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EC number: 941-732-9 | 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
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP status not known. Adequate for assessment.
- Justification for type of information:
- Read across justification included in Section 13
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP status not known. Adequate for assessment.
- Justification for type of information:
- Read across justification included in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- Male and female CD-1 mice received catalytically clarified oil as two consecutive daily doses, either by gavage or i.p. injection. Animals were sacrificed 24 hr after the second treatment. Bone marrow cells were then collected and mature red blood cells (normochromatic erythrocytes, NCE) and immature red cells (polychromatic erythrocytes, PCE) evaluated for cytotoxicity and micronucleus formation.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Canada (Quebec, Canada)
- Age at study initiation: 6-9 wk
- Weight at study initiation: 17-35 g - Route of administration:
- oral: gavage
- Vehicle:
- Vehicle: corn oil
- Details on exposure:
- Dose selection was based on a range-finding (toxicity) study (0, 1, 2 or 3 g/Kg bw)
- Duration of treatment / exposure:
- 2 consecutive daily doses, with sacrifice 24 hr after second dose
- Frequency of treatment:
- daily for 2 days
- Post exposure period:
- 24 hr
- Remarks:
- Doses / Concentrations:
0, 188, 375, 750 or 1500 mg/Kg bw/d
Basis:
nominal conc. - No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide, 40 mg/Kg bw (gavage in water)
- Tissues and cell types examined:
- Bone marrow smears (femur) were prepared from five animals per sex per dose group, stained with acridine orange and examined under fluorescence microscopy. One thousand erythrocytes were evaluated per animal and the total number PCEs and NCEs recorded. One thousand PCEs were evaluated for the presence of micronuclei.
- Statistics:
- Data were analysed using ANOVA followed by Duncan's Multiple Range Test. Regression analysis was used to characterise any dose-response relationship present.
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results (migrated information): negative
Catalytically cracked clarified oil did not induce micronucleated polychromatic erythrocytes in mouse femoral bone marrow following two consecutivedaily oral doses of 188-1500 mg/Kg bw/d. - Executive summary:
The clastogenic potential of catalytically cracked clarified oil was evaluated in male and female mice after 2 consecutive daily oral treatments of 0, 188, 375, 750 ot 1500 mg/Kg bw/d. Femoral bone marrow was collected 24 hr following the second treatment, and polychromatic erythrocytes present evaluated for micronucleus formation.
Catalytically cracked clarified oil was not cytotoxic (as judged from no change in the PCE:NCE ratio) nor did it induce any statistically significant increase in the formation of micronucleated PCEs. An absence of cytotoxicity may indicate that the test substance did not reach the target tissue.
There was no significant increase in the percentages of micronucleated PCE 24 hr after 2 consecutive daily doses of catalytically cracked clarified oil at doses of 188, 375, 750 or 1500 mg/Kg bw/d:
Control = 1.3 / 1000 PCE
188 mg/Kg bw = 1.8 / 1000 PCE
375 mg/Kg bw = 1.8 / 1000 PCE
750 mg/Kg bw = 3.0 / 1000 PCE
1500 mg/Kg bw = 2.3 / 1000 PCE
The mean percentage of PCEs for treated animals was 49-54% versus 50-55% for the controls i.e. there was no evidence of cytotoxicity and it is not known if the test substance reached the target tissue (guideline criterion).
A satisfactory response was obtained with the positive control substance (cyclophosphamide).
Data source
Reference
- Reference Type:
- publication
- Title:
- Assessment of the utility of the micronucleus test for petroleum-derived materials
- Author:
- Przygoda, R.T., McKee, R.H., Amoruso, M.A. and Freeman, J.J.
- Year:
- 1 999
- Bibliographic source:
- Mutation Research 438, 145-153
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- Male and female CD-1 mice received catalytically clarified oil as two consecutive daily doses, either by gavage or i.p. injection. Animals were sacrificed 24 hr after the second treatment. Bone marrow cells were then collected and mature red blood cells (normochromatic erythrocytes, NCE) and immature red cells (polychromatic erythrocytes, PCE) evaluated for cytotoxicity and micronucleus formation.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 64741-62-4
- IUPAC Name:
- 64741-62-4
- Test material form:
- other: Viscous hydrocarbon liquid
- Details on test material:
- - Name of test material (as cited in study report): catalytically cracked clarified oil
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Canada (Quebec, Canada)
- Age at study initiation: 6-9 wk
- Weight at study initiation: 17-35 g
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Vehicle: corn oil
- Duration of treatment / exposure:
- 2 consecutive daily doses, with sacrifice 24 hr after second dose
- Frequency of treatment:
- daily for 2 days
- Post exposure period:
- 24 hr
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 188, 375 or 750 mg/Kg bw/d
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 750, 1500 or 3000 mg/Kg bw/d
Basis:
nominal conc.
- No. of animals per sex per dose:
- Study 1 (188-750 mg/Kg bw/d): 5 male, 5 female per dose level
Study 2 (750-3000 mg/Kg bw/d): 2 male, 2 female per dose level - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide, 40 mg/Kg bw (gavage in water)
Examinations
- Tissues and cell types examined:
- Bone marrow smears (femur) were prepared from five animals per sex per dose group, stained with acridine orange and examined under fluorescence microscopy. One thousand erythrocytes were evaluated per animal and the total number PCEs and NCEs recorded. One thousand PCEs were evaluated for the presence of micronuclei.
- Statistics:
- Data were analysed using ANOVA followed by Duncan's Multiple Range Test. Regression analysis was used to characterise any dose-response relationship present.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- in both studies
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
There was no significant increase in the percentages of micronucleated PCE 24 hr after 2 consecutive daily doses of catalytically cracked clarified oil at doses of 188 -750 or 750 -3000 mg/Kg bw/d. Results for study 2 were as follows:
Control = 1.25 / 1000 PCE
750 mg/Kg bw = 1.75 / 1000 PCE
1500 mg/Kg bw = 2.50 / 1000 PCE
3000 mg/Kg bw = 1.00 / 1000 PCE
The mean percentage of PCEs was decreased for treated animals from study 2 as follows:
Control = 48.8%
750 mg/Kg bw/d = 41.3%
1500 mg/Kg bw/d = 36.8%
3000 mg/Kg bw/d = 32.4%
(historical control range = 45 -59%)
The decrease in mean percentage PCE indicates that the test substance reached the target tissue (guideline criterion).
A satisfactory response was obtained with the positive control substance (cyclophosphamide).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Catalytically cracked clarified oil did not induce micronucleated polychromatic erythrocytes in mouse femoral bone marrow following two consecutive daily i.p. treatments of up to 3000 mg/Kg bw/d. - Executive summary:
The clastogenic potential of catalytically cracked clarified oil was evaluated in male and female mice following 2 consecutive daily treatments of up to 3000 mg/Kg bw/d. Femoral bone marrow was collected 24 hr following the second treatment, and polychromatic erythrocytes present evaluated for micronucleus formation. Mild cytotoxicity (as indicated by a decrease in the percentage of PCE present) was apparent following treatments of 1500 and 3000 mg/Kg bw/d but there was no increased formation of micronucleated PCEs.
The results indicate the catalytically cracked clarified oil is not clastogenic in mouse bone marrow following i.p. administration at doses up to 3000 mg/Kg bw/d.
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