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EC number: 403-830-5 | CAS number: 89331-94-2 B 290; BK 400; CK 34; DIBUTYL-N-102; DX-20; FAT NR. 40391/A; FLUORAN BLACK BD 869; FLUORAN SCHWARZ BD 869; NOIR FLUORANE BD 869; ODB-2; PSD-290; SENOR-2; TG-31; TH-108; WINCON-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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
None of the studies undertaken, Ames, Chromosome Aberrations and Mouse Lymphoma Assay demonstrated that ODB-2 exhibits genetic toxicity.
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 June to 28 July 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Chinese hamster ovary (CHO) cells, strain K1-BH4
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 4, 20 and 40 µg / ml
- Vehicle / solvent:
- - Solvent used: DMSO;
- Justification for choice of solvent: commonly used as a vehicle. - Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension;
DURATION
- Preincubation period: 24 hours
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 17 hours
- Selection time (if incubation with a selection agent): 21 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 49 hours
SPINDLE INHIBITOR (cytogenetic assays): Colchicine
NUMBER OF REPLICATIONS: 1
NUMBER OF CELLS EVALUATED: no data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index;
OTHER EXAMINATIONS:
Chromosome aberrations
Gaps / Breaks; Chromatid and isochromatid
Chromatid exchanges
Dicentric chromosomes
Acentric chromosome fragments
Chromosome rings
Complex rearrangements. - Evaluation criteria:
- Chromosomes are examined in these metaphase cells for the presence of the following aberrations:
Gaps, breaks, Chromatid and isochromatid
Chromatid exchanges
Dicentric chromosomes
Acentric chromosome fragments
Chromosome rings
Complex rearrangements.
A gap is defined as an achromatic region (occurring in one or both chromatids) which is smaller than the width of a single chromatid. The
separated regions are still aligned. A break is defined as an achromatic region, occurring in one or both chromatids, that is greater than the width of a single chromatid. The accompanying fragment is usually displaced from the rest of the chromosome. - Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Preliminary Toxicity Test
A 50 ml culture of CHO cells was harvested as follows: The supernatant medium was removed and the cells washed in 0.9% sterile
saline; 20 ml of 0.25% trypsin was then added for 30 seconds. The trypsin solution was removed and the flask incubated at 37°C for 10 minutes. The cells were then resuspended in 20 ml Hams F12 + 5% FCS and diluted to give 8E+04 cells/mI. Aliquots (5 ml) of cells were added to Nunc 25 cm2 tissue culture flasks and the cultures incubated at 37°C in a humid atmosphere containing 5% carbon dioxide.
After approximately 24 hours 1.25 µl of S-9 mix was added to one set of cultures followed by 62.5 µl of various dilutions of the test compound and of the solvent. To the second set of cultures (i.e. without S-9 mix) 50 µl of the dilutions of test compound and of the solvent were added. Final concentrations of test compound in both sets were 0.6, 1.3, 2.5, 5, 10, 20 and 40 µg/ml with single flasks for each concentration and duplicate flasks for the solvent control. The cultures without S-9 mix were incubated in the presence of the test compound for 21 hours.
Four hours after the addition of the test compound to those cultures treated with S-9 mix, the medium containing the S-9 mix and test
compound was carefully removed and replaced with fresh Hams F12 + 5% FCS. The cultures were returned to the incubator for a further 17 hours.
Metaphase analysis
After approximately 24 hours incubation 1.25 ml of S-9 mix was added to one set of cultures followed by 62.5 µl a1iquots of various dilutions of the test compound giving final concentrations of 4, 20 and 40 µg/ml. Two cultures were treated at each dose level. Four cultures were treated with 62.5 µl aliquots of the solvent control, DMS0, and two with 62.5 µl aliquots of the positive control compound, cyclophosphamide, at a final concentration of 20 µg/ml. The cultures were then incubated at 37°C. To the remaining set of cultures (i.e. without S-9 mix) 50 µl aliquots of the test compound were added giving final concentrations of 4, 20 and 40 µg/ml. 50 µl aliquots of the solvent were added to four cultures, and 50 µl aliquots mitomycin C, which was used as the positive control at a final concentration of 0.4 µg/ml, were added to two cultures. The cultures were then incubated at 37°C. Four hours after addition of test compound those cultures treated with S-9 mix had the medium carefully removed and replaced with fresh Hams F12 + 5% FC5. The cultures were then returned to the incubator for a further 17 hours.
