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EC number: 215-355-9 | CAS number: 1323-42-8
- 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
Toxicity to reproduction
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1988-July 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Fertility measures added to a 13 week repeated dose toxicity study
- Principles of method if other than guideline:
- Fertility measures and pathology assessment of reproductive organs added to a guideline 13-week repeated dose toxicity study
- GLP compliance:
- not specified
- Remarks:
- Peer reviewed
- Limit test:
- no
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- Castor oil (CAS 8001-79-4), lot #L-5G30-01, was obtained from Cas Chemical, Inc., Bayonne, NJ. Purity analysis indicated that it was consistent with the USP specifications and the reported composition for castor oil: Analysis was conducted by Midwest Research Institute (MRI), in Kansas City, MO, utilizing infrared, UV/Vis and NMR spectroscopy, Karl Fischer water analysis, TLC and HPLC, and a battery of USP standard analyses for castor oil.
The stability of the test material during the toxicology studies was monitored by determination of peroxide content and by HPLC. The substance was stable during the course of the studies.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Simonsen Laboratories, Gilroy, CA
6 weeks of age
held 14-15 days in quaranteen after receipt and before dosing
Rats housed 5/cage, mice housed individually
Polycarbonate with heat-treated wood chips
NIH-07 diet, ad libitum. Water ad libitum
Temp-68-76°F; relative humidity-42-72%; fluorescent light 12 h/d; 10 room air changes/h.
Animals were observed twice daily, weighed initially and weekly thereafter.
10 rats/sex/group in the core study.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: rat chow (NIH 07 diet)
- Details on exposure:
- Formulated diets were prepared from a premix of castor oil with a small quantity of feed (NIH-07 diet). The premix was then blended with additional food using a twin shell blender. Homogeneity of castor oil in feed was documented by gravimetric analysis or HPLC. Diets were 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 the rodent cages. Formulated diets were stored for no longer than 3 weeks at 5°C, and food in hoppers were changed twice weekly.
- Details on mating procedure:
- No mating
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Periodic analysis of castor oil-formulated diets was conducted by HPLC. All but a single sample were within specifications (± 10% of target concentration); the one sample was remixed before being given to animals. The range of analyses was 97% to 106% of target concentration.
- Duration of treatment / exposure:
- Food with added test material was available ad libitum, daily
- Frequency of treatment:
- daily
- Details on study schedule:
- Dosing was performed daily for 13 weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.62 other: % in diet
- Remarks:
- Approximately equivalent to 400 mg/kg bw/d (nominal)
- Dose / conc.:
- 1.25 other: % in diet
- Remarks:
- Approx equal to 800 mg/kg bw/d (nominal)
- Dose / conc.:
- 2.5 other: % in diet
- Remarks:
- Approx equal to 1500 mg/kg bw/d (nominal)
- Dose / conc.:
- 5 other: % in diet
- Remarks:
- approximately equal to 3000 mg/kg bw/d (nominal)
- Dose / conc.:
- 10 other: % in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
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: No. By cage, with 5 animals/cage.
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes - Oestrous cyclicity (parental animals):
- In Females, vaginal cytology was evaluated on core-study animals during the week just preceding necropsy, using the procedure of Morrissey, et.al., 1988. 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 cover slips applied. The relative preponderance of leukocytes, nucleated epithelial cells and large squamous cells were used to identify the stages of the estrual cycle.
- Sperm parameters (parental animals):
- In males, sperm motility and morphology were evaluated on core-study at necropsy, according to Morrissey, et.al., 1988. The left epididymis was removed and quickly weighed; the cauda epididymis was removed at the junction of the vas deferens and the corpus epididymis, then weighed. A small cut was made in the distal cauda epididymis, from which the sperm were removed, and dispersed. The number of moving and non-moving sperm were counted in 5 fields of 30 sperm or less on each slide. After sperm sampling, the cauda was placed in phosphate buffered saline (PBS) and gently chopped. The solution was mixed gently and heat fixed at 65 deg C. Sperm density was then determined using a hemocytometer.
