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Diss Factsheets
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EC number: 236-195-6 | CAS number: 13223-03-5
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented report of a guideline study conducted to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): Poly (diallyldimethyl ammonium chloride)
- Substance type: non-volatile, organic
- Physical state: aqueous solution
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Purity test date: not tested
- Lot/batch No.: EC17D9B B-08
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature, protected from light
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc, Frederick, MD
- Age at study initiation: 6-8 weeks
- Weight at study initiation:
- toxicity studies: males, 30-51 g; females, 22-30 g
- micronucleus assay: males 24-32 g; females, 20-28 g
- Assigned to test groups randomly: yes,
- Fasting period before study: no
- Housing: 5 per cage in plastic autoclavable cages with filter tops
- Diet: ad libitum (certified laboratory rodent chow)
- Water : ad libidum (tap water)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 74+/-6°F
- Humidity (%): 50 +/- 20%
- Photoperiod: 12hrs dark / 12hrs light
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- distilled water
- Details on exposure:
- Male and female ICR mice were exposed to Diallyldimethylammonium chloride (DADMAC), which was administered at a constant rate of 10 ml/kg as a single IP injection
- Duration of treatment / exposure:
- One single IP
- Frequency of treatment:
- once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
22, 43 or 85 mg/kg
Basis:
analytical conc.
- No. of animals per sex per dose:
- 15 males and 15 females per test group and vehicle. 5 males and 5 females in the positive control group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Positive control: triethylenemelamine
- Route of administration: IP
- Doses / concentrations: 0.25 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow and erythrocytes
- Details of tissue and slide preparation:
- Immediately following sacrifice, the femurs were exposed, cut just above the knee, and the bone marrow was aspirated into a syringe containing foetal bovine serum. The bone marrow cells were transferred to a capped centrifuge tube containing approximately 1 ml FBS. The bone marrow cells were pelleted by centrifugation at approximately 100 x g for five minutes and the supernatant was drawn off, leaving a small amount of serum with the remaining cell pellet. The cells were resuspended by aspiration with a capillary pipet and a small drop of bone marrow suspension was spread onto a clean glass slide. Two to four slides were prepared from each animal. The slides were fixed in methanol, stained with May-Gruenwald-Giemsa and permanently mounted. Slides were coded using a random number table by an individual not involved with the scoring process. Using medium magnification, an area of acceptable quality was selected such that the cells were well spread and stained. Using oil immersion, 1000 polychromatic erythrocytes were scored for the presence of micronuclei. The number of micronucleated normocytes in the field of 1000 polychromatic erythrocytes was enumerated. The proportion of polychromatic erythrocytes to total erythrocytes was also recorded.
- Evaluation criteria:
- The incidence of micronucleated polychromatic erythrocytes per 1000 polychromatic erythrocytes was determined for each animal and treatment group. The mean incidence of micronucleated polychromatic erythrocytes must not exceed 5/1000 polychromatic erythrocytes (0.5%) in the negative control (vehicle) The incidence of micronucleated polychromatic erythrocytes in the positive control group must be significantly increased relative to negative control (p<0.05, Kastenbaum-Bowman tables)
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No significant increase in polynucleated, polychromatic ethrocytes were observed at 24, 48 or 96 hours after dose administration in males or females.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The negative and positive controls fulfilled the requirement for determination of the valid test. Under the experimental conditions, the test substance did not increase the incidence of micronuclei in mouse bone marrow and was concluded to be negative in the micronucleus test using male and female ICR mice.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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