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EC number: 202-544-6 | CAS number: 96-91-3
- 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 somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- OPINION ON Picramic acid and sodium picramate COLIPA n° B28
- Author:
- Scientific Committee on Consumer Safety
- Year:
- 2 012
- Bibliographic source:
- Scientific Committee on Consumer Safety, (SCCS) 18 September 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2 Amino -4,6 Dinitrophenol
- IUPAC Name:
- 2 Amino -4,6 Dinitrophenol
- Reference substance name:
- 2-amino-4,6-dinitrophenol
- EC Number:
- 202-544-6
- EC Name:
- 2-amino-4,6-dinitrophenol
- Cas Number:
- 96-91-3
- Molecular formula:
- C6H5N3O5
- IUPAC Name:
- 2-amino-4,6-dinitrophenol
- Test material form:
- other: Dark red needles
- Details on test material:
- - Name of test material (as cited in study report):2 Amino -4,6 Dinitrophenol
- Molecular formula (if other than submission substance): C6H5N3O5
- Molecular weight (if other than submission substance): 199.125g\mol
- Substance type: Organic
- Physical state: Dark red needles.
- Purity : > 99%
- Impurities (identity and concentrations): No data available.
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- other: Crl:NMRI BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- 2% Carboxymethylcellulose
- Duration of treatment / exposure:
- 24 hour for Test group
48 hour for negative control group - Frequency of treatment:
- Single dose
- Post exposure period:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50 mg/kg bw
Basis:
no data
- No. of animals per sex per dose:
- 0 mg/kgbw-5 male and 5 female (Negative control group)
50 mg /kg bw -5 male and 5 female (Treated group)
40 mg/kg bw-5 male and 5 female (positive control group) - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Positive control group was treated with cyclophosphamide at a dose of 40 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Based on data from data of a preliminary toxicity assay the test article was administered
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
DETAILS OF SLIDE PREPARATION: No data available.
METHOD OF ANALYSIS: No data available.
OTHER: No data available - Evaluation criteria:
- Increase in the number of polychromatic erythrocytes with micronucleus indicates that the substance was mutagenic
- Statistics:
- No data available
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
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay):
- Induction of micronuclei (for Micronucleus assay): No, the test substance did not induce any significant increase in the frequency of micronuclei in the spolychromatic erythrocytes.
- Ratio of PCE/NCE (for Micronucleus assay): No data available.
- Appropriateness of dose levels and route: No data available.
- Statistical evaluation: No data available.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Picramic acid did not induce an increase in the number of polychromatic erythrocytes with micronuclei in treated mice and, consequently, was not genotoxic in bone marrow cells of mice. The result was found to be negative. - Executive summary:
In vivo genotoxicity study for Picramic acid in male and female Crl: NMRIBR mice by In vivo Mammalian Erythrocytes Micronucleus Test were found to be negative.
An increase in the number of normochromatic erythrocytes and decrease in the number of polychromatic erythrocytes respectively could not be observed in the treated groups. This indicates that Picramic acid exerted no toxic influence in the bone marrow. A single oral administration of picramic acid at a dose of 50 mg/kg bw to male and female mice did not produce a significant increase in the frequency of micronuclei in the polychromatic erythrocytes.
According to historical data from NMRI mice, the mean values of all parameters measured were within the respective normal range. The positive control group, treated with cyclophosphamide, revealed a significant increase in the number of micronucleated polychromatic erythrocytes. Picramic acid did not induce an increase in the number of polychromatic erythrocytes with micronuclei in treated mice and, consequently, was not mutagenic in bone marrow cells of mice.
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