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EC number: 274-950-1 | CAS number: 70865-20-2
- 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 germ cell study: gene mutation
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19th May to 2nd July 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Salamone, Heddle and Katz (1981) Mutagenic activity of 41 compounds in the in vitro micronucleus assay. Prog.Mut.Res.Vol 1, p.686-697.
- Deviations:
- no
- Principles of method if other than guideline:
- The test is based on the following principles:
-After chromosomal damage has been induced by test compound or its metabolites, acentric fragments of chromosomal material lag behind at anaphase. After telophase a large portion of the fragments is not included in the main nucleus of the cell, hence micronuclei are formed.
Micronuclei can be formed in a wide variety of cell types, but in this test system erythrocytes are observed because micronuclei can easily be detected in this cell type since the nucleus proper is extruded during maturation. - GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Sodium 4-[[4-[(4-hydroxy-2-methylphenyl)azo]phenyl]amino]-3-nitrobenzenesulphonate
- EC Number:
- 274-950-1
- EC Name:
- Sodium 4-[[4-[(4-hydroxy-2-methylphenyl)azo]phenyl]amino]-3-nitrobenzenesulphonate
- Cas Number:
- 70865-20-2
- Molecular formula:
- C19H16N4O6S.Na
- IUPAC Name:
- sodium 4-[[4-[(4-hydroxy-2-methylphenyl)azo]phenyl]amino]-3-nitrobenzenesulphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Acid Yellow 199
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: C57BL/6J
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Unit, Alderley Park, Macclesfield, Cheshire
- Age at study initiation: 6-8 weeks
- Assigned to test groups randomly: [no/yes, under following basis: ]
- Fasting period before study:
- Housing: 5 per cage
- Diet (ad libitum): Porton Combined Diet [PCD] supplied by BP Nutrition Ltd, Stepfield, Witham, Essex, UK
- Water (ad libitum): tap water
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 39-76
- Air changes (per hr): 22
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 19th May to 2nd July 1982
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: Kraft Wesson Corn Oil (Kraft Foods Ltd, Liverpool, UK)
- Justification for choice of solvent/vehicle: limited solubility in water - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The est substance was suspended in corn oil
- Duration of treatment / exposure:
- 72 hours
- Frequency of treatment:
- Animals were dosed with 2 consecutive Intraperitoneal Injections, administered 24 hours apart
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 625 mg/kg bw/day
- No. of animals per sex per dose:
- 15 males and 15 females per dose group
5 animals/sex each were sacrificed 24, 48, 72 hours after the last treatment - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Justification for choice of positive control(s): according to the used method
- Route of administration: intraperitoneal
- Doses / concentrations: 75 mg/kg
Examinations
- Tissues and cell types examined:
- 500 mg polychromatic erythrocytes were examined and the number containing micronuclei scored. The sample was also examined for any evidence of cytotoxicity.
- Details of tissue and slide preparation:
- The animals were killed by cervical dislocation after the last dose of compound.
Femurs were removed and stripped clean of muscle.
The iliac end of the femur was removed and a fine paint brush wetted with a solution of albumen (6% v/v in saline) was dipped into marrow canal.
3 to 4 streaks of marrow suspension were then applied to appropriately labelled clean, dry microscope slides.
The slides were allowed to air dry.
The slides were then stained in Wright's stain using an Ames Hema-Tek staining machine (Hema-Tek, Miles Laboratory Limited, Stoke Court, Stoke Poges, Slough, UK)
Slides were coded and scored blind. - Evaluation criteria:
- One of the evaluation criteria is that, the test is considered positive if: The test item induces any statically significant increase in the frequency of the micronuclei when compare to the control animals.
- Statistics:
- The results were analysed for significant differences from the control using a one slide Student's "t" test.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Acid Yellow 199 gave negative results at all three sampling times, even though there were a number of deaths which occurred in the higher dose level animals. These deaths were unexpected based on the LD50/7T, data and were probably due to administration of the compound as a split dose rather than a single treatment. However, the 625mg/kg dose group would qualify as a maximum tolerated dose at the 48 and 72hr sampling times.
Applicant's summary and conclusion
- Conclusions:
- The results indicate that Acid Yellow 199 has no clastogenic activity in the mouse micronucleus test.
- Executive summary:
Acid Yellow 199 was tested for clastogenic activity in the mouse micronucleus test using C57BL/6J mice. The test item did not induce any statistically significant increase in the frequency of the micronuclei when compared to control animals. Throughout the study the positive control substance, cyclophosphamide gave the expected responses. The results indicate that Acid Yellow 199 has no clastogenic activity in the mouse micronucleus test.
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