All cultures were treated with colchicine, harvested, fixed and slides prepared as described in section {e}. The slides were stained in 10% Giemsa, mounted in DPX and coded. Metaphase spreads were identified using a magnification of x160 and examined at a magnification of x1000 using an oil immersion objective. Approximately 100 metaphase figures were examined where possible from each culture, with normally a maximum of 25 from each slide. - Remarks on result:
- other: strain/cell type: K1-BH4
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
It is concluded that ODB-2 has shown no evidence of clastogenic activity in this in vitro cytogenetic test system. - Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 to 28 February 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- Dose range finding test; 5000, 500, 50 and 5 µg / plate
Mutation tests; 5000, 1500, 500, 150 and 50 µg / plate - Vehicle / solvent:
- - solvent: DMSO
- Justification for choice of solvent: Commonly used in this study. - Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:in agar (plate incorporation)
DURATION
- Preincubation period: 10 hours
- Exposure duration: 72 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 82 hours
NUMBER OF REPLICATIONS: 1
NUMBER OF CELLS EVALUATED: 2E+09 - Evaluation criteria:
- The mean number of revertant colonies for all treatment groups is compared with those obtained for negative and positive control groups. The effect of metabolic activation is assessed by comparing the results obtained both in the presence and absence of the liver
microsomal fraction for each treatment group.
A compound is deemed to provide evidence of mutagenic potential if a statistically significant dose-related increase in the number of revertant colonies of at least twice the concurrent solvent control is obtained in two separate experiments. - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: The revertant colony counts for ODB-2 obtained in the dose range finding test are show ODB-2 was not toxic towards the tester strains. Therefore 5000 µg/plate was chosen as the top dose level in the mutation tests.
- Conclusions:
- Interpretation of results (migrated information):
negative
It is concluded that no evidence of mutagenic potential of ODB-2 was obtained in this bacterial test system at the dose levels used. - Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 January to 06 March 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- Thymidine kinase locus.
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 1.0, 2.5, 5.0, 10.0, 15.0, 30.0 and 50.0 µg / ml
- Vehicle / solvent:
- - solvent used: DMSO;
- Justification for choice of solvent: commonly used and accepted. - Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Used in the absence of S-9 mix
- Positive controls:
- yes
- Positive control substance:
- other: 20-methylcholanthrene
- Remarks:
- Used in presence of S-9 mix.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: as a solution
DURATION
- Preincubation period: 3 hours @ 37°C
- Exposure duration:
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):
NUMBER OF REPLICATIONS: 1
NUMBER OF CELLS EVALUATED: 600
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:
OTHER: - Evaluation criteria:
- The criteria which must be satisfied before a positive response may be claimed are:
1. The induction of at least a two-fold increase in mutant frequency relative to the concurrent control by the test agent.
2. The demonstration of a statistically significant response.
3. Evidence of a dose-related response.
4. The response must be reproducible.
5. The data are acceptable according to the criteria detailed in Arlett et ai. (1989), in 'Statistical Evaluation of Mutagenicity Test Data', pp. 66 - 101, Cambridge University Press. - Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Preliminary toxicity test
A suspension of cells was prepared in a 50 : 50 mixture of conditioned medium (obtained by the removal of cells from an exponentially growing culture by centrifugation) and R5 at a cell population density of 1E+06/ ml. This culture was rolled at 37°C whilst the compound dilutions and S-9 mix were prepared.
