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EC number: 294-585-1 | CAS number: 91744-23-9
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- publication
- Title:
- NTP Technical Report on the Toxicity Studies of Castor Oil in F344/N Rats and B6C3F1 Mice (Dosed Feed Studies).
- Author:
- Irwin, R.
- Year:
- 1 992
- Bibliographic source:
- National Toxicology Program (NTP TOX 12 NIH Publication No. 92 -3131). National Institutes of Health.
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test:
Mice (10/sex/dose) received diets containing 0, 0.62%, 1.25%, 2.5%, 5.0% or 10% castor oil, continuously for 13 weeks. Ten additional rats/sex were included at each dose level for evaluation of hematological and clinical chemistry parameters. At days 5 and 21, these animals were anesthetized with carbon dioxide, and blood was collected from the orbital sinus. These animals were killed following the blood collection on day 21.Smears were prepared from peripheral blood samples obtained by cardiac puncture of dosed and control animals at the termination of the 13 week study. Slides were stained with Hoechst 33258/pyronin Y. At least 2000 PCE and 10000 NCE from each animal were scored for micronuclei.
- Short description of test conditions: Mice were housed individually. Polycarbonate cages lined with heat-treated hardwood chips and covered with polyester filter sheets were used; the cages were stored on stainless steel racks equipped with an automatic watering system. Temperature in the animal room was maintained within 68-76°F; relative humidity ranged from 42% to 72%. Incoming air was filtered to remove particulates, and a flow rate was maintained to ensure complete exchange at least 10 times per hour. A controlled light cycle of 12 hours of daylight and 12 hours of darkness was maintained. Control feed or diet formulations of castor oil were available ad libitum; feeders were changed twice per week throughout the study.
- Parameters analysed / observed: Smears were prepared from peripheral blood samples obtained by cardiac puncture of dosed and control animals at the termination of the 13 week study. Slides were stained with Hoechst 33258/pyronin Y. At least 2000 PCE and 10000 NCE from each animal were scored for micronuclei. - GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 8001-79-4
- Cas Number:
- 8001-79-4
- IUPAC Name:
- 8001-79-4
- Reference substance name:
- Castor oil
- EC Number:
- 232-293-8
- EC Name:
- Castor oil
- IUPAC Name:
- 232-293-8
- Reference substance name:
- Castor oil
- IUPAC Name:
- Castor oil
- Details on test material:
- - Name of test material (as cited in study report): Castor Oil
- Synonyms: Ricinus Oil, oil of Palma Christi, tangantangan oil, phorboyl, Neoloid
- Composition of test material, percentage of components: Triglyceride of fatty acids. Fatty acid composition is approximately 87% ricinoleic,
7% oleic, 3% linoleic, 2% palmitic, 1% stearic, and trace amounts of dihydroxystearic.
- Analytical grade: USP AA grade
- Source: Cas Chemical, Inc. (Bayonne, NJ, USA)
- Stability: The stability of the study material during the toxicology studies was monitored by determination of peroxide content and by high performance liquid chromatography. No deterioration of the castor oil study material was observed over the course of the studies.
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- USP AA grade castor oil was obtained in one lot (#L-5G30-01) from Cas Chemical, Inc. (Bayonne, NJ). Purity and identity analyses were conducted by Midwest Research Institute (MRI) (Kansas City, MO). MRI reports on the analyses performed in support of the castor oil studies are on file at the National Institute of Environmental Health Sciences (Research Triangle Park, NC).
Cumulative data indicated a purity consistent with the USP specifications and the reported composition for castor oil.
The stability of the study material during the toxicology studies was monitored by determination of peroxide content and by high performance liquid chromatography. No deterioration of the castor oil study material was observed over the course of the studies.
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Details on species / strain selection:
- Obtained from Simonsen Laboratories (Gilroy, CA, USA).
