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EC number: 264-705-7 | CAS number: 64147-40-6
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive toxicity data is available for substances representative of castor oil, dehydrated.
Effects on fertility
Castor oil administered at up to 10% in diet to rats for 13 weeks according to OECD Guideline 408 showed no significant changes in male reproductive endpoints, including sperm count and motility, and no changes in length of female estrous cycles at the highest dose tested. The NOAEL for this study was determined to be 10% in diet, i.e. ca. 5,800 mg/kg bw/day) (Irwin, 1992).
In a repeated dose/developmental screening test and a multi-generation study via diet in rat with palm/soybean oil and palm oil (C16-18 and C18-unsatd.), respectively, no significant effects on fertility parameters were seen at the highest doses tested. The NOAELs were established at 15% in diet (i.e. from 17,000 to 7,000 mg/kg bw/day, as the bodyweight of animals increased regularly over the course of the study) for palm/soybean oil (Coquet et al., 1977) and 10% in diet (i.e. ca. 5,000 mg/kg bw/day) for palm oil (Manorama et al., 1993).
Palm kernel oil (C8-18 and C18-unsatd.) yielded a NOAEL for the F2 generation of 8.75% in diet (i.e. ca. 4,375 mg/kg bw/day) based on no effects on frequency of litters, mean litter size, total number of newborns and no suckling death in a 2-generation study in gerbil (Temmerman et al.,1988).
Developmental toxicity
The developmental toxicity of partially hydrogenated soybean oil (C16-18 and C18-unsatd.) was evaluated in rat at a dose of 15% in feed during a 2-generation study. The NOAEL formaternal toxicity was 15% in diet (i.e. ca. 7,500 mg/kg bw/day) based on no effects on growth and food consumption, gross pathology, organ weights, histopathology, average conception rate, number of corpora lutea, implantations and resorptions. The NOAEL for developmental toxicity was at the same dose, given no effects on sizes of litters at birth, stillbirths, live births, postnatal mortality, weight gain; skeletal variations/defects and soft-tissue abnormalities (Nolen, 1972).
Adducts formed by glycerides similar to those tested above are not expected to have a different a reproductive toxicity profile compared to individual glycerides.
Based on available data, castor oil, dehydrated is not likely to be toxic to reproduction.
Justification for selection of Effect on fertility via oral route:
No one study was selected since all the studies contribute to the endpoint conclusion.
Justification for selection of Effect on fertility via inhalation route:
No one study was selected since all studies contribute to the endpoint conclusion.
Justification for selection of Effect on fertility via dermal route:
No one study was selected since all studies contribute to the endpoint conclusion.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive toxicity data is available for substances representative of castor oil, dehydrated.
Effects on fertility
Castor oil administered at up to 10% in diet to rats for 13 weeks according to OECD Guideline 408 showed nosignificant changes in male reproductive endpoints, including sperm count and motility, and no changes in length of female estrous cycles at the highest dose tested. The NOAEL for this study was determined to be 10% in diet, i.e. ca. 5,800 mg/kg bw/day) (Irwin, 1992).
In a repeated dose/developmental screening test and a multi-generation study via diet in rat with palm/soybean oil and palm oil (C16-18 and C18-unsatd.), respectively, no significant effects on fertility parameters were seen at the highest doses tested. The NOAELs were established at 15% in diet (i.e. from 17,000 to 7,000 mg/kg bw/day, as the bodyweight of animals increased regularly over the course of the study) for palm/soybean oil (Coquetet al., 1977) and 10% in diet (i.e. ca. 5,000 mg/kg bw/day) for palm oil (Manoramaet al., 1993).
Palm kernel oil (C8-18 and C18-unsatd.) yielded a NOAEL for the F2 generation of 8.75% in diet (i.e. ca. 4,375 mg/kg bw/day) based on no effects onfrequency of litters, mean litter size, total number of newborns and no suckling death in a 2-generation study in gerbil (Temmermanet al.,1988).
Developmental toxicity
The developmental toxicity of partially hydrogenated soybean oil (C16-18 and C18-unsatd.) was evaluated in rat at a dose of 15% in feed during a 2-generation study. The NOAEL formaternal toxicity was 15% in diet (i.e. ca. 7,500 mg/kg bw/day) based on no effects on growth and food consumption, gross pathology, organ weights, histopathology, average conception rate, number ofcorpora lutea, implantations and resorptions. The NOAEL for developmental toxicity was at the same dose, given no effects on sizes of litters at birth, stillbirths, live births, postnatal mortality, weight gain; skeletal variations/defects and soft-tissue abnormalities (Nolen, 1972).
Adducts formed by glycerides similar to those tested above are not expected to have a different a reproductive toxicity profile compared to individual glycerides.
Based on available data, castor oil, dehydrated is not likely to be toxic to reproduction.
Justification for selection of Effect on developmental toxicity: via oral route:
No one study was selected since all studies contribute to the endpoint conclusion.
Justification for selection of Effect on developmental toxicity: via inhalation route:
No one study was selected since all studies contribute to the endpoint conclusion.
Justification for selection of Effect on developmental toxicity: via dermal route:
No one study was selected since all studies contribute to the endpoint conclusion.
Justification for classification or non-classification
Based on the above information, castor oil, dehydrated does not qualify for reproductive or developmental effects classification according to Directive 67/548/EC or Regulation 1272/2008/EC.
Additional information
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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