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EC number: 293-170-2 | CAS number: 91052-13-0
- 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)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- April - July, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance 8001-79-4. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- : no ophthalmoscopy, no neurology
- GLP compliance:
- yes
- Limit test:
- no
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
- 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
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, USA)
- Age at study initiation: 6 weeks
- Weight at study initiation: male: 22.6 - 23.0 g, female: 17.2 - 17.7 g
- Fasting period before study:
- Housing: individually in Polycarbonate cages lined with heat-treated hardwood chips, covered with polyester filter sheets.
- Diet (e.g. ad libitum): Control feed (NIH 07) or diet formulations of castor oil were available ad libitum; feeders were changed twice per week throughout the study.
- Water (e.g. ad libitum): automatic watering system
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-76°F
- Humidity (%): 42% to 72%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Formulated diets were prepared by blending the appropriate amount of castor oil with a small quantity of feed to prepare a premix. The premix then was layered between the required amount of feed in a twin-shell blender and blended for 15 minutes to achieve a uniform mix. The homogeneity of castor oil in feed at 10% (100 mg/g) was determined by gravimetric analysis, and blends at 0.5% (5 mg/g) were determined by HPLC analysis. These concentrations of chemical in feed were found to be homogeneously distributed by this mixing procedure. The stability of the 0.5% dose level was determined using HPLC; it was found to be stable for at least 21 days when stored in the dark at 5°C and for 3 days when stored open to air and light in a rodent cage. During the studies, formulated diets were stored for no longer than 3 weeks at 5°C; feed hoppers in the animal cages were changed twice weekly.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The results of the analyses for all dose mixtures given to the animals ranged from 97% to 106% of the target concentrations.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily ad libitum feeding
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 0.62, 1.25, 2.50, 5.00, 10.0 % (w/w)
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0, 917, 2022, 3800, 7823, 15017 mg/kg bw/day
Basis:
other: actual ingested: male mice
- Remarks:
- Doses / Concentrations:
0, 1153, 2282, 5009, 9627, 16786 mg/kg bw/day
Basis:
other: actual ingested: female mice
- No. of animals per sex per dose:
- 10; 10 additional rats/sex were included at each dose level for evaluation of hematological and clinical chemistry parameters at days 5 and 21.
- Control animals:
- yes, plain diet
- Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS/ CLINICAL OBSERVATIONS: Yes
- Time schedule: twice a day
BODY WEIGHT: Yes
- Time schedule for examinations: initially and 1 x wk thereafter.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: from additional rats at days 5 and 21, and at the end of study
- Anaesthetic used for blood collection: Yes, CO2
- Animals fasted: No data
- How many animals: 10 additional animals
- Parameters checked: red blood cell (RBC) count, red blood cell morphologic assessment, hematocrit (HCT), hemoglobin concentration (HGB), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), white blood cell count (WBC), white blood cell differential count, reticulocyte count (absolute), and platelet counts (absolute).
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: from additional rats at days 5 and 21, and at the end of study
- Animals fasted: No data
- How many animals: 10 additional animals
- Parameters checked: alkaline phosphatase activity (ALP), albumin (ALB), urea nitrogen (UN), creatinine (CREA), alanine aminotransferase activity
(ALT), total bile acids (TBA), sorbitol dehydrogenase activity (SDH), total protein (TP), and creatinine kinase (CK).
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Complete histopathology examinations were conducted from the control and 10% dose groups. Organ weights were determined to the nearest milligram for the liver, right kidney, right testicle, heart, thymus, and lungs. All tissues were preserved in 10% neutral buffered formalin.
The following tissues were routinely processed for preparation of histologic sections and microscopic examination: adrenal
glands, brain, cecum, colon, duodenum, epididymis/seminal vesicles/prostate/testes or ovaries/uterus, esophagus, eyes (if
grossly abnormal), femur (including marrow), heart, ileum, jejunum, kidneys, liver, lungs and mainstem bronchi, mammary
gland, mandibular and mesenteric lymph nodes, nasal cavity and turbinates, pancreas, parathyroid glands, pituitary gland,
preputial or clitoral glands, rectum, salivary glands, skin, spinal cord and sciatic nerve (if neurologic signs present), spleen,
forestomach and glandular stomach, thymus, thyroid gland, trachea, urinary bladder, zymbal glands, and all gross lesions
and tissue masses including regional lymph nodes. A complete histopathologic examination was conducted from the control and 10% dose groups. - Statistics:
- Body weight and organ weight data were statistically analyzed within each sex by one-way Analysis of Variance tests, followed by Dunnett's t-test if pair-wise comparisons were indicated (p < 0.05)(Dunnett, 1955).
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- no adverse biologically significant effects
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- no adverse biologically significant effects
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No effects
BODY WEIGHT AND WEIGHT GAIN
Mean body weights of exposed male mice generally were lower than controls, while mean body weights of exposed females generally were higher. There were no obvious indications that these differences were related to dietary concentrations of castor oil, except that mean body weights of male mice receiving the 10% castor oil diet were consistently lower than those of control mice from week 3 through the end of the study.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
No significant differences in average food consumption among each sex were observed, although food consumption by female mice receiving diets containing 10% castor oil was slightly lower than controls.
HAEMATOLOGY
No changes were observed.
CLINICAL CHEMISTRY
No changes were observed.
ORGAN WEIGHTS
Liver weights were increased in male and female mice that received diets containing 5% or 10% castor oil. Kidney weights were increased in female mice that received 5% or 10% diets. Using light microscopy, it was determined that there were no morphologic changes associated with the slight differences between groups in organ weights. Histopathologic examination revealed an absence of compound-related lesions in any organs or tissues of mice exposed to castor oil in the diet.
OTHER FINDINGS
Castor oil exposure produced no adverse effects on any male (testes weight, epididymal sperm motility, density, or testicular spermatid head count) or female (estrual cycle length, or time spent in each phase of the cycle) reproductive parameter among mice. The low value for sperm motility in control mice was attributed to poor preparative technique.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 15 000 mg/kg bw/day (actual dose received)
- Based on:
- other: calculated test material intake based on food consumption and body weight
- Sex:
- male/female
- Basis for effect level:
- other: mice; based on clinical signs; mortality; body weight; food consumption; haematology; clinical chemistry; gross pathology; organ weights; histopathology;
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- After 90 days oral feeding a NOAEL of 15000 mg/kg bw/day for mice could be identified.
- Executive summary:
Castor oil is a natural oil derived from the seeds of the castor bean, Ricinus communis. It is comprised largely of triglycerides with a high ricinolin content. Toxicity studies with castor oil were performed by incorporating the material at concentrations as high as 10% in diets given to B6C3F1 mice of both sexes for 13 weeks.
Exposure to castor oil at dietary concentrations as high as 10% in 13-week studies did not affect survival or body weight gains of mice (10 per sex and dose). Liver weights were increased in male and female mice receiving diets containing 5% or 10% castor oil. However, there were no histopathologic lesions associated with these liver changes, nor were there any compound-related morphologic changes in any organ. No significant changes were noted in a screening for male reproductive endpoints, including sperm count and motility, and no changes were observed in the length of estrous cycles of rats or mice given diets containing castor oil. Thus, no adverse effects of castor oil administration were noted in these studies.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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