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EC number: 442-640-7 | CAS number: -
- 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 vivo
Description of key information
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-02-27 to 2002-04-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH Gartenstrasse 27, 33178 Borchen
- Age at study initiation: 6 weeks
- Weight at study initiation: mean male: 190.6 g; mean female: mean= 149.9 g
- Housing: five animals per cage in transparent macrolon cages (type IV) on soft wood granulate in an air-conditioned room (room number 011)
- Diet (e.g. ad libitum): rat/mice diet ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12h light/dark - Route of administration:
- oral: gavage
- Vehicle:
- deionized water
- Duration of treatment / exposure:
- 24 h
- Frequency of treatment:
- two doses separated by an interval of 24 hours (except positive control with only one dose)
- Remarks:
- Doses / Concentrations:
2000 mg/kg
Basis:
no data - No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- The positive control was with Endoxan, which was administered once orally at a dose of 40 mg per kg body weight.
- Tissues and cell types examined:
- bone marrow: 2000 polychromatic erythrocytes were counted for each animal
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Based on the results of the acute oral toxicity-study PTOl-0361 the dose of 2000 mg/kg bw was selected as the limit dose
DETAILS OF SLIDE PREPARATION:
bone marrow smaples were fentrifuged with fetal bovine serum, sediment was smeared and stained as follows:
Staining procedure
-5 minutes in methanol
-5 minutes in May-Griinwald' s solution
-brief rinsing twice in distilled water
-10 minutes staining in 1 part Giemsa solution to 6 parts buffer solution, pH 7.2 (Weise) rinsing in distilled water
-drying
-coating with Entellan®
METHOD OF ANALYSIS:
2000 polychromatic erythrocytes were counted for each animal. The number of cells with micronuclei was recorded - Evaluation criteria:
- Criteria for a positive response:
A substance is considered as positive if there is a dose-related increase in the number of micronucleated polychromatic erythrocytes or a significant increase in at least one dose group compared with the concurrent negative control group which is above the range of the historical control data. A test substance producing no significant or dose-related increase in the number of micronucleated polychromatic erythrocytes is considered non-clastogenic in this system. - Statistics:
- Assuming the study is valid based on a monotone-dose-relationship, one-sided Wilcoxon tests were performed initially comparing control values with those of the highest dose group. A significance level of 5% is adopted for all tests.
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- There was a slight increase in micronucleated polychromatic erythrocytes in male animals, but was within the historical control range of the negative control groups and was concluded to have no biological relevance.
- Conclusions:
- Interpretation of results (migrated information): negative
Reactive Olive F00-0149 did not cause a substantial increase of micronucleated polychromatic erythrocytes and is therefore not considered clastogenic in the micronucleus test in vivo. - Executive summary:
In a Sprague-Dawley rat bone marrow micronucleus assay, 15 rats/sex were treated orally with two doses, 24 hours apart, of Reactive Olive at 2000 mg/kg bw. Bone marrow cells were harvested 24h post-treatment. The vehicle was deionized water.
There were no signs of substance-related toxicity during the study. The positive control induced the appropriate response. There was not a significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after treatment.
This study is classified asacceptable and satisfies the requirement for Test Guideline OPPTS 870.5395; OECD 474 for in vivo cytogenetic mutagenicity data.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In a reverse gene mutation assay in bacteria, strains TA 98, TA 100, TA 1535, TA 1537 of S. typhimurium and E. colli WP2 uvrA were exposed to Reactive Olive F00-0149 in water at concentrations of 50, 160, 500, 1600, and 5000 ug/plate in the presence and absence of metabolic activation. There was evidence of a significant dose-response increase in the number of revertant colonies in the presence of metabolic activation with strain TA 98 at the highest dose and a slight increase in the number of reverant colonies with strain TA 1535 at the highest dose. In this study, the test item is mutagenic in bacteria in the presence of metabolic activation using the standard Ames Test procedure (plate incorporation test).
Additionally, in a mammalian cell cytogenetics assay (chromosome aberration), Chinese hamster lung fibroblasts (V79) were exposed to Reactive Olive F00-0149 in test medium at concentrations of 1000, 2500, 3750,5000 µg/mL, with and without metabolic activation for 3h and at concentrations of 250, 500, 1000, 1500, 2000 µg/mL without metabolic activation for 20h. Results show significantly enhanced aberration rates at the 3h treatment time with S9-mix at 2500 and 5000 ug/mL. Further, there was an increase in polyploidy cells at the highest dose with and without S9-mix. There was also a slight increase in the number of aberrations compared to historical controls without S9-mix at 2500 ug/mL. This experiment indicated there was evidence of chromosome aberration induced over background in the absence and presence of metabolic activation.
In a mammalian cell gene mutation assay, Chinese hamster lung fibroblast (V79) cells cultured in vitro were exposed to Reactive Olive F00-0149 in culture medium at concentrations 10, 50, 100, 250, 500, 1000, 2500 and 5000 µg/mL in the presence and absence of mammalian metabolic activation S9. The test item did not induce gene mutations, i.e. was not mutagenic, either in the presence or in the absence of metabolic activation under the conditions described in this report.
Finally, in a Sprague-Dawley rat bone marrow micronucleus assay, 15 rats/sex were treated orally with two doses, 24 hours apart, of Reactive Olive F00-0149 at 2000 mg/kg bw in deionized water. Bone marrow cells were harvested 24h post-treatment. This test concluded no signs of substance-related toxicity during the study as well as no significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after treatment. The test item is therefore not considered clastogenic in the micronucleus test in vivo.
In summary, two in vitro experiments (Ames test and in vitro CA) indicated genetic toxicity induced by Reactive Olive F00-0149. The effects have been invalidated by a higher tier gene mutation assay in mammalian cells (HPRT) and an in vivo micronucleus test in rat. Based on the weight of evidence, the test item is not considered genotoxic in an appropriate testing battery.
Justification for selection of genetic toxicity endpoint
In vivo genetic toxicity study according to OECD 474 for in vivo cytogenicity. Additionally, several in vitro studies are available for genetic toxicity of Reactive Olive F00-0149
Justification for classification or non-classification
The test item is not considered genotoxic based on a weight of evidence assessment of the results of an appropriate testing battery.
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