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EC number: 401-270-6 | CAS number: 122390-99-2
- 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: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-Sep-16 to 1985-Oct-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- No major deviations
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Reactive Blue FC 15353
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen
- Age at study initiation: 8-12 weeks
- Weight at study initiation:25-37 g
- Assigned to test groups randomly: yes, under following basis: according to a plan from the Institute for Biometry, Bayer AG, Wuppertal
- Housing: 3 or 5 animals (males/females separated) per macrolon cage (type I or III) on wood granulate
- Diet (e.g. ad libitum): Altromin 1324, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22 °C
- Humidity (%): 60-90 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- test substance: 0.5 % aqueous Cremophor-emulsion
positive control: deionized water
negative control: 0.5 % aqueous Cremophor-emulsion - Details on exposure:
- volume of oral application:
test substance and negative control: 20 ml/kg body weight
positive control: 10 ml/kg body weight - Duration of treatment / exposure:
- test substance: 24, 48 and 72 hours
positive and negative control: 24 hours - Frequency of treatment:
- single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
7500 mg/kg body weight
Basis:
no data
- No. of animals per sex per dose:
- 5/sex
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): well-known cytostatic drug and clastogene with bifunctional alcylating effect
- Route of administration: oral, gavage
- Doses / concentrations: 20 mg/kg body weight
Examinations
- Tissues and cell types examined:
- bone marrow of femur
1000 polychromatic erythrocytes counted per animal plus number of mature eryhtrocytes per 1000 polychromatic erythrocytes - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Based of a pretest with 5000 mg/kg body weight and 7500 mg/kg body weight (5 animals each); test substance application: gavage; single dose.
Both doses caused clinical symptoms within 72 hours, i.e. somnolescence, blue discoloration of skin and feces, pale eyes and bristled fur. No death occured.
DETAILS OF SLIDE PREPARATION:
erythrocytes were prepared according to the method reported by W. Schmid, Mutation Res. 31, 9-15, 1975
samples were stained using a slide stainer Typ Haematek, Fa. Miles and than wahsed with methanol and water, and subsequently dried
prior to analysis, samples were covered by glass after 10 min incubation in xylene
METHOD OF ANALYSIS:
1000 polychromatic erythrocytes and mature eryhtrocytes per 1000 polycrhomatic erythrocates were counted using a light microscop with 1000x magnification. - Evaluation criteria:
- The test substance is considered positive if the mean number of micronucleated polychromatic erythocytes of the test substance group is higher than in the negativ control group; and, if so, the significance level calculated by the Wilcoxon signed-rank test is < 5 %.
- Statistics:
- Numbers of micronucleated polychromated erythrocytes per 1000 polychromated erythrocytes were counted from 5 animals/sex for each exposure time plus negative and positive control and means were calculated. A Wilcoxon signed-rank test was performed when the mean of the test substance was higer than the negative control.
Additional the 1s-intervals were calculated.
The usage of the Wilcoxon signed-rank test is appropiate; the significance level of < 5 % is appropiate.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- somnolescence, blue discoloration of skin and feces, pale eyes and blistered fur
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- the test item had no effect on erythopesis.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Reactive Blue FC 15353 did not cause an increase of micronucleated polychromatic erythrocytes and is therefore considered not-clastogenic in the micronucleus in vivo test. - Executive summary:
In a NMRI mouse bone marrow micronucleus assay, (5/sex) were treated once by gavage with Reactive Blue FC 15353 at a dose of 7500 mg/kg bw. Bone marrow cells were harvested at 24, 48, and 72 hours post-treatment. The vehicle was 0.5 % aqueous cremophor-emulsion.
There were signs of toxicity (somnolescence, blue discoloration of skin and feces, pale eyes and blistered fur) during the study. Reactive Blue FC 15353 was tested at an adequate dose based on pretests with 5000 mg/kg bw and 7500 mg/kg bw. The positive control induced the appropriate response. There was not a significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after any treatment time.
This study is classified as acceptable. It satisfies the requirement for Test Guideline OECD 474 for in vivo cytogenetic mutagenicity data.
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