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EC number: 403-530-4 | CAS number: 129423-54-7 PV-ECHTGELB HGR
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Versálová žluť HGR (Pigment Yellow 191)
- IUPAC Name:
- Versálová žluť HGR (Pigment Yellow 191)
- Reference substance name:
- Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate
- EC Number:
- 403-530-4
- EC Name:
- Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate
- Cas Number:
- 129423-54-7
- Molecular formula:
- C17H15ClN4O7S2.Ca
- IUPAC Name:
- calcium 4-chloro-5-methyl-2-{2-[3-methyl-5-oxo-1-(3-sulfonatophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazen-1-yl}benzene-1-sulfonate
- Details on test material:
- Molecular formula: C17H15ClN4O7S2.Ca
Molecular weight: 524.9
Appearance: Yellow solid powder
Storage: the sample was stored in supplied container in dry room at the temperature > 30oC
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals: Albino laboratory rat, strain Wistar, healthy young adult males and females (nulliparous and non-pregnant)
Age at receiving: 6 – 7 weeks (at arrival)
Total number of animals: Pilot experiment: 9 animals (females), Main test: 100 animals (50 males and 50 females)
Random selection: According to SOP No.42
Acclimatisation: at least 5 days
Microclimatic conditions: Room temperature 22 + 3°C, permanently monitored
Relative humidity 30 – 70 %, permanently monitored
Light: 12 hours light/dark cycle: 6am-6pm/6pm-6am
Water: Drinking tap water ad libitum
Diet: Pelleted standard diet for experimental animals ad libitum
Bedding: Sterilized shavings of soft wood
Prophylactic arrangement: Cleaning and disinfection of animal room was regularly performed, as it is described in appropriate SOP No.10.
Administration / exposure
- Route of administration:
- oral: drinking water
- Duration of treatment / exposure:
- 24 and 48 hours for each dose level and each animal group
2000 mg/kg, exposition – 24 h: 5 males + 5 females
2000 mg/kg, exposition – 48 h: 5 males + 5 females
1000 mg/kg, exposition – 24 h: 5 males + 5 females
1000 mg/kg, exposition – 48 h: 5 males + 5 females
500 mg/kg, exposition – 24 h: 5 males + 5 females
500 mg/kg, exposition – 48 h: 5 males + 5 females - Frequency of treatment:
- Continuous exposure.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
500
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
1000
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
2000
Basis:
nominal in water
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- yes
Examinations
- Tissues and cell types examined:
- Bone marrow cells.
- Details of tissue and slide preparation:
- Bone marrow cells were obtained from the femora immediately after euthanasia of animals.
After excising and careful cleaning of the bone both femur ends were clipped off. Marrow
was gently flushed from the bone by 1 ml of bovine serum into the tube. Acquired bone
marrow was several times mixed by syringe with thin needle. The bone marrow with serum in tubes was centrifuged (5 min – 1000 rpm). The supernatant was gently removed, one drop of bovine serum was added to the sediment and this cell suspension was mixed on mixer.
Clean and degreased slides were marked by the number of study, number of animal, sex and
dose level. One drop of cell suspension was placed onto the slide and a smear was prepared
using a pusher slide. Two bone marrow smears were prepared per animal.
After drying (20 minutes, 60°C) the smears were fixed by ethanol – 5 minutes. Then they
were twice rinsed by distilled water and stained by 5% solution of Giemsa – 15 minutes.
Before examination, the slides were coded.
Stained smears were examined by light microscope. 200 erythrocytes were evaluated per
animal for the proportion of immature (polychromatic) and mature (normochromatic)
erythrocytes („cytotoxicity index“) in bone marrow.
At least 2000 polychromatic erythrocytes per animal were scored for the incidence of
micronucleated immature erythrocytes. - Evaluation criteria:
- The criteria for determining a positive result are dose-related increase in the number of
micronucleated cells or a clear increase in the number of micronucleated cells in a single dose
group at a single sampling time. Biological relevance of the results is considered first. - Statistics:
- The statistical analysis was performed by the ANOVA test - Analysis of Variance (software
QC.Expert 2.5, Trilobyte, Statistical Software, Czech Rep.).
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Clinical observation
No animal died during the main experiment.
No symptoms of toxicity were observed in all animals of all dose levels.
No symptoms of toxicity were observed in the animals of positive control group and
negative control groups.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test substance Versálová žluť HGR, was tested for the assessment of cytogenetic damage using micronucleus test.
Statistically significant increase in the count of micronucleated immature erythrocytes compared to the control was not recorded at any dose level.
Under the given test conditions, the test substance, Versálová žluť HGR, has negative result in micronucleus test.
Negative results in the micronucleus test indicate that under the test conditions the test
substance does not produce micronuclei in immature erythrocytes in bone marrow of rat.
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