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EC number: 414-490-2 | CAS number: 154212-59-6
- 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: other: clastogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct 17 1996 - Feb 19 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD Method and EU method in accordance with GLP. Study material is well characterized
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- Genetic toxicology micronucleus test
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- -
- EC Number:
- 414-490-2
- EC Name:
- -
- Cas Number:
- 154212-59-6
- Molecular formula:
- C11H9ClN2O5S
- IUPAC Name:
- 4-nitrophenyl (1,3-thiazol-5-yl)methyl carbonate hydrochloride
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Crl:CD-1®(ICR)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Range finding
TEST ANIMALS
- Age at study initiation: ~8 wks at the start of treatment.
- Weight at study initiation: 30 - 38g, males; 22 - 27g females.
- Assigned to test groups randomly: yes
- Fasting period before study: 30 minutes
- Housing: Individualy housed in metal hanging cages
- Diet: Certified Rodent Chow® ad libitum
- Water: tap water sd libitum
- Acclimation period: ~1 week
E NVIRONMENTAL CONDITIONS
- Temperature (°F): 70- 72
- Humidity (%): ambient
- Photoperiod (hrs dark / hrs light):12hr daily light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Propylene glycol:Ethanol :: 95:5 v/v
- Details on exposure:
- Main study Doses of test material: 600, 1200 and 2400 mg/kg were selected based on an oral LD50 of >2400mg/kg
Dosages given at a volume of 8ml/kg - Duration of treatment / exposure:
- The mice were dosed once. Bone marrow from 50% of the mice (and all the positive control mice) was harvested 24hrs after the treatment. Bone marrow was harvested from the remaining 50% 48hrs afteer treatment.
- Post exposure period:
- Individual body weights were recorded for each mouse on the day of treatment. Observations on the physical condition of all treated mice were made a minimum of twice daily during the treatment period.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Basis:
nominal conc.
0, 600, 1200, 2400mg/kg
- No. of animals per sex per dose:
- 10 males and 10 females for each of the 0 (vehicle),600, 1200 and 2400mg/kg doses. 5 males and 5 females for the 50mg/kg cyclophosphamide dose.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- A positve control group of 5 males and 5 females were dosed once with 50 mg/kg cyclophosphamide.
Examinations
- Tissues and cell types examined:
- Bone marrow from at least 1 femur of each animal used for smears. Cell types examined for the presence of micronuclei in Polychromatic (PCE) and normochromatic (NCE) erythrocytes.
- Details of tissue and slide preparation:
- Immediately following termination, bone marrow smears were prepared from sections of the femurs from each animal and stained with Giemsa. The incidence of micronucleated cells per 2000 polychromatic erythrocytes (PCE- bluish-gray cells) per animal was scored. Micronuclei are normally circular in shape, although occasionally they may be oval or half-moon shaped, and have a sharp contour with even staining. In addition, the number of normochromatic erythrocytes (NCE-pink-red stained cells) were counted; these cells were also scored for incidence of micronuclei. The ratio of polychromatic to normochromatic erythrocytes was calculated.
- Evaluation criteria:
- The criteria for determining a positive response included a dose-related statistically significant increase in micronucleated PCEs, or if no dose response was seen, a statistically significant increase in micronucleated PCEs for at least one level. A test article that induced neither a dose response nor a statistically significant increase for at least one dose level would be considered negative. The final decision was based on scientific judgement.
- Statistics:
- The data was analysed using Fischer's Exact Test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Abbott-87439 hydrochloride was considered non-clastogenic in this study.
Any other information on results incl. tables
Observations: Animals receiving 1200 mg/kg or more showed reduced activity and eyelids were partially closed shortly after dosing. Most mice recovered within a few hours. One female at 2400 mg/kg showed ataxia and one male at 1200 mg/kg were found dead 48 hours after dosing. For mice receiving the test substance there was no decrease in PCE/(PCE + NCE) indicating that there was no bone marrow toxicity, although there were signs of systemic toxicity. There were no statistically significant increases in the incidence of micronucleated polychromatic erythrocytes (PCEs). The frequency of micronucleated PCEs for the vehicle control group was within the historical control range. Positive controls showed a statistically significant increase in micronucleated PCEs and there were signs of bone marrow toxicity.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative non-clastogenic
Abbott-87439 was considered non-clastogenic in this study.
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