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EC number: 269-123-7 | CAS number: 68187-76-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study on a structurally similar substance conducted in accordance with recognised test guidelines. 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 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- 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
- 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:
- rat
- Strain:
- Fischer 344
- 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
- Fasting period before study: n/a
- Housing: 5/sex/cage
- Diet (e.g. ad libitum): NIH-07 open formula diet, ad libitum
- Water (e.g. ad libitum): 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
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): No data but no loner 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 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Homogeneity of the dosed feed mixtures was performed with HPLC. Stability studies were performed GC/FID. The feed mixtures were found to be stable for 3 weeks when stored in the dark at 5 deg C and for 3 days when stored under animal room conditions.
Dosed feed mixtures were periodically analysed b y HPLC. All dose formulations administered were within 10% of the theoretical concentrations. - Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Continuous in diet
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 0.62, 1.25, 2.50, 5.00 and 10.00 %
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0, 402, 803, 1576, 3056 and 5780 mg/kg/day
Basis:
other: average of individual consumption values
- No. of animals per sex per dose:
- 10 males / 10 females + 10 males / 10 females / group for evaluation of interim haematology and clinical chemistry parameters
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: No data
- Rationale for animal assignment (if not random): Random
- Rationale for selecting satellite groups: Randoma
- Post-exposure recovery period in satellite groups: n/a
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Weekly
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
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 - Measured twice weekly
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Following 5 and 21 days of treatment (satellite animals) and following 13 weeks treatment
- Anaesthetic used for blood collection: Yes (identity) - carbon dioxide
- Animals fasted: No data
- How many animals: 5 males/5 females/group on Days 5 and 21, all animals at termination?
- Parameters examined: haematocrit, haemoglobin concentration, RBC count, reticulcyte count, MCV, MCHC, platelet count, white blood cell count, differential leucocyte count.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Following 5 and 21 days of treatment (satellite animals) and following 13 weeks treatment
- Anaesthetic used for blood collection: Yes (identity) - carbon dioxide
- Animals fasted: No
- How many animals: 5 males/5 females/group on Days 5 and 21, all animals at termination?
- Parameters examined: urea nitrogen, creatinine, total protein, albumin, alanine animo transferase, alkaline phosphatase, creatine kinase, sorbitol dehydrogenase, total bile acids.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
REPRODUCTIVE TOXICITY: In females, vaginal cytology was evaluated during the week preceding necropsy. For the 12 days prior to termination females were subject to vaginal lavage with saline. The aspirated cells were air-dried onto slides, stained with Toluidine Blue O and the relative abundance of leukocytes, nucleated epithelial cells, and large squamous epithelial cells were used to identify the stages of the oestrus cycle. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. The following organs were weighed - heart, right kidney, liver, lungs, testes and thymus
HISTOPATHOLOGY: Yes. Control and high-dose groups. Examination of liver from males all treatment gruops. The following were examined - adrenal glands, brain, caecum, colon, duodenum, epididymides/seminal vesicles/prostate/testes, ovaries/uterus, oesophagus, femur (including marrow), heart, ileum, jejunum, kidneys, liver, Lungs and mainstem bronchi, lymph nodes (mandibular and mesenteric), nasal cavity with turbinates, pancres, parathyroid glands, pituitary gland, preputial or clitoral glands, rectum, salivary glands, skin, spinal cord and sciatic nerve (if neurologic signs present), spleen, stomach, thymus, thyroid, trachea, urinary bladder, zymbal glands, gross abnormalities
REPRODUCTIVE TOXICITY: Sperm motility and morphology were evaluated at necropsy. The left epididymis was removed and weighed; the cauda epididymis was removed at the junction of the vas deferens and the corpus epididymis and weighed. A small cut was made in the distal cauda epididymis and the sperm that were removed from the epididymis were dispersed and the number of moving and non-moving sperm were counted in 5 fields of 30 sperm or less on each slide. After sperm sampling for motility evaluation, the cauda was placed in phosphate buffered saline and gently chopped. The solution was mixed gently and heat-fixed at 65°C. Sperm density was then determined using a haemocytometer. The left testis was frozen and stored. After thawing, testicular spermatid head count was determined by removing the tunica albuginea and homogenising the testis in phosphate buffered saline containing 10% DMSO. Homogenisation spermatid nuclei were counted using a haemocytometer. - Statistics:
- Body weight and organ weight analysed by one-way ANOVA followed by Dunnett's t-test
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):
- Slightly reduced in females at 10%
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Slightly reduced in males and females at 10%
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Increased AP
- 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):
- Liver weight increased in males at 10%
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY - Exposure had no effect on survival.
