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Diss Factsheets
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EC number: 911-418-6 | CAS number: 55965-84-9
- 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 / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Guideline 59 Nohsan No. 4200
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
Test material
- Test material form:
- other: Amber-gold liquid
- Details on test material:
- - Name of test material (as cited in study report): Kathon™ 886 MW
- Physical state: Amber-gold liquid
- Stability under test conditions: Stable at room temperature
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Rohm and Haas, Batch No. J70089
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable at room temperature
- Solubility and stability of the test substance in the solvent/vehicle: Soluble and stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Dilution in water prior to oral gavage
OTHER SPECIFICS: Purity of test material was 14.1%
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan, USA
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 21-32 g males, 20-30 g females
- Assigned to test groups randomly: Not described
- Fasting period before study: Not described
- Housing: Not described
- Diet (e.g. ad libitum): Not described
- Water (e.g. ad libitum): Not described
- Acclimation period: Not described
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Amount of vehicle (if gavage or dermal): 10 mL/kg - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: test substance in water administered by oral gavage
- Duration of treatment / exposure:
- n/a
- Frequency of treatment:
- Single oral gavage
- Post exposure period:
- 6, 24 and 48 h after treatment
Doses / concentrationsopen allclose all
- Dose / conc.:
- 30 mg/kg bw (total dose)
- Remarks:
- Based on a.i.
- Dose / conc.:
- 15 mg/kg bw (total dose)
- Remarks:
- Based on a.i.
- Dose / conc.:
- 3 mg/kg bw (total dose)
- Remarks:
- Based on a.i.
- No. of animals per sex per dose:
- 7/sex/group per time point for water control and high dose, low and mid doses had 5/sex/group per time point (6, 24 and 48 h time points), and positive control (TEM) had 5/sex/group and were sacrificed at 24 h only
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Triethylenemelamine
- Route of administration: oral gavage
- Doses / concentrations: 1.0 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Range finding test: 10, 20, 30, 40 and 50 mg a.i./kg. High mortality at 40 and 50 mg a.i./kg.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Animals were given a single oral dose of the test article at concentrations of 3, 15 or 30 mg a.i./kg and and euthanized at 6, 24 or 48 h after treatment
DETAILS OF SLIDE PREPARATION: Bone marrow cells from both femurs were centrifuged, fixed, spread on glass slides, air-dried, stained with Giemsa stain, and mounted with cover glasses.
METHOD OF ANALYSIS: For each animal, at least 50 metaphases were read and scored using a microscope. - Evaluation criteria:
- Chromosome aberrations
- Statistics:
- Not described
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- subtoxic concentrations
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 10, 20, 30, 40 and 50 mg a.i./kg
- Clinical signs of toxicity in test animals: High mortality at 40 and 50 mg a.i./kg.
Applicant's summary and conclusion
- Conclusions:
- Kathon™ 886 MW biocide was negative up to 30 mg a.i./kg (didn’t cause chromosome aberrations in bone marrow cells) in this test system.
- Executive summary:
OECD 475, US EPA 84-2 and Japan Guideline 59 Nohsan No. 4200. Adult CD-1 male and female mice were dosed with a single oral dose of the test article at concentrations of 3, 15 or 30 mg a.i./kg. Control animals received a single oral dose (vehicle) of distilled water or an i.p. injection of 1.0 mg/kg triethylenemelamine (TEM, positive control). Animals were euthanized at 6, 24 or 48 h after treatment. Positive control animals were euthanized only after 24 h of treatment. Bone marrow cells from both femurs were centrifuged, fixed, spread on glass slides, air-dried, stained with Giemsa stain, mounted with cover glasses. and read using a microscope.For each animal, at least 50 metaphases were scored. There were no significant increases in the number of aberrant cells in the treated groups relative to the control groups at any harvest time.
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.
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