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EC number: 230-939-3 | CAS number: 7378-99-6
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- The study was performed according to the AMES test methodologies but predated the current OECD 471 guideline
- Principles of method if other than guideline:
- This report describes experiments performed to assess the mutagenic activity of Farmin DM08P in two histidine-dependent strains of Salmonella typhimurium using the procedures developed by Ames et al (1975) and later refined by Maron and Ames (1983).
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dimethyl(octyl)amine
- EC Number:
- 230-939-3
- EC Name:
- Dimethyl(octyl)amine
- Cas Number:
- 7378-99-6
- Molecular formula:
- C10H23N
- IUPAC Name:
- dimethyl(octyl)amine
- Details on test material:
- Name: AD 1
Chemical Name: N, N-Dimethyloctylamine
CAS No.: 7378-99-6
Batch No.: 13602808
Expiry Date: not applicable
Physical State at Room Temperature: liquid
Colour: clear
Volatility: volatile
Density: 0.765
Molecular Weight: 157.3
Active Components: > 95%
Structure Formula of
Active Component: C8H17-N-(CH3)2
Storage Conditions: at room temperature
Constituent 1
- Specific details on test material used for the study:
- 300 g sample of Fannin DM08P, of lot No. 1318, a clear courless liquid, was received from Kao Corporation on 21 November 1995. It was stored at ambient temperature until required.
Method
- Target gene:
- rfa wall mutation, uvrB and pKM101 in Salmonella typhimurium. Tester strains TA98, TA100,
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Young male CD rats, ca. 200 g BW, were obtained from Charles River Breeding Laboratories (U.K.), Margate, Kent. Aroclor 1254 (500 mg/kg bodyweight in corn oil) was administered as a single intraperitoneal injection to induce microsomal enzyme activity.
- Test concentrations with justification for top dose:
- The maximum concentration of test material employed was selected with the aid of a preliminary toxicity test with strain TA 98.
Visible thinning of the background lawn ofnon-revertant cells was obtained following exposure to the test item at 5000 μg per plate only. This wastherefore selected as the top exposure level for use in the main tests.
Maximum dose to be plated in the presence of metabolic activation =5,000 ug per plate for both TA98 and TA100. - Vehicle / solvent:
- ethanol
Controls
- Untreated negative controls:
- yes
- Remarks:
- negative control plates confirmed the characteristically low spontaneous reversion rates of the tester strains
- Negative solvent / vehicle controls:
- yes
- Remarks:
- absence of effects of spontaneous reversionon rates when ethanol included
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- Details on test system and experimental conditions:
- A solution of Farmin DM08P was prepared in ethanol at 50 mg/ml, and four half-log dilutions were prepared from this solution. Aliquots (0.1 ml) of each concentration of Farmin DM08P were placed in sterile tubes. Molten, histidine-deficient top-agar (2 ml), maintained at 45°C, and bacterial culture (0.1 ml) were then added. The tubes were mixed by inversion and 0.5 ml rat liver microsomal preparation (S-9 mix) or O.IM phosphate buffer was added where appropriate. The tubes were again inverted to mix thoroughly and the contents poured onto plates containing solidified minimal medium (20 ml).
Further plates were prepared without the inclusion of the test organisms to verify the sterility of the S-9 mix and the test material. A control series of plates was prepared to confirm the inability of ethanol (0.1 ml) to induce reversion in the bacterial strains, and to provide a measure of the spontaneous mutation rates. Aliquots (0.1 ml) of a 10^·6 dilution of the overnight cultures were spread on
the surface of plates of complete medium to measure the viability and celldensity of each culture. All plates were prepared in duplicate, allowed to solidify and incubated at 37°C for 2 days. After incubation, numbers ofrevertant colonies were counted, either manually or with an automated colony counter. Total colonies on nutrient plates were counted in the same way. Growth of the background lawn of non-revertant cells on minimal plates was verified.
All plates and tubes were identified by the use of numbers indelibly marked on the plates and test tube racks. - Evaluation criteria:
- The plates were incubated at 3 7°C for 2 days and were then examined for the presence of a background lawn of non-revertant colonies; toxicity of the test material is shown by absence or thinning of the background lawn. The level oftest material chosen as the top level for pour-plate tests is normally the lowest level causing visible thinning of the lawn. (In the absence of such thinning, a top level of 5 mg/plate would be selected).
- Statistics:
- For all replicate platings, the mean number of revertants per plate was calculated
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:
- not specified
- 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:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test material, Farmin DM08P, did not exhibit any mutagenic activity under the conditions of test.
- Executive summary:
The material Farmin DM08P was examined for mutagenic activity in two histidinedependent auxotrophs of Salmonella typhimurium, strains TA 98 and TA 100, using pour-plate assays.
The studies, which were conducted in the presence and absence of an activating system derived from rat liver (S-9 mix), employed a range of levels of Farmin DM08P from 50 to 5000 μg per plate, selected following a preliminary toxicity test in strain TA 98. The tests included solvent (ethanol) controls with and without S-9 mix.
No increases in reversion to prototrophy were obtained with either of the bacterial strains at the Farmin DM08P levels tested, either in the presence or absence of S-9 mix.
Inhibition of bacterial growth, observed as slight thinning of the background lawn of non-revertant cells and reduction in revertant colony numbers, occurred in both strains following exposure to Farmin DM08P at 5000 μg per plate.
Marked increases in the number of revertant colonies were induced by the known mutagens benzo[a]pyrene, 2-nitrofluorene and sodium azide when examined under similar conditions.
It was concluded that Farmin DM08P did not exhibit any mutagenic activity under the conditions of test.
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