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Diss Factsheets
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EC number: 293-411-1 | CAS number: 91079-24-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP complaint, guideline study with minor restrictions, adequate for assessment. For read across justification see Section 13.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- 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 (MacGregor et al., 1983). At least 2000 PCE and 10000 NCE from each animal were scored for micronuclei.
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Castor oil
- EC Number:
- 232-293-8
- EC Name:
- Castor oil
- Cas Number:
- 8001-79-4
- IUPAC Name:
- 8001-79-4
- Details on test material:
- - Name of test material (as cited in study report): Castor oil
- Lot/batch No.: L-5G30-01
- Molecular formula (if other than submission substance): C55 H100 O9
- Molecular weight (if other than submission substance): 905.41
- Smiles notation (if other than submission substance): O=C(CCCCCCC=CCC(CCCCCC)O)OC(COC(=O)(CCCCCCCC=CCC(O)CCCCCC))C(=O)(OCCCCCCCC=CCC(O)CCCCCC)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Simonsen Laboratories, Gilroy, CA
- Age at study initiation: 6 weeks
- Weight at study initiation: No data
- Assigned to test groups randomly: Yes, weight randomised
- Fasting period before study: No
- Housing: Individually caged
- Diet (e.g. ad libitum): Yes, NIH 07 standard rodent diet, ad libitum
- Water (e.g. ad libitum): Yes, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 42 - 72
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: April 1988 To: July 1988
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- Not applicable
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): No data but no longer than 21 days (limit of stability)
- Mixing appropriate amounts with (Type of food): A premix of the substance and powdered diet was prepared for each dosed feed formulation. Additional portions of feed were added and the premix stirred after each addition. For the final preparation, the premix and additional feed were layered in a twin-shell blender and blended for 15 minutes
- Storage temperature of food: 5 deg C, in the dark - Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Continuous (via diet)
- Post exposure period:
- None
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.00, 0.62, 1.25, 2.50, 5.00 and 10.00%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0, 1035, 2152, 4404, 8725 and 15901 mg/kg body weight/day
Basis:
other: average of individual consumption values
- No. of animals per sex per dose:
- 10 males / 10 females
- Control animals:
- yes, plain diet
- Positive control(s):
- Male mice treated for 4 weeks with urethane in the drinking water (0.2%).
Examinations
- Tissues and cell types examined:
- Erythrocytes
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES: Following 13 weeks exposure
DETAILS OF SLIDE PREPARATION: Slides stained with Hoechst 33258/pyronin Y
METHOD OF ANALYSIS: Microscopic examination of stained slides, at least 2000 PCE and 10000 NCE from each animal scored for micronuclei. - Statistics:
- Significance of any difference from controls assessed using Shirley's test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- not specified
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
No induction of micronuclei was observed in peripheral blood erythrocytes of male and female B6C3F1 mice sampled on termination of a 13-week repeated dose toxicity study following administration of the substance in the diet at concentrations of up to 10%. - Executive summary:
No induction of micronuclei was observed in peripheral blood erythrocytes of male and female B6C3F1mice sampled on termination of a 13-week repeated dose toxicity study following administration of the substance in the diet at concentrations of up to 10%.
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