BODY WEIGHT AND WEIGHT GAIN - Group mean body weights of treated rats were not significantly different from controls. In treated females, mean body weights were slightly lower than that of controls but the differences were not dose-related.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study) - No significant differences in food consumption were observed, although food consumption of male and female rats receiving diets containing 10% castor oil was slightly lower than that of controls.
HAEMATOLOGY – In males treated with 10% substance in the diet a slight decrease in MCHC was observed at Day 21 and there was a statistically significant decrease in MCV. A decreased MCH was noted in animals treated at concentrations of 5% and 10% and an increase in platelets was apparent in animals treated at concentrations of 1.25%, 5% and 10%. The only change noted in females was a statistically significant decrease in reticulocyte count at Day 5 in those animals treated with dietary concentrations of 0.62% or 10%. None of the changes were considered biologically significant
CLINICAL CHEMISTRY – An increase in the activity of serum alkaline phosphatase was observed in male and female rats at Days 5 and 21 and at study termination that was both treatment- and dose-related. Total bile acids were increased among males receiving higher dietary concentrations at Days 5 and 21 but this was no longer apparent at study termination. Other minor changes included increases in albumin observed at study termination in males receiving 5% diets and at Day 5 in females receiving 10% diets, and an increase in urea nitrogen at study termination in males that received 0.62% diets and a decrease at Day 5 in females that received 10% in the diet.
ORGAN WEIGHTS - Absolute and relative (to body weight) liver weights were increased in male rats treated with 10% concentration in the diet. Relative heart weight was increased in males receiving 0.62%, 2.5% and 10% diets. Absolute heart weights were not increased and the differences in body weight ratios were small and not considered treatment related.
HISTOPATHOLOGY: NON-NEOPLASTIC - Histopathologic examination did not reveal any treatment-related lesions in any organ or tissue. There were no morphologic changes associated with the slight differences observed in organ weights.
OTHER FINDINGS - Reproductive parameters: In males, a slight decrease in epididymal weight (6-7%) was observed in the middle- and high-dose groups, but this was not dose-related. There were no effects on any other male rat reproductive endpoint and no effects were seen on any female rat reproductive endpoint.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 5 780 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: clinical signs; mortality; body weight; food consumption; haematology; clinical chemistry; organ weights; histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- A 13 -week subchronic toxicity study has been undertaken on castor oil. Dietary levels of 0.00, 0.62, 1.25, 2.50, 5.00 and 10.00% (equivalent to 0, 404, 809, 1583, 3067 and 5835 mg/kg/day in males and 0, 401, 797, 1569, 3045 and 5725 mg/kg/day in females). Exposure was associated with only minimal indications of toxicity with absolute and relative liver weights increased in male rats receiving diets that contained the higher concentrations. These increases were not accompanied by corresponding histopathologic lesions or alterations in clinical chemical endpoints that would indicate hepatotoxicity. Since castor oil is composed of triacylglycerols, the increased liver weights could be a reflection of elevated metabolic activity associated with increased lipid absorption, rather than a toxic response. This conclusion is consistent with the observed increases of total bile acids in serum of male rats and of alkaline phosphatase activity in the serum of both sexes of rats. Bile acids and alkaline phosphatase (intestinal form) are both involved with intestinal absorption and metabolism of lipids, and the serum concentrations are normally increased in association with ingestion of a lipid-rich diet. Although there was some variation in epididymal weights, their small magnitude and the absence of changes in other endpoints suggested that there was little or no evidence of any reproductive toxicity associated with exposure.
- Executive summary:
A 13 -week subchronic toxicity study has been undertaken on castor oil. Dietary levels of 0.00, 0.62, 1.25, 2.50, 5.00 and 10.00% (equivalent to 0, 404, 809, 1583, 3067 and 5835 mg/kg/day in males and 0, 401, 797, 1569, 3045 and 5725 mg/kg/day in females).Exposure was associated with only minimal indications of toxicity with absolute and relative liver weights increased in male rats receiving diets that contained the higher concentrations. These increases were not accompanied by corresponding histopathologic lesions or alterations in clinical chemical endpoints that would indicate hepatotoxicity. Since castor oil is composed of triacylglycerols, the increased liver weights could be a reflection of elevated metabolic activity associated with increased lipid absorption, rather than a toxic response. This conclusion is consistent with the observed increases of total bile acids in serum of male rats and of alkaline phosphatase activity in the serum of both sexes of rats. Bile acids and alkaline phosphatase (intestinal form) are both involved with intestinal absorption and metabolism of lipids, and the serum concentrations are normally increased in association with ingestion of a lipid-rich diet. Although there was some variation in epididymal weights, their small magnitude and the absence of changes in other endpoints suggested that there was little or no evidence of any reproductive toxicity associated with exposure.
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