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mice were housed individually. Polycarbonate cages lined with heat-treated hardwood chips and covered with polyester filter sheets were used; the cages were stored on stainless steel racks equipped with an automatic watering system. Temperature in the animal room was maintained within 68-76°F; relative humidity ranged from 42% to 72%. Incoming air was filtered to remove particulates, and a flow rate was maintained to ensure complete exchange at least 10 times per hour. A controlled light cycle of 12 hours of daylight and 12 hours of darkness was maintained. Control feed or diet formulations of castor oil were available ad libitum; feeders were changed twice per week throughout the study.
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- Ad libitum.
- Duration of treatment / exposure:
- 13 continuous weeks.
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: %
- Dose / conc.:
- 0.62 other: %
- Dose / conc.:
- 1.25 other: %
- Dose / conc.:
- 2.5 other: %
- Dose / conc.:
- 5 other: %
- Dose / conc.:
- 10 other: %
- No. of animals per sex per dose:
- 10/sex/concentration.
- Control animals:
- yes, plain diet
- Positive control(s):
- Male mice treated for 4 weeks with urethane in the drinking water (0.2%). These animals were not part of the 13-week study, but were added as a measure of quality control for the assay.
Examinations
- Tissues and cell types examined:
- Complete histopathology examinations were conducted on all mice from the control and 10% dose groups.
- Details of tissue and slide preparation:
- Smears were prepared from peripheral blood samples obtained by cardiac puncture of dosed and control animals at the termination of the 13 week study. Slides were stained with Hoechst 33258/pyronin Y. At least 2000 PCE and 10000 NCE from each animal were scored for micronuclei.
- Statistics:
- Shirley's test was used to assess any significance that were different from control groups by , p <0.05.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Frequency of Micronuclei in Peripheral Blood Erythrocytes of B6C3F1 Mice Exposed to Castor Oil in Dosed Feed for 13 Weeks
Percent in Feed | % Normachromatic erythrocytes with micronuclei | % Polychromatic erythrocytes with micronuclei | Number of mice |
Male mice: | |||
0 | 0.11 ± 0.02 | 1.20 ± 0.08 | 10 |
0.6 | 0.13 ± 0.02 | 1.18 ± 0.10 | 10 |
1.3 | 0.11 ± 0.01 | 1.16 ± 0.09 | 10 |
2.5 | 0.13 ± 0.01 | 1.24 ± 0.10 | 10 |
5.0 | 0.09 ± 0.02 | 1.40 ± 0.11 | 9 |
10 | 0.09 ± 0.01 | 1.21 ± 0.08 |
10 |
Female mice | |||
0 | 0.10 ± 0.01 | 1.18 ± 0.07 | 10 |
0.6 | 0.09 ± 0.01 | 1.21 ± 0.10 | 10 |
1.3 | 0.07 ± 0.01 | 1.11 ± 0.08 | 9 |
2.5 | 0.09 ± 0.02 | 1.11 ± 0.08 | 10 |
5.0 | 0.09 ± 0.01 | 1.49 ± 0.18 | 10 |
10.0 | 0.06 ± 0.01 | 1.00 ± 0.10 | 10 |
Urethane | |||
0.2% | 1.68 ± 0.25 | 1.710 ± 0.25 | 3 |
Applicant's summary and conclusion
- Conclusions:
- Castor oil was found to be negative for cytogenicity as evidenced by a lack of micronuclei in peripheral blood erythrocytes of B6C3F1 mice exposed in dosed feeding for 13 weeks.
- Executive summary:
B6C3F1 mice (10/sex/dose) received diets containing 0, 0.62%, 1.25%, 2.5%, 5.0% or 10% castor oil, continuously for 13 weeks. Ten additional rats/sex were included at each dose level for evaluation of hematological and clinical chemistry parameters. At days 5 and 21, these animals were anesthetized with carbon dioxide, and blood was collected from the orbital sinus. These animals were killed following the blood collection on day 21.Smears were prepared from peripheral blood samples obtained by cardiac puncture of dosed and control animals at the termination of the 13 week study. Slides were stained with Hoechst 33258/pyronin Y. At least 2000 PCE and 10000 NCE from each animal were scored for micronuclei. Castor oil was found to be negative for cytogenicity as evidenced by a lack of micronuclei in peripheral blood erythrocytes of B6C3F1 mice exposed in dosed feeding for 13 weeks.
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