cited in study report): N,N-Dimethylnonanamide
- Synonyme: Genagen PA
1
Method
- Target gene:
- Histidine and tryptophan locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- other: Genetic Characterization of Tester Strains, histidine & tryotophan requirement
- Metabolic activation:
- with and without
- Metabolic activation system:
- 1 mL of S9 homogenate was mixed with 9 mL of co-factor solution.
- Test concentrations with justification for top dose:
- 0.01, 0.03, 0.10, 0.31 and 1 µL /plate , based on the results of solubility, precipitation and initial cytotoxicity test
- Vehicle / solvent:
- Vehicle(s)used: DMSO
Justification for choice of vehicle: The test item at the given concentration of 50 µL/mL was miscible in dimethyl sulphoxide
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoantracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation;
DURATION
- Preincubation period: 30 minutes
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS: triplicates
- OTHER: cytotoxicity by lawn evaluation and mutagenicity by evauatimg revertant colonies - Rationale for test conditions:
- not applicable
- Evaluation criteria:
- The test will be judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 2 times the mean vehicle control value in Salmonella typhimurium strains TA98, TA100 and Escherichia coli WP2 uvrA (pKM101) or equal to or greater than 3 times the mean vehicle control value in tester strains TA1535 and TA1537In the two independent trials conducted, the test item concentrations tested resulted in no appreciable increase in the number of revertant colonies over the vehicle control.
- Statistics:
- not applicable
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: insoluble
- Precipitation:no precipitation upto tested concentration
HISTORICAL CONTROL DATA (with ranges, means and standard deviation) : Attached as Annexure 1 in study report (Page no. 32 of 35)
Applicant's summary and conclusion
- Conclusions:
- The mutagenicity of Genagen PA/ N, N-Dimethylnonanamide was investigated according to the Guideline OECD 471 (Ames Test). No mutagenic acitivity was found.
- Executive summary:
The test item, Genagen PA/ N, N-Dimethylnonanamide was evaluated for mutagenicity in Bacterial Reverse Mutation Test as per the OECD guideline for testing of chemicals No. 471, “Bacterial Reverse Mutation Test”, adopted on 21stJuly 1997.
The tester strains used in the mutation assay were Salmonella typhimurium TA98, TA100, TA1535, and TA1537 and Escherichia coli WP2 uvrA (pKM101).
The test concentrations tested in the mutation assay were selected based on the results of solubility, precipitation and initial cytotoxicity test. The two independent trials (trial 1 and 2) were conducted by plate incorporation method in the presence and absence of metabolic activation system. In mutation assay the test item was tested at the concentrations of0.01, 0.03, 0.10, 0.31 and 1 µL /plate. Vehicle control (dimethyl sulphoxide) and appropriate positive controls (2-nitrofluorene, sodium azide and 9-Aminoacridine, 4-nitroquinoline 1-oxide for trials “without metabolic activation” and 2-Aminoanthracene for trials “with metabolic activation”) were tested simultaneously.
On the basis of test item solubility and precipitation tests, the initial cytotoxicity test was performed at 1, 2, 3, 4, and 5 µL/plate. Initial cytotoxicity test was performed with TA100 both in the presence and absence of metabolic activation system.
The tester strain, TA100 treated with test item, Genagen PA/ N, N-Dimethylnonanamide at the concentration of 3, 4 and 5 µL /plate both in the presence and absence of metabolic activation revealed extremely reduced lawn (grade1+) when compared to vehicle control. Similarly, TA100 treated with test item at 2 and 1 µL/plate showed moderately reduced lawn (grade 3+) and slightly reduced lawn (grade 2+) respectively when compared to vehicle control. On the basis of cytotoxicity results 1 µL /plate was considered as the highest test concentration for mutation assay.
The results of mutation assay performed in two independent experiment (Trial 1 and 2) clearly revealed that there was no appreciable increase in the mean revertant colonies compared to those of the vehicle control, in both the trials, in the presence and absence of metabolic activation, at any of the tested concentrations.
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