3 ml aliquots of cell suspension were dispensed into universal containers, followed by 2 ml RO or S-9 mix. 50 µl of compound solution or DMSO in the case of the controls were then added. Two cultures per dose level were prepared, one with and one without S-9 mix.
The universal containers were placed on the roller apparatus at 37°C for 3 hours. After incubation, the cells were washed once with serum-free medium, the 20 ml contents of each universal container transferred to a pre-gassed (5% CO2 : 95% air) Corning roller bottle containing 10 ml growth medium, and placed on the roller apparatus. Cell population growth was monitored at 24 and 48 hours after treatment by counting the cells using a Coulter electronic particle counter, Model ZM. After 24 hours the cell suspensions were diluted with R10p to restore the cell population density to 2 x 105 cells/ml.
SUMMARY
ODB-2 was tested for mutagenic potential in an in vitro manunalian cell mutation assay. This test system is based on detection and quantitation of forward mutation in a subline of mouse lymphoma L5178Y cells, from the heterozygous condition at the thymidine kinase locus (TK+ I) to the thymidine kinase deficient genotype (TK/.). Two independent tests in the absence of exogenous metabolic activation and two independent tests in the presence of S-9 mix were carried out.
Cytotoxicity was observed after treatment with ODB-2 in all the tests in the absence and the presence of S-9 mix.
Treatment with ODB-2 induced statistically significant increases in mutant frequency in both tests in the absence of S-9 mix. In test 2 these increases were dose-related. Statistically significant increases were also observed in test 1 in the presence of S-9 mix. However, the criteria for a positive response were not fully satisfied.
It is concluded that the evidence regarding the mutagenic potential of ODB-2 is equivocal in the absence of S-9 mix. On the balance of evidence no mutagenic potential exists in the presence of S-9 mix. - Remarks on result:
- other: strain/cell type: Mouse lymphoma L5178Y cells
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
It is concluded that the evidence regarding the mutagenic potential of ODB-2 is equivocal in the absence of S-9 mix. On the balance of evidence no mutagenic potential exists in the presence of S-9 mix.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
From the results obtained in an in vitro mouse micronucleus test it is concluded that ODB-2 shows no evidence of mutagenic potential or bone marrow cell toxicity.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 February to 18 March 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study undertaken at GLP accredited laboratory to internationally accepted guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1982
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1984
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay)
- Version / remarks:
- 1987
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
- Species:
- mouse
- Strain:
- CD-1
- Details on species / strain selection:
- Specific Pathogen Free CD-1 outbred mice of Swiss origin
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: reputable laboratory animal supplier
- Age at study initiation: approximately 39 days
- Weight at study initiation: 22 to 24 grams
- Assigned to test groups randomly: yes
- Fasting period before study: overnight and 2hrs after dosing
- Housing: groups of 2 or 5 mice
- Diet: standard pelleted rodent diet (ad libitum)
- Water: tap water (ad libitum)
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): not reported
- Air changes (per hr): 30
- Photoperiod (hrs dark / hrs light): 12l ight/12 dark
IN-LIFE DATES: From:12 February to 18 March 1991 - Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: methyl cellulose
- Justification for choice of solvent/vehicle: inert suspending agent. - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Suspensions of ODB-2 were prepared in aqueous 1% methylcellulose on the morning of the test at 250 mg/ml. - Duration of treatment / exposure:
- single oral dose
- Frequency of treatment:
- not applicable
- Post exposure period:
- 24, 48 or 72 hours
- Dose / conc.:
- 5 000 mg/kg bw/day (actual dose received)
- Remarks:
- maximum dose recommended dose by the US EPA and the Joint Directive of the JEPA/MOHW/MITI.
