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EC number: 204-010-8 | CAS number: 112-85-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 17 Mar - 16 June 1969
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Rats were fed a diet containing 5, 10 and 25% oleic acid over a time period of 84 days.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Oleic acid
- EC Number:
- 204-007-1
- EC Name:
- Oleic acid
- Cas Number:
- 112-80-1
- Molecular formula:
- C18H34O2
- IUPAC Name:
- octadec-9-enoic acid
1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 115-116 g
- Housing: individually in wire bottomed steel cages, animals were also ear punched
- Diet (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): standard rat ration
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 84 days
- Frequency of treatment:
- no data
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 other: % nominal in diet
- Remarks:
- corresponding to 2500 mg/kg bw/day (calculated based on the average daily food consumption of 5 g/100 g bw (WHO, 1987))
- Dose / conc.:
- 10 other: % nominal in diet
- Remarks:
- corresponding to 5000 mg/kg bw/day (calculated based on the average daily food consumption of 5 g/100 g bw (WHO, 1987))
- Dose / conc.:
- 25 other: % nominal in diet
- Remarks:
- corresponding to 12500 mg/kg bw/day (calculated based on the average daily food consumption of 5 g/100 g bw (WHO, 1987))
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations: abnormal reactions and mortality
BODY WEIGHT: Yes
- Time schedule for examinations: weekly for five rats of each sex of each group
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined: collected weekly for five rats of each sex in all groups
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at day 84 of feeding
- How many animals: five rats of each sex in the control and 25% dosage group and three rats of each sex in the 10% group
- Parameters checked: hematocrit, hemaglobin concentration, erythrocyte count, total and differential leukocyte count, reticulocyte count, prothrombin time and cell index (MCV, MCH, MCHC)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at day 84 of feeding
- How many animals: five rats of each sex in the control and 25% dosage group and three rats of each sex in the 10% group
- Parameters checked: fasted serum glucose, total cholesterol, blood urea nitrogen, total protein, serum alkaline phosphatase (SAP), serum glutamic-pyruvic transaminase (SGPT), serum glutamic-oxalacetic tranaminase (SGOT), A/G ratio and Icterus index
URINALYSIS: Yes
- Time schedule for collection of urine: at day 84 of feeding
- Parameters checked: protein, glucose, pH, specific gravity and microscopic elements
NEUROBEHAVIOURAL EXAMINATION: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, all animals that died during the study were examined grossly unless examination was precluded by post-mortem autolysis. At the end of the 90-day feeding period, all surviving rats were necropsied, and organ weights were recorded for liver, kidneys, spleen, gonads, adrenals, heart, thymus and brain.
HISTOPATHOLOGY: Yes, histopathological examinations were conducted on: brain, spinal cord, pituitary, thyroid, parathyroid, thymus, salivary glands, stomach, small and large intestines, liver, pancreas, kidneys, adrenals, spleen, heart, trachea, lungs, aorta, testes, seminal vesicle, ovary, uterus, prostate, urinary bladder, lymph nodes, peripheral nerve, bone marrow, skeletal muscle, bone (femur), eye and optic nerve. - Statistics:
- Organ and body weights were analyzed using analysis of variance and a t-test.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 3 animals died due to blood collection trauma
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 3 animals died due to blood collection trauma
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- slightly higher final body weights in treatment groups, not statistically significant
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- slightly decreased in treatment groups, non-adverse
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- significant differences in organ/body weight ratios except for kidneys, adrenal glands and brain, non-adverse
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Two control animals died on day 84. These deaths were related to blood collection. One female animal from the 10% dosage group also died from blood collection trauma. There were no other mortalities or clinical signs of toxicity.
BODY WEIGHT AND WEIGHT GAIN
The test animals had slightly higher final body weights than controls, but the differences were not statistically significant.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Food consumption among test animals was slightly lower than among the control animals.
HAEMATOLOGY
There were no outstanding differences in hematologic parameters among test and control animals
CLINICAL CHEMISTRY
There were no outstanding differences in clinical chemistry parameters among test and control animals
URINALYSIS
There were no outstanding differences in urinalysis parameters among test and control animals
NEUROBEHAVIOUR
No abnormal behavioural reactions were noted in the study.
ORGAN WEIGHTS
There were no significant differences in organ/body weight ratios except for kidneys, adrenal glands and brain. For these three organs, female test animals showed a higher organ/body weight ratio than control animals. All of these differences could be attributed to the slightly higher body weights observed in every test group rather than a deleterious effect of the test material. The absence of any abnormalities of these organs upon histopathologic examination would support this conclusion.
GROSS PATHOLOGY
No abnormalities were noted at gross examination.
HISTOPATHOLOGY: NON-NEOPLASTIC
Some minor histopathologic changes were noted among both the test and control animals, specifcially involving lesions in the trachea and lungs. These changes were judged to be due to spontaneous disease (potential pneumonia), and not related to the test material.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 25 other: % (nominal in diet)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: NOAEL corresponding to the highest dose tested
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 12 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: NOAEL corresponding to the highest dose tested
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Oleic acid is practically nontoxic to rats in a repeated dose study when given doses of up to 25% in the diet. The NOAEL was ≥25% equivalent to ≥12500 mg/kg bw/day.
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