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EC number: 638-747-5 | CAS number: 1228186-17-1
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study predated formal guideline requirements and GLP but performed according to existing scientific standards. Reliabilty check by Expert Panel (American Chemistry Council Fatty Nitrogen Derivatives) passed.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- In vivo mouse micronucleus assay of ditallow dimethyl ammonium chloride (DTDMAC) for mutagenic potential (only abstract available)
- Author:
- Wong, T.K.; Thompson, E.D.
- Year:
- 1 977
- Bibliographic source:
- P&RS Division. Unpublished report BSBTS # 114
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 61783-78-8
- IUPAC Name:
- 61783-78-8
- Reference substance name:
- Ditallowalkyldimethylammonium chloride
- IUPAC Name:
- Ditallowalkyldimethylammonium chloride
- Details on test material:
- - Name of test material (as cited in study report): Ditallowdimethylammonium chloride (DTDMAC)
- Physical state: liquid
- Analytical purity: 74.1 % active in water / isopropanol
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- other: C3D2F1/J
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: physiol. saline
- Justification for choice of solvent/vehicle: recommended vehicle - Details on exposure:
- Two doses 24 hours apart; sacrifice 6 and 24 hours after second dose
- Duration of treatment / exposure:
- two single treatments 24 hours apart
- Frequency of treatment:
- two single treatments 24 hours apart
- Post exposure period:
- 6 and 24 hours respectively
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg body weight
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
50 mg/kg body weight
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
500 mg/kg body weight
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg body weight
Basis:
actual ingested
- No. of animals per sex per dose:
- 8 male mice per group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- no data
Examinations
- Tissues and cell types examined:
- bone marrow cells from both femurs
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: standard spacing
- Evaluation criteria:
- 1000 polychromatic erythrocytes scored from each mouse and micronuclei recorded
- Statistics:
- analysis of variance
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Additional information on results:
- Reliability check by ACCFND Expert Panel revealed a reliability with restriction (Klimisch 2A)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Based on the available information, ditallowdimethylammonium chloride (DTDMAC) is considered to be not mutagenic in an in vivo micronucleus test. - Executive summary:
Ditallowdimethylammonium chloride was investigated for potential mutagenic effects in an in vivo micronucleus test. Eight mice per group were used and were dosed twice within 24 hours with 0, 50, 500 or 1000 mg/kg body weight via gavage. Physiological saline was used as the control vehicle. The dosing volume was 0.2 mL per dose group. Six hours after the second dosing, one group at each dose was sacrificed. The remaining groups were sacrificed 24 hours after the second dose. Immediately after sacrifice, bone marrow cells were extracted from both femurs and processed. One thousand polychromatic erythrocytes were scored from each mouse and micronuclei were recorded. There were no statistically significant differences in the mean micronuclei of the test groups compared to the negative control group. Based on the results DTDMAC was considered negative in the in vivo micronucleus test.
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