- No. of animals per sex per dose:
- 15 male and 15 female
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- mitomycin C;
- Justification for choice of positive control(s):
- Route of administration: oral gavage
- Doses / concentrations: solution in sterile 0.9% saline at a concentration of 0.6 mg/ml. - Tissues and cell types examined:
- Bone marrow/erythrocytes
- Details of tissue and slide preparation:
- STAIN (for cytogenetic assays): 10% Giesma
A direct bone marrow smear was made onto a slide containing a drop of calf serum. - Evaluation criteria:
- A positive response is normally indicated by a substantial, dose-related and statistically significant increase in the incidence of micronucleated polychromatic erythrocytes compared to the incidence for the concurrent vehicle control group. In borderline cases, e.g. where the response is not dose-related or where individual group mean values do not fall outside our historical control range, further testing may be necessary.
Bone marrow cell toxicity (or depression) is normally indicated by a substantial, dose-related and statistically significant decrease in ·the ratio of polychromatic to normochromatic erythrocytes. This decrease would normally be evident at both the 48 and 72 hour sampling points, a decrease at the 24 hour time point is not necessarily expected because of the relatively long transition time of erythroid cells [late normoblast » polychromatic erythrocyte (approximately 6 hours) » normochromatic erythrocyte (approximately 30 hours)]. - Statistics:
- Kill Compound Dosage Ratio Incidence Incidence
(mg/kg) p/n mnp mnn
Mean P Mean P Total
0/00 0/00
24 Vehicle - 1.187 - 0.1 - 0.2
hour control
ODB-2 5000 1.270 0.485 0.5 0.072 0.2
Mitomycin C 12 0.561 <0.001 29.7 <0.001 0.9
48 Vehicle - 1.220 - 0.1 - 0.4
hour control
ODB-2 5000 1.071 0.218 0.2 0.370 0.4
- 1.368 - 0.6 - 0.2
72 Vehicle
hour control
ODB-2 5000 1.318 0.685 0.8 0.241 0.4
P Probability value (I-sided) obtained using Wilcoxon's sum of ranks test (6)
p/n Ratio of polychromatic to normochromatic erythrocytes
mnp Number of micronucleated polychromatic erythrocytesobserved
mnn Number of micronucleated normochromatic erythrocytes observed
0/00 Number per thousand cells - Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- Minor signs of toxicity only (pilo-erection, hunched posture, lethargy, ptosis)
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Preliminary toxicity test
No mortalities were obtained in the preliminary toxicity test. As only minor signs of toxicity were obtained during the preliminary toxicity test, a dosage of 5000 mg ODB-2 per kg bodyweight was chosen for the micronucleus test.
Micronucleus test
(a) Signs and mortalities
No mortalities were obtained in the micronucleus test. Clinical signs for animals treated with ODB-2 were pilo-erection, hunched posture, lethargy and ptsosis. No adverse clinical signs were obtained for the vehicle control or positive control treated animals over the duration of the test.
(b) Micronucleated polychromatic erythrocyte counts (mnp)
ODB-2 did not cause any statistically significant increases in the number of micronucleated polychromatic erythrocytes.
Mitomycin C caused large, highly significant increases in the frequency of micronucleated polychromatic erythrocytes.
(c) Micronucleated normochromatic erythrocytes ( mnn)
ODB-2 did not cause any substantial increases in the incidence of micronucleated normochromatic erythrocytes.
(d) Ratio of polychromatic to normochromatic erythrocytes ( p/n)
ODB-2 failed to cause any significant decreases in the ratio of polychromatic to normochromatic erythrocytes. Mitomycin C caused statistically significant decreases in the ratio. - Conclusions:
- It is concluded from the results obtained that ODB-2 shows no evidence of mutagenic potential or bone marrow cell toxicity when administered as a single oral dose in this in vivo test procedure.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
None of the studies undertaken, Ames, Chromosome Aberrations, Mouse Lymphoma Assay and Mouse Micronucleus, demonstrated that ODB-2 exhibits genetic toxicity therefore Black 400 will not be classified for genetic toxicity.
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