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Diss Factsheets
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EC number: 444-900-5 | CAS number: 49667-22-3
- 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 cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read-across from structurally similar compound. More information on read-across can be found in endpoint summary 7.6. Study published in a peer-reviewed journal, according to scientific standards. Experimental details well documented, no OECD guideline, no explicit reference to EPA OPPTS 870.5915.
Data source
Reference
- Reference Type:
- publication
- Title:
- No information
- Author:
- Giri AK, Adhikari N & Khan KA
- Year:
- 1 996
- Bibliographic source:
- Mutat. Res., 1996, 370, 1-9
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5915 (In Vivo Sister Chromatid Exchange Assay)
- Deviations:
- yes
- Remarks:
- BrdU tablets implanted 1 h before (not after) test substance administration. Only male mice tested (5 per dose) - no justification given. Room temperature of animal facilities unusually high (28°C).
- GLP compliance:
- not specified
- Type of assay:
- sister chromatid exchange assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Substance type: pure active substance
- Physical state: solid
- Supplier: Sigma Chemical Co, St. Louis MO, USA
- Analytical purity: no data
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Division of Laboratory animals, Central Drug Res. Institute, Lucknow, India
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 30 g
- Assigned to test groups randomly: no data
- Fasting period before study: no
- Housing: five per cage, husk bedding
- Diet: Standard rodent pellet diet, Gold Mohor, Lipton India Ltd, Chandigarh, India (ad libitum)
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 28 +/- 2 °C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- other: intraperitoneal (3 dose levels); or oral (gavage) 1 dose level
- Vehicle:
- Vehicle(s)/solvent(s) used: DMSO (for i.p. application), suspension in 2% gum acacia in distilled water (for gavage application)
- Justification for choice of solvent/vehicle: solubility of the test substance
- Concentration of test material in vehicle: dose-dependent: approx. 10, 20, 40 mg/mL (i.p.), 35 mg/mL (gavage)
- Amount of vehicle (if gavage or dermal): DMSO 75 microliter/mouse for i.p., 2% gum acacia in water 0.3 mL per mouse for gavage
- Type and concentration of dispersant aid (if powder): 2% gum acacia
- Lot/batch no. (if required): no data
- Purity: no data - Duration of treatment / exposure:
- i.p. administration: 23 hours, gavage administration: 23.5 hours
BrdU: 24 hours before sacrifice
colchicine: 2 hours before sacrifice - Frequency of treatment:
- single treatment
- Post exposure period:
- none (time between administration and sacrifice: i.p. 23 hours, gavage 23.5 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
i.p. 25, 50, 100 mg/kg body weight
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
oral (gavage) 350 mg/kg body weight
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 males per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- mitomycin C
- Justification for choice of positive control(s): Preston RJ et al (1987) Mutation Res. 198: 157-165
- Route of administration: i.p. only
- Doses / concentrations: 1.5 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
i.p.: 1/10 of approx. oral LD50, since no i.p. LD50 available
oral/gavage: 1/3 of approx. oral LD50
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
- BrdU tablet (paraffin-coated, 80% of surface) implanted subcutaneously under anesthesia
- i.p. injection 1 h after tablet implantation, or gavage 1/2 h after tablet implantation
- colchicine (4 mg/kg) 22 h after tablet implantation
- sacrifice and expelling of bone marrow 2 hours later, i.e. 24 hours after tablet implantation
DETAILS OF SLIDE PREPARATION:
- hypotonic treatment: 20 min, 0.075 M KCl at 37°
- three times fixing with methanol / acetic acid 3:1
- differential staining of chromosomes on slide with fluorescence-plus-Giemsa technique
METHOD OF ANALYSIS:
- 30 second division metaphase cells (40 +/- 2 chromosomes) per animal scored for sister chromatid exchange SCE
- this is a total of 150 cells per dose scored
- randomly selected metaphase cells scored for replicative indices RI by staining pattern as first (M1), second (M2) and third (M3) division metaphases
- RI = (1*M1 + 2*M2 + 3*M3) / 100 - Evaluation criteria:
- Significant increase of SCE over control
dose-related increase
change in replicative index - Statistics:
- Student's t-test, to compare results at each dose with control
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- no mortality
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- No significant increase in sister chromatid exchange (SCE) for all doses tested, when compared to solvent control.
No significant differences in replicative index (RI), when compared to control.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test item is considered not genetic toxic in vivo. The study is considered reliable and can be used as part of read-across assessment.
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