The left testes was frozen and stored. After thawing, testicular spermatid head count was determined by removing the tunica albuginea and homogenizing in PBS containing 10% DMSO. Homogenization spermatid nuclei were counted using a hemocytometer; the data were expressed as spermatid heads per total testis and per gram of testis. - Litter observations:
- not applicable
- Postmortem examinations (parental animals):
- The following reproductive tissues were routinely processed for preparation of histologic sections and microscopic examination: epididymis, seminal vesicles, prostate and testes in males, and ovaries and uterus in females. A complete histopathologic examination was conducted on all rats and mice from the control and 10% dose groups.
- Postmortem examinations (offspring):
- not applicable
- 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).
- Offspring viability indices:
- not applicable
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Description (incidence and severity):
- Not specifically examined, although clinical chemistry values are consistent with a high lipid diet.
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Hematological: males: statistically significant decrease in males in MCV in the 10% group, transient decrease in MCHC in males in the 10% group, decrease in the MCH in males of the 5 and 10% group, decreased platelets in the 1.25%, 5.0% and 10% groups. In females, there was a transient decrease in reticulocytes in the 0.62% and 10.0% groups. These effects were not biologically significant.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At days 5, 21 and 90, in males and females, there was a consistent dose-related increase in serum alkaline phosphatase activity in the 5 and 10% groups. Total bile acids were also statistically significantly elevated in males of the 5 and 10% groups at 5, 21 and 90 days. This is likely an adaptation to increased absorption and metabolism of lipids from the intestinal tract.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
In males in the highest dose group (10%), there was a statistically significant decrease in MCV; this was not considered biologically significant. Also in this group, there was a slight decrease in MCH and the MCHC was transiently decreased at day 21. Other minor effects were observed in hematologic parameters: at 90 days, the platelet count in males of the 1.25, 5 and 10% groups was significantly increased. These variations were evaluated as not biologically significant by the study authors.
Serum alkaline phosphatase activity was increased in a treatment- and dose-related manner at days 5, 21 and 90, in both males and females in the 5 and 10% groups. Total bile acids were also statistically significantly elevated in males of the 5 and 10% groups at 5, 21 and 90 days. This is likely an adaptation to increased absorption and metabolism of lipids from the intestinal tract.
Histological examination revealed an absence of compound related lesions in any organ or tissue of rat exposed to castor oil in the diet.
The NOAEL was 10% in the diet, equivalent in females to 5725 mg/kg bw/d, and in males to 5835 mg/kg bw/d.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 6 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects were observed at the highest dose tested (10% Castor oil in the diet, equivalent to 6000 mg/kg bw/d). The NOAEL is > 6000 mg/kg bw/d.
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- 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:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Details on results (F1)
Effect levels (F1)
- Key result
- Dose descriptor:
- other: No F1 generation established
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Any other information on results incl. tables
There were no observed clinical effects of dietary administration of castor oil to F344 rats for 13 weeks. The administration of diets containing up to 10% castor oil was not associated with toxicity to any specific organ, organ system or tissue, including reproductive organs, under the conditions of this study. There were no effects on sperm morphology or function in males, nor on estrous cycling in females.
Actual Dosage of Test Material in Rats
Sex |
Target Concentration (% in feed) |
Feed Consumption (g/kg bw/d) |
Test Material Consumption (mg/kg bw/d) |
Males |
0 |
65 |
0 |
|
0.62 |
65 |
404 |
|
1.25 |
65 |
809 |
|
2.5 |
63 |
1583 |
|
5 |
61 |
3067 |
|
10 |
58 |
5835 |
|
|
|
|
Females |
0 |
64 |
0 |
|
0.62 |
65 |
401 |
|
1.25 |
64 |
797 |
|
2.5 |
63 |
1569 |
|
5 |
61 |
3045 |
|
10 |
57 |
5725 |
Applicant's summary and conclusion
- Conclusions:
- The effects of dietary administration of castor oil on the reproductive organs and estrous cycle of F344 rats were investigated in a U.S. NTP guideline repeated dose toxicity study. Diets containing up to 10% castor oil for 13 weeks were not associated with toxicity to reproductive organs, organ systems/ tissues, or reproductive function, under the conditions of this study. The NOAEL is greater than 10% in the diet, equivalent to 5725 mg/kg bw/d in females, 5835 mg/kg bw/d in males (actual).
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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