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EC number: 240-385-4 | CAS number: 16294-75-0
- 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: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 1994
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Purity is out of range, Insufficient analytic data
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 14H-anthra[2,1,9-mna]thioxanthen-14-one
- EC Number:
- 240-385-4
- EC Name:
- 14H-anthra[2,1,9-mna]thioxanthen-14-one
- Cas Number:
- 16294-75-0
- Molecular formula:
- C23H12OS
- IUPAC Name:
- 8-thiahexacyclo[10.10.2.0²,⁷.0⁹,²³.0¹³,¹⁸.0²⁰,²⁴]tetracosa-1(23),2,4,6,9,11,13,15,17,20(24),21-undecaen-19-one
- Reference substance name:
- 95,5%
- IUPAC Name:
- 95,5%
- Test material form:
- not specified
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Moellegaard Breeding Centre Deutschland GmbH, HauptstraBe 62, 16352 Schönwalde
- Age at study initiation: 8 weeks
- Weight at study initiation: m: 31-48 g; f: 26 - 34 g
- Assigned to test groups randomly: yes
- Fasting period before study: no data
- Housing: groups of 5 per sex
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum):ad lib.
- Acclimation period: >6 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%):50-90
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Aqueous starch mucilage
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: single administration
- Duration of treatment / exposure:
- 12, 24 or 48 hours
- Frequency of treatment:
- single
- Post exposure period:
- 12, 24 or 48 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2000 mg/kg (Limit dose)
Basis:
actual ingested
(gavage)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide;
- Justification for choice of positive control(s):
- Route of administration: oral
- Doses / concentrations: 0,5 % (w/v)
Examinations
- Tissues and cell types examined:
- Bone marrow from femur
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Limit dose based on "no toxicity"
DETAILS OF SLIDE PREPARATION:
Extraction of the bone marrow
In conformity with the test procedure the animals were killed by carbon dioxide asphyxiation 12, 24 or 48 hours after application. For each animal, about 3 ml foetal bovine serum was poured into a centrifuge tube.
Both femora were removed and the bones freed of muscle tissue. The proximal ends of the femora were opened and the bone marrow flushed into the centrifuge tUbe. A suspension was formed. The mixture was then centrifuged for 5 minutes at approx. 1200 rpm, after which almost all the supematant was discarded. One drop of the thoroughly mixed sediment was smeared onto a cleaned slide, identified by project code and animal number and air-dried for about 12 hours.
Staining procedure
- 5 minutes in methanol
- 5 minutes in May-GrOnwalds solution
- brief rinsing twice in distilled water
- 10 minutes staining in 1 part Giemsa solution 10 6 parts buffer solution, pH 7.2 (Weise)
- rinsing in distilled water
- drying
- coating with Entellan
METHOD OF ANALYSIS: Manual countig of cells with micronuclei in 1000 polychromatic erythrocytes per slide. A Wilcoxon-Test (one-sided) was evaluated to check the validity of the study. This is done by comparing the number of polychromatic erythrocytes with micronuclei in the positive control with the negative control.
A Wilcoxon-Test (one-sided) was performed for each measurement group (12h, 24h, 48h) and for polychromatic and normochromatic erythrocytes. These tests are performed sequentially with a munlple level of significance of 5% - Evaluation criteria:
- Both biQlogical and statistical significances were considered together fQr evaluatiQn purposes.
A substance is considered as positive if there is a significant increase in the number Qf micronucleated polychromatic erythrocytes fQr at least Qne Qf the time points. A test substance producing nQ significant increase in the number Qf micronucleated polychromatic erythrocytes is considered nQn-mutagenic in this system. - Statistics:
- comparing
the number of polychromatic erythrocytes with micronuclei in the positive control with the negative
control.
A Wilcoxon-Test (one-sided) [6,7) was performed for each measurement group (12h, 24h, 48h) and for
polychromatic and normochromatic erythrocytes. These tests are performed sequentially with a munlple
level of significance of 5% (5).
The following comparisons are performed only if there is a difference between the positive conlrol and the
negative control (24h). This Is tested with a Wilcoxon-Test (two-sided) [6,7) with a 5 %-Ievel of significance.
Wilcoxon-Tests (two-sided) are performed sequenlially for the ratio of polychromatic erythrocytes for each
measurement group (12h, 24h, 48h) al a muniple level of significance of 5 % (5). Actual data were also
compared with historical controls.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- positive
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
Fluorescent Red YJGG lead tQ a substantial increase of micronucleated polychromatic erythrocytes and is mutagenic in the micronucleus test. - Executive summary:
Fluorescent Red YJGG was tested in the micronucleus test. The test compound was suspended in starch mucilage and dosed once orally at 2000 mg per kg body weight to male and female mice, based on the results of a previous dose range finding assay (see preiiminary study). According to the test procedure the animals were killed 12, 24 or 48 hours after administration.
Endoxan* was used as positive control substance and was administered once orally at a dose of 50 mg per kg body weight.
The number of polychromatic erythrocytes containing micronuclei was statistically significant increased at the 24 hours killing time in male and female mice. The ratio of polychromaticlnormochromatic erythrocytes in both male and female animals remained unaffected by the treatment with Fluorescent Red YJGG and was statistically not different from the control values.
Endoxan* induced in both males and females a , .arked statistically significant increase in the number of polychromatic cells with micronuclei, indicating the sensitivity of the test system. The ratio of polychromatic erythrocytes to normocytes was not changed to a significant extent.
Under the conditions of the present study the results indicate that Fluorescent Red YJGG is mutagenic in the micronucleus test.
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