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EC number: 939-253-5 | CAS number: 68424-85-1
- 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
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- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 79/831, Annex V, Method No. 431
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- N-benzyl-N,N-dimethyltetradecan-1-aminium chloride
- EC Number:
- 939-253-5
- Cas Number:
- 68424-85-1
- Molecular formula:
- C12-14H25-29-(CH3)2-C6H5-N.Cl
- IUPAC Name:
- N-benzyl-N,N-dimethyltetradecan-1-aminium chloride
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals
- Source: Breeders were purchased from G1. Bomholtgard Ltd., but the mice used were born in the Scantox Laboratories
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 25-30g
- Assigned to test groups randomly: Yes, in groups of 5
- Fasting period before study: No
- Housing: 5 animals/cage, males and females separately in type III Macrolone cages, bedding used was special softwood sawdust "Spanvall Special White " from Spanvall Ltd., DK-4535 Vallekilde
- Diet: Complete rodent diet "Altromin 1314" from Chr. Petersen Ltd., DK-4100 Ringsted, ad libitum
- Water: Drinking water adjusted to pH 2.5 with hydrochloric acid, ad libitum
- Acclimation period:
Environmental conditions
- Temperature: 21 ±2°C
- Humidity: 55 ± 15%
- Air changes: 10/h
- Photoperiod: 12h dark /12h light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Distilled water
- Concentration of test material in vehicle: 400 mg/10 mL distilled water for the dose level of 400 mg/kg bw.
- Amount of vehicle: The vehicle was administered orally at a volume of 10 mL/kg bw. - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dilution of the test substance in distilled water
- Frequency of treatment:
- Once
- Post exposure period:
- 24, 48 and 72 h
Doses / concentrations
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide (positive control):
- Route of administration: Oral
- Doses / concentrations: 30 mg/10 mL equivalent to 30 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes
- Details of tissue and slide preparation:
- Dose selection:
Preliminary investigations:
- A few mice were treated orally with various concentrations of the test substance diluted with distilled water. Thereby the maximum tolerated dose was estimated at 400 mg/kg bw. At this dosage bone marrow smears showed a reduced number of polychromatic erythrocytes (PCE) as compared with normochromatic erythrocytes (NCE).
Details of slide preparations: Immediately after sacrifice, femurs of a mouse were dissected free of muscle, and by a 1 mL syringe with needle the bone marrow was flushed out into 5 mL of fetal calf serum. After thorough shaking, the mixture was centrifuged for 10 min. at about 1000 rpm. Thereafter, smears were made after removal of the supernatant. The specimens were fixed in methanol and stained with May-Grunwald/Giemsa.
Method of analysis: Prior to microscopic assessment, all slides were furnished with code numbers, so that the counting was blind.
The following counts were made:
Number of normochromatic erythrocytes (NCE) per 1000 erythrocytes
Number of polychromatic erythrocytes (PCE) per 1000 erythrocytes
Number of micronuclei (MN) in 1000 normochromatic erythrocytes
Number of micronuclei (MN) in 1000 polychromatic erythrocytes. - Evaluation criteria:
- Increase in the frequency of micronucleated polychromatic erythrocytes in treated animals as compared to controls
- Statistics:
- The statistical difference was analysed by one-way ANOVA. In the case of PCE (%) the test was performed on the values observed, and for the MN (per thousand) the test was done on computed rank values transformed to normal scores according to Blom's method (Blom, 1958).
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- one mortality in the 72h test group on Day 3 after treatment
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: not genotoxic
- Additional information on results:
- Results of the dose-range finding study
- Dose range: Up to 400 mg/kg bw
- Clinical signs of toxicity in test animals: Maximum tolerated dose was estimated at 400 mg/kg bw. At a dose exceeding 400 mg/kg bw, the mortality was too high.
- Evidence of cytotoxicity in tissue analyzed: At 400 mg/kg bw, bone marrow smears showed a reduced number of polychromatic erythrocytes (PCE) as compared with normochromatic erythrocytes (NCE).
Results of the main test
- Induction of micronuclei: No significant difference as compared to controls.
- Appropriateness of dose levels and route: Yes
- Statistical evaluation: Yes
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test substance did not induce an increase in the frequency of micronucleated polychromatic erythrocytes in peripheral blood samples from both male and female mice.
- Executive summary:
A study was conducted to determine the in vivo toxicity of the test substance, C12-16 ADBAC (80.2% active in ethanol) according to OECD Guideline 474, in compliance with GLP. This study was performed to evaluate the chromosome-damaging effect of the test substance in mice. The experimental animals were 50 NMRI mice, divided into 5 groups. Of the 5 groups, three were test groups, one negative control group and one positive control group. The test groups were treated with 400 mg test substance/kg bw, the negative control group with distilled water and the positive control group with 30 mg cyclophosphamide/kg bw. The mice were killed 24, 48 and 72 h, respectively after treatment. From bone marrow smears micronucleus counts were made per 1000 polychromatic erythrocytes. Under the test conditions, the test substance did not induce an increase in the frequency of micronucleated polychromatic erythrocytes in peripheral blood samples from both male and female mice (Kallesen, 1985).
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