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EC number: 220-168-0 | CAS number: 2650-18-2
- 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
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- The study is conducted on a read across test material. The complete read across justification is attached in section 13. The reliability of the original study is 2.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- 1000 instead of 2000 cells scored per animal
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Similar Substance 1
- IUPAC Name:
- Similar Substance 1
Constituent 1
- Specific details on test material used for the study:
- purity not specified
Test item name: Acid Blue 9
supplied by the Japan Food Additives Association, Tokyo
Test animals
- Species:
- mouse
- Strain:
- other: ddY
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuaka Agnicultural Cooperative Association for Laboratory Animals, Shizuoka
- Age at study initiation: Eight-weeks
- Diet ad libitum
- Water ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- physiological saline
- Duration of treatment / exposure:
- single injection
- Frequency of treatment:
- First experiment: one treatment
Second experiment: one treatment per day for four consecutive days - Post exposure period:
- 26h after single dosing
24h after last of the four doses
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Remarks:
- single treatment
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- single treatment
- Dose / conc.:
- 2 000 mg/kg bw/day (actual dose received)
- Remarks:
- single treatment
- Dose / conc.:
- 1 010 mg/kg bw/day (actual dose received)
- Remarks:
- four treatments in 24h intervals
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- MMC as positive control
physiological saline as vehicle control
Examinations
- Tissues and cell types examined:
- Femoral marrow cells
- Details of tissue and slide preparation:
- Femoral marrow cells were flushed out with foetal bovine serum and smeared on clean glass slides. Cells were fixed with methanol for 5 min, and stained with Acridine Orange for the pilot experimnent and with Giemsa for the main study.
1000 cells per animal were scored
The number of micronucleated polychromatic erythrocytes (MNPCE-s) was recorded.
The proportion of polychromnatic erthrocytes (PCEs) among the total erythrocytes was also evaluated by observing 1000 erythrocytes on the same slide. - Evaluation criteria:
- A positive response was defined as an increase in MNPCE which was statistically different from the control.
- Statistics:
- In the first step of the procedure, the frequencN of MNPCEs in each treatment group was compared with the binomial distribution specified by histonical control data from the laboratory (1 or 2) where the test was performed (Hayashi ei al. 1985). In the second step. the dose-response relationship was tested by the Cochran-Armitage trend test (Armitage, 1955, Cochran, 1954; Margolin & Risko, 1988).
Results and discussion
Test resultsopen allclose all
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Mortality at 2000 mg/kg bw
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: single dosing up to 2000 mg/kgbw
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- One animal died after the ip application of 2000 mg/kg bw.
Any other information on results incl. tables
4x 1010 mg/kg bw:
Micronucleated PCE: 0.18 +/0.15 % PCE 43.6 +/-13.8 % no mortality
2000 mg/kg bw
Micronucleated PCE: 0.34 +/- 0.15% PCE 51.4 +/-4.1 % 1/6 animals died
1000 mg/kg bw
Micronucleated PCE: 0.08 +/-0.08% PCE 49.0 +/- 4 % no mortality
500 mg/kg bw
Micronucleated PCE: 0.22 +/- 0.15% PCE 52.7 +/- 4% no mortality
vehicle control
Micronucleated PCE: 0.33 +/- 0.08% PCE 48.8 +/- 4.8% no mortality
Applicant's summary and conclusion
- Conclusions:
- Acid Blue 9 was not genotoxic in the micronucleus study in mice after intraperitoneal injection.
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