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EC number: 272-911-3 | CAS number: 68920-03-6 A complex combination obtained by steam distillation of C16-18 and C18-unsatd. glycerides followed by condensation of the steam.
- 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
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- other: Screening of reproductive parameters in subchronic oral toxicity study
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- From Apr. to Jul. 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A 90 d oral repeated dose study was conducted in F344/N rat to evaluate the sub-chronic toxicity of castor oil in which reproductive parameters were also screened.
Rats (10 /sex / group) were exposed for 13 weeks to 0, 0.62, 1.25, 2.5, 5.0 or 10% castor oil mixed in diet. Apart from the standard sub-chronic toxicity examinations, sperm count, motility and morphology were evaluated at necropsy and vaginal cytology during the week preceding necropsy. Male and female gonadal weights were also determined with gross pathology and histopathology of reproductive organs at termination. - GLP compliance:
- yes
- Remarks:
- FDA Good Laboratory Practices Regulations (21 CFR 58)
- Limit test:
- no
Test material
- Reference substance name:
- Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy
- IUPAC Name:
- Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy
- Details on test material:
- - Name of test material (as cited in study report): Castor oil (CAS N° 8001-79-4, EC N° 232-293-8). Under the SDA nomenclature, the name of this substance is ‘Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy'
- Physical state: Liquid
- Analytical purity: Purity and identity analyses were conducted by Midwest Research Institute (MRI) (Kansas City, MO)
- Analytical method used: Karl Fischer water analysis, thin layer and high performance liquid chromatography, and a battery of U.S. Pharmacopeia (USP) standard analyses for castor oil
- Lot/batch No.: #L-5G30-01
- Other: Source: Cas Chemical, Inc.
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 wk
- Fasting period before study: No
- Housing: 5 per cage in polycarbonate cages lined with heat-treated hardwood chips and covered with polyester filter sheets. The cages were stored on stainless steel racks equipped with an automatic watering system
- Diet: NIH 07; available ad libitum
- Water: Ad libitum
- Acclimation period: 14 d
- Other: Feed hoppers in the animal cages were changed twice weekly
ENVIRONMENTAL CONDITIONS
- Temperature: 68-76 °F
- Humidity: 42-72%
- Air changes: 10 room air changes/h
- Photoperiod: 12 h dark/12 h light
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- Method of mixing: 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 amounts of feed in a twin-shell blender and blended for 15 minutes to achieve a uniform mix.
- Storage temperature of food: Stored for no longer than 3 weeks at 5 °C
- Stability under test conditions: 0.5% dose level is 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. - Details on mating procedure:
- No mating performed
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Determined by HPLC at the study and analytical chemistry laboratories in duplicates. 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 wk or 90 d
- Frequency of treatment:
- Daily
- Details on study schedule:
- None
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.62, 1.25, 2.5, 5.0 or 10% in diet
Basis:
actual ingested
- No. of animals per sex per dose:
- 10 rats per sex per dose
- Control animals:
- yes, plain diet
- Details on study design:
- None
- Positive control:
- Not applicable
Examinations
- Parental animals: Observations and examinations:
- All routine examinations were performed including body weight, food consumption, hematology and clinical chemistry. For details see section 7.5.1: Repeated dose toxicity-oral; Endpoint study record: Castor oil (232-293-8), Repeated dose toxicity: oral (rats), KL2, Irwin, 1992.
- Oestrous cyclicity (parental animals):
- Yes (at 12 wk)
- Sperm parameters (parental animals):
- Testis weight, epididymis weight, sperm count, motility and morphology were evaluated at necropsy (termination of study)
- Litter observations:
- Not examined
- Postmortem examinations (parental animals):
- Following reproductive organs were examined grossly and histologically apart from routine examinations:
Epididymis/seminal vesicles/prostate/testes or ovaries/uterus
- Complete histopathology examinations were conducted on all rats from the control and 10% dose groups - Postmortem examinations (offspring):
- Not examined
- Statistics:
- Statistically analyzed within each sex by one-way Analysis of Variance tests, followed by Dunnett's t-test for pair-wise comparisons (p < 0.05)
- Reproductive indices:
- No data
- Offspring viability indices:
- Not calculated
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- 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:
- not examined
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEC
- Effect level:
- > 10 other: % in diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on male and female reproductive screening parameters
Target system / organ toxicity (P0)
- 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
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Details on results (F1)
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the reproductive screening NOAEL of castor oil to rat was estimated to correspond to 10% in diet (i.e. ca. 5800 mg/kg bw/day based on actual feed consumption and body weight data).
- Executive summary:
A 90 d oral repeated dose study was conducted in F344/N rat to evaluate the sub-chronic toxicity of castor oil in which reproductive parameters were also screened.
Rats (10 /sex / group) were exposed for 13 weeks to 0, 0.62, 1.25, 2.5, 5.0 or 10% castor oil mixed in diet. Apart from the standard sub-chronic toxicity examinations, sperm count, motility and morphology were evaluated at necropsy and vaginal cytology during the week preceding necropsy. Male and female gonadal weights were also determined with gross pathology and histopathology of reproductive organs at termination.
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 female estrous cycles. No significant changes were noted in male and female gonadal organs at necropsy except there was a slight decrease in epididymal weight (6-7%) which occurred in the middle- and high-dose groups, but this was not dose-related.
Under the conditions of this study, the reproductive screening NOAEL of castor oil to rat was estimated to correspond to 10% in diet (i.e. ca. 5800 mg/kg bw/day based on actual feed consumption and body weight data).
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