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Diss Factsheets
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EC number: 210-441-2 | CAS number: 615-66-7
- 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:
- genetic toxicity in vivo, other
- Remarks:
- Type of genotoxicity: Gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from SCCS report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- OPINION ON 2-Chloro-p-phenylenediamine COLIPA n° A8
- Author:
- European Cosmetics Toiletry and Perfumery Association (COLIPA)
- Year:
- 2 013
- Bibliographic source:
- Scientific Committee on Consumer Safety (SCCS), SCCS/1510/13, 19 September 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- In vivo Bone marrow micronucleus test for 2-chloro-p-phenylenediamine (1,4-diamino-2-chlorobenzene) was performed in rats.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2-chloro-p-phenylenediamine
- EC Number:
- 210-441-2
- EC Name:
- 2-chloro-p-phenylenediamine
- Cas Number:
- 615-66-7
- Molecular formula:
- C6H7ClN2
- IUPAC Name:
- 2-chlorobenzene-1,4-diamine
- Reference substance name:
- 1,4-diamino-2-chlorobenzene
- IUPAC Name:
- 1,4-diamino-2-chlorobenzene
- Details on test material:
- - Name of test material (as cited in study report): 1,4-diamino-2-chlorobenzene
- Molecular formula (if other than submission substance): C6-H7-Cl-N2
- Molecular weight (if other than submission substance): 142.588 g/mole
- Substance type: Organic
- Physical state: Solid
- Purity: 99%
- Impurities (identity and concentrations): 1 %
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 1,4-diamino-2-chlorobenzene
- Molecular formula: C6-H7-Cl-N2
- Molecular weight: 142.588 g/mole
- Substance type: Organic
- Physical state: Solid
- Purity: 99%
- Impurities (identity and concentrations): 1 %
Test animals
- Species:
- rat
- Strain:
- other: CFY SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- - Vehicle(s)/solvent(s) used: 0.5% gum tragacanth
- Justification for choice of solvent/vehicle: No data available
- Concentration of test material in vehicle: 0 and 900 mg/kg bw/day
- Amount of vehicle (if gavage or dermal): No data available
- Type and concentration of dispersant aid (if powder): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on exposure:
- No data available
- Duration of treatment / exposure:
- 30 hours
- Frequency of treatment:
- Twice in 24h interval
- Post exposure period:
- 6 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 and 900 mg/kg bw/day
Basis:
no data
- No. of animals per sex per dose:
- 5/sex/dose
Total: 20
0 mg/kg bw/day: 5 male, 5 female
900 mg/kg bw/day: 5 male, 5 female - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- No data available
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Test doses were based on the results of a preliminary toxicity study with doses between 800 and 900 mg/kg bw/day on a group of 5 male and 5 female rats recording clinical signs and mortality for a period of 30 h performed under identical conditions.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): No data available
DETAILS OF SLIDE PREPARATION: No data available
METHOD OF ANALYSIS: No data available
OTHER: No data available - Evaluation criteria:
- Increase in the number of bone marrow cells with micronuclei
- Statistics:
- No data available
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: between 800- 900 mg/kg bw/day
- Solubility: No data available
- Clinical signs of toxicity in test animals: Orange pigmented urine was observed.
- Evidence of cytotoxicity in tissue analyzed: No data available
- Rationale for exposure: No data available
- Harvest times: 30 hours
- High dose with and without activation: 900 mg/kg bw/day
- Other: No data available
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): No data available
- Induction of micronuclei (for Micronucleus assay): Biologically relevant increases in the number of polychromatic erythrocytes with micronuclei compared to the concurrent vehicle controls were not found in either males or females.
- 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:
- The substance 2-chloro-p-phenylenediamine (1,4-diamino-2-chlorobenzene) failed to induce an increase in the number of polychromatic erythrocytes with micronuclei in the bone marrow cells and hence is negative for gene mutation in vivo.
- Executive summary:
In a in -vivo gene toxicity test, CFY SPF male and female rats were treated with 2-chloro-p-phenylenediamine (1,4-diamino-2-chlorobenzene) in the concentration of 0 and 900 mg/kg bw/day. Bone marrow cells were collected 6 h after the last treatment. For each rat the percentage of polychromatic erythrocytes with a micronucleus was counted in 2000 polychromatic erythrocytes. Negative and positive controls were included.
2-chloro-p-phenylenediamine (1,4-diamino-2-chlorobenzene) failed to induce an increase in the number of polychromatic erythrocytes with micronuclei in the bone marrow cells and hence is negative for gene mutation in vivo.
According to the CLP classification, the test material does not classify as a gene mutant in vivo.
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