Registration Dossier
Registration Dossier
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EC number: 264-705-7 | CAS number: 64147-40-6
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
