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EC number: 290-505-4 | CAS number: 90170-70-0
- 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: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The in vivo Pig-a assay uses flow cytometry to measure phenotypic variants for antibody binding to cell surface glycosylphosphatidylinositol (GPI)-anchored proteins. There is good evidence suggesting that the absence of antibody binding is the result of a mutation in the endogenous X-linked Pig-a gene, which forms the rationale for the assay.
The study was integrated into the OECD 422 guideline study described in section 7.8 and 7.5.
Gollapudi, B. B., Lynch, A. M., Heflich, R. H., et al. (2014). The in vivo Pig-a assay: A report of the International Workshop on Genotoxicity Testing (IWGT) Workgroup. Mutation Research: Genetic Toxicology and Environmental Mutagenesis, http://dx.doi.org/10.1016/j.mrgentox.2014.09.007 - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: in vivo pig A
Test material
- Reference substance name:
- Reaction mass of 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone and 9,10-Anthracenedione, 1,4-bis(pentylamino)-, branched and linear and 9,10-Anthracenedione, 1-(methylamino)-4-(pentylamino)-, branched and linear and 9,10-Anthracenedione, 1-[(2-ethylhexyl)amino]-4-(pentylamino)-, branched and linear
- EC Number:
- 911-360-1
- Molecular formula:
- variable structures
- IUPAC Name:
- Reaction mass of 1,4-bis(methylamino)anthraquinone and 1,4-bis[(2-ethylhexyl)amino]anthraquinone and 1-[(2-ethylhexyl)amino]-4-(methylamino)anthraquinone and 9,10-Anthracenedione, 1,4-bis(pentylamino)-, branched and linear and 9,10-Anthracenedione, 1-(methylamino)-4-(pentylamino)-, branched and linear and 9,10-Anthracenedione, 1-[(2-ethylhexyl)amino]-4-(pentylamino)-, branched and linear
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Corn Oil
- Duration of treatment / exposure:
- dosed daily for 14 days prior to mating and continuing throughout the mating period for at least 34 days
- Frequency of treatment:
- once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 6 male animals were included into the OECD 422 study as a satellite group, serving as the positive control for the pig A portion of the study. These animals were exposed to N-Ehtyl-N-nitroso-urea (759-73-9) on test days 1-3 of the study at a dose level of 20 mg/kg bw/day via gavage in an acidic buffer solution (KH2PO4, Na2HPO4).
Examinations
- Tissues and cell types examined:
- red blood cells
- Statistics:
- The Pig-a assay data were analyzed by the following statistical methods as recommended in Gollapudi et al. (2014). A Bartlett’s test (alpha=0.01; Winer, 1971) was used to test for homogeneity of variance, the test was also sensitive to normality. Transformations of mutant frequencies (e.g., a log (10) transformation) were conducted to meet these assumptions when necessary. Since zeroes may have been observed occasionally, prior to the log-transformation, an offset of +0.1 (i.e., addition of 0.1 to each mutant cell frequency expressed as mutants × 10−6) may have been required. An analysis of variance (ANOVA) followed by pair-wise comparisons of mutant frequencies in treated groups to the vehicle control group was performed utilizing a one-sided (upper to detect an increase in mutant cells) Dunnett’s test at alpha=0.05 for mutant RBC and mutant RET and a 2-sided Dunnett’s test at alpha=0.05 for percent RET. If any of the pairwise tests were significant, evidence of dose-related increases were evaluated with a linear trend test. The positive control was compared to the vehicle control with an analysis of variance followed by a one-sided (upper) Dunnett’s test at alpha=0.05 for mutant RBC and mutant RET and a 2-sided Dunnett’s test at alpha=0.05 for percent RET.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- general toxixity - increased liver weights, and histopathology in the pancreas - effects decribed in Repeat dose tox section
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Two animals with pre-exposure frequency of CD59-negative
reticulocytes (RETCD59-) exceeding the reported background
range of 0-5 × 10-6(Gollapudiet al.,2014),
(animal 2458 in the 300 mkd test material group and animal 2472 in the
1000 mg/kg/day test material group) were excluded from the post-exposurePig-aassay. Six
male animals from eachC.I. Solvent Blue 98 (3Amine)treated group and the
vehicle control group were selected for the post-exposurePig-aassay
by the ascending order of animal ID among surviving animals with
pre-exposure frequency of RETCD59-not exceeding
5 × 10-6.
The frequencies(×10-6)of RETCD59-and RBCCD59-in the vehicle control animals were within the reported background range (Gollapudiet al.,2014). The frequencies of RETCD59-and RBCCD59-in the positive control (ENU) group were significantly higher than those in the vehicle control group (Text Table 12). The normal frequencies of RETCD59-and RBCCD59-in the vehicle control animals and the significantly increased frequencies of RETCD59-and RBCCD59-in the positive control animals indicated acceptability of the test system for identifying a mutagen. There were no significant differences in the frequency of RETCD59-or RBCCD59-among the vehicle control group and theC.I. Solvent Blue 98 (3Amine)treated groups (Text Table 12).
There were no significant differences in the percentage of reticulocytes (% RET) among the vehicle control group and theC.I. Solvent Blue 98 (3Amine)treated groups (Text Table 12); however, the gross pathology observation of blue discoloration of tissue observed at necropsy demonstrated that theC.I. Solvent Blue 98 (3Amine)and/or its metabolites were absorbed and systemically bioavailable after oral gavage (see adult gross pathology) .
Therefore,C.I. Solvent Blue 98 (3Amine)was negative in thisin vivogene mutationPig-aassay under the experimental conditions used.
Applicant's summary and conclusion
- Conclusions:
- C.I. Solvent Blue 98 (3Amine) was negative in this in vivo gene mutation Pig-a assay under the experimental conditions used.
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