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EC number: 265-228-7 | CAS number: 64755-01-7
- 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
Carcinogenicity
Administrative data
Description of key information
The 2-year oral carcinogenic study in rats with sodium oleate administered in the drinking water (no guideline specified) gave a NOAEL of 5% sodium oleate in the water, the maximum concentration administered. No evidence of increased incidence of tumours was observed following treatment. On the basis of the long history of safe use of fatty acid soaps in greases, the substances in the category are not considered to be carcinogens.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP status not known, guideline study, published in a regulatory document. Only summary of study is available, limitations in design and/or reporting but otherwise adequate for assessment.
- Principles of method if other than guideline:
- - Method: 2.5 and 5.0 % sodium oleate in drinking water was administered orally to 50 male and 50 female rats for 108 weeks.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age: 7 weeks at test initiation
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- - Dose concentration: 2.5 and 5.0 % in drinking water
- Control: Distilled water only - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data reported
- Duration of treatment / exposure:
- - Duration of exposure: 108 weeks
- Frequency of treatment:
- No data reported
- Post exposure period:
- No data reported
- Remarks:
- Doses / Concentrations:
2.5 %
Basis:
nominal in water - Remarks:
- Doses / Concentrations:
5.0 %
Basis:
nominal in water - No. of animals per sex per dose:
- - Number of animals: 50 male and 50 female
- Control animals:
- yes, plain diet
- Details on study design:
- No data reported
- Positive control:
- No data reported
- Observations and examinations performed and frequency:
- No data reported
- Sacrifice and pathology:
- No data reported
- Other examinations:
- No data reported
- Statistics:
- No data reported
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Bodyweight gain was slightly reduced in males but not in females.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Water consumption was slightly depressed in females but not in males.
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- A slight depression in the serum bilirubin of males in the 5.0 % treatment group was the only statistically significant finding (p<0.05) in the serum and urine analyses and in the haematological determinations of treated and control groups.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- A slight depression in the serum bilirubin of males in the 5.0 % treatment group was the only statistically significant finding (p<0.05) in the serum and urine analyses and in the haematological determinations of treated and control groups.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- A slight depression in the serum bilirubin of males in the 5.0 % treatment group was the only statistically significant finding (p<0.05) in the serum and urine analyses and in the haematological determinations of treated and control groups.
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- In the 5 % treatment group, the mean weights of the liver of males and of the heart, pancreas and adrenals of females were significantly lower (p<0.05) than the respective controls, while the weight of the thymus in the females was significantly higher.
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- Tumours developed in various organs but there was no significant difference between their incidence in oleate-treated and control rats.
- Details on results:
- - Pancreatic tumours: A significant difference between the incidence in oleate-treated and control rats of pancreatic tumors was observed (0 % - 0/41 M, 1/43 F; 2.5 % - 4/40 M, 1/39 F; 5 % - 7/45 M, 1/45 F). However, there was an unusual absence of pancreatictumors in the control rats and the incidence of pancreatic tumors in the treated rats was considered to be within the normal background level for this strain of rat.
- Relevance of carcinogenic effects / potential:
- The weight of evidence approach, including consideration of the historical range of pancreatic tumors, indicates that sodium oleate orally administered to rats does not induce tumors.
- Dose descriptor:
- NOEL
- Effect level:
- 5 other: % in drinking water
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The weight of evidence approach, including consideration of the historical range of pancreatic tumours, indicates that sodium oleate orally administered to rats does not induce tumours.
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- Under the test conditions, the carcinogencity NOEL for sodium oleate in rats is 5 % in drinking water.
- Executive summary:
The weight of evidence approach, including consideration of the historical range of pancreatic tumors, indicates that sodium oleate orally administered to rats does not induce tumors. Under the test conditions, the carcinogencity NOEL for sodium oleate in rats is 5 % in drinking water. The carcinogenicity to rats was determined in a two year oral study (Hiasa et al. 1985) in which 50 male and 50 female rats were given 2.5 % and 5.0 % sodium oleate in drinking water for 108 weeks. Only a summary of the study is available but the information is taken from a peer reviewed article and can be considered adequate for use for this endpoint.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Limited. The study is taken from a review documents (HERA 2002) citing a published test. No guideline was stated but a standard procedure was used. The data are considered reliable and suitable for use for this endpoint since they are peer-reviewed prior to publication.
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Not classified for carcinogenicity. No treatment-related increase in tumour incidence
Additional information
The substances in the category are considered to be similar on the basis that they have common structures of a calcium ion varying only by the length of the fatty acid chain and the presence of unsaturated and/or hydroxyl functional groups. As a result it is expected that the substances will have similar, predictable properties. REACH Annex V, Entry 9, groups fatty acids and their potassium, sodium, calcium and magnesium salts, including C6 to C24, predominantly even-numbered, unbranched, saturated or unsaturated aliphatic monocarboxylic acids. Provided that they are obtained from natural sources and are not chemically modified, the substances included in REACH Annex V, Entry 9 are exempt from registration, unless they are classified as dangerous (except for flammability, skin irritation or eye irritation) or they meet the criteria for PBT/vPvB substances. The metal fatty acid substances in the category are therefore not expected to be hazardous. Due to the close structural similarity and the narrow range of carbon chain numbers covered in this category, the carcinogenicity properties are expected to be predictable across the category.
Since REACH Annex V groups together calcium, potassium, sodium and magnesium salts of C6 to C24 fatty acids as being potentially exempt from registration, these metal cations are therefore not considered to contribute to any health hazard. On this basis, relevant published or proprietary data on any potassium, sodium or magnesium salt within the fatty acid category range of C14 to C22 can be used to read across to the calcium salts of C14-C22 fatty acid category.
Fats and oils are commonly used as controls and vehicle diluents/solvents in long term toxicity studies, e.g. corn (mazola) oil. On this basis they are considered not to possess carcinogenic activity.
A two-year carcinogenicity study in rats with sodium oleate (C18 unsaturated) administered in drinking water showed no significant difference between the incidence of tumours between the treated and control groups, and it was concluded that this substance did not exhibit tumourigenic potential in rats under the conditions of the test.
On the basis of long history of safe use of fatty acid soaps in greases, the substances in the category are not considered to be carcinogens.
Justification for selection of carcinogenicity via oral route endpoint:
A valid carcinogenicity study on sodium oleate (C18) that is relevant to the calcium salts of C14-C22 fatty acids and the results can be read across to the category members.
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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