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EC number: 274-635-9 | CAS number: 70514-12-4
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because it an acceptable well-documented study report that followed sound scientific principles.
Data source
Materials and methods
- Objective of study:
- metabolism
- Principles of method if other than guideline:
- The method did not strictly follow the guideline but is deemed appropriate as utilized in this report.
- GLP compliance:
- not specified
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: six to eight weeks
- Housing: individually caged
- Diet (e.g. ad libitum): laboratory rat diet LAD2 (special diet services, Witham, Essex) was offered ad libitum
- Water (e.g. ad libitum): offered ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: "DISTOL"-grade hexane
- Details on exposure:
- The test oils were separately incorporated into powdered laboratory rat diet, LAD2 at concentrations ranging from 10 to 20,000 ppm. Each oil was first dissolved in solvent ("DISTOL"-grade hexane) and a premix was used to achieve homogeneous dispersal in each batch of final test diet. An equivalent volume of solvent was also mixed with control diet.
- Duration and frequency of treatment / exposure:
- Animals were fed diet with test material for 13 weeks. Mean daily intake of food was calculated.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Experiment 1, Oleum-treated white oil (OTWO): 5000, 10,000, 20,000 ppm
Experiment 2, OTWO: 10, 100, 500, 1000, 10,000, 20,000 ppm
Experiment 1, Hydrotreated white oil (HTWO): 5000, 10,000, 20,000 ppm
Experiment 2, HTWO: 10, 100, 500, 5000, 10000, 20000 ppm
- No. of animals per sex per dose / concentration:
- Experiment 1 (OTWO and HTWO): three males and three females
Experiment 2 (OTWO and HTWO): six females - Control animals:
- no
- Details on dosing and sampling:
- METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled : cardiac blood was collected at terminal necropsy and tail vein blood was taken 7 days prior to necropsy. Haematological variants were monitored and analyzed by autoanalyzer - Statistics:
- Statistical analysis of data was accomplished by analysis of variance with a modified Student's t-test procedure for food intake, clinical chemistry, and haematological variants. The Wilcoxon two-sample rank sum test and Fisher's exact test were also used.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- There were no mortalities and no adverse clinical signs associated with feeding either white oil. Treatment-related effects evidenced by heematological, clinical chemical, and pathological changes were generally dose-related and more marked in female than in male rats, and the OTWO caused a greater pathological response than the HTWO. Tissue residues of saturated hydrocarbons were up to 5.2 times higher in female rats than in males. Rats fed 5,000 ppm or more of either white oil showed dose-related alterations in several haematological and clinical chemistry variates associated mainly with hepatic damage or functional alteration. At necropsy, mesenteric lymph nodes were enlarged, and increases in weight of liver, kidney, and spleen were significant. Microscopic changes were characterized by multifocal lipogranulomata in mesenteric lymph node and liver. No changes were observed in rats fed OTWO or HTWO for 90 days at dietary concentrations of 10 or 100 ppm, equivalent to a minimum intake of 0.65 and 6.4 mg/kg/day, respectively. Differences in degree of pathological response associated with each oil may have been due to their differences in specification rather than processing method.
Any other information on results incl. tables
C16 and C18 hydrocarbons that are constituents of lubricant base oils are metabolised to corresponding fatty acids of the same carbon chain length as the parent hydrocarbons, suggesting a process of omega oxidation.
There were no deaths or any clinical signs caused by feeding either OTWO or HTWO at dietary concentrations up to the maximum of 20000 ppm. The only effect noted was a mild increase in food intake of males fed 20000 ppm OTWO during weeks 3 through 6 of the study. The only haematological changes attributes to treatment were slight leukocytosis and granulocytosis in rats of both sexes fed 20000 ppm of either white oil, with slight hypochromic microcytic anaemia in the 20000 ppm OTWO-fed females. Clinical chemistry findings in rats fed 5,000 ppm or more of either white oil indicated slight hepatic damage and functional disturbance. At necropsy, treatment-related organ weight changes occurred in mesenteric lymph node, spleen, liver, and kidney. Analysis of liver and mesenteric lymph node for total hydrocarbon residues showed higher tissue concentrations in females than in males. In both liver and mesenteric lymph node of treated rats, total hydrocarbon concentrations were greater in OTWO-fed rats than in HTWO-fed rats. There were no treatment-related histological changes in mesenteric lymph node or liver of rats fed 500 or 10,000 ppm of either white oil for 25 days. After 90 days lesions were found in mesenteric lymph node, liver, and spleen. Across all analyses (haematology, clinical chemistry, gross necropsy, tissue residue, and histopathology) findings were more marked in in female rats and male or female rats fed OTWO
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the pathological findings in the test animals were quantitatively similar to those previously associated with the ingestion of mineral hydrocarbons by a range of species, but the effects occurred at much lower levels of dietary intake than previously reported. No pathological changes were observed after 25 days of feeding, but after 90 days there were very slight to moderate multifocal granulomatous changes in mesenteric lymph nodes and liver. Although rats fed the OTWO were more affected than those fed the HTWO differences in the specification of each oil rather than processing method were more likely to have accounted for the variation. The insufficiently refined hydrocarbons (oleum-treated white oil) are suggested to undergo a process of omega oxidation. The sufficiently refined hydrocarbons (hydrotreated white oil) are metabolized to the corresponding fatty acids of the same carbon chain length as the parent carbons, suggesting omega oxidation.
- Executive summary:
Read across justification
In this study highly refined mineral oils (White oils) were tested, but being similar in composition to lubricant base oils, similar toxicokinetic properties would be expected.
In a basic toxicokinetics study, a group of male and female rats were fed oleum-treated white oil (OTWO) and hydrotreated white oil (HTWO) in concentrations of 5000, 10000, 20000 ppm and a group of female rats were fed OTWO and HTWO in concentrations of 10, 100, 500, 1000, 10000, 20000 ppm for a period of 13 weeks. Animals were euthanized at the conclusions of the study, after which haematological, clinical chemistry, gross necropsy, tissue residue, and histopathological examination were preformed.
Pathological findings in the test animals were quantitatively similar to those previously associated with the ingestion of mineral hydrocarbons by a range of species, but the effects occurred at much lower levels of dietary intake than previously reported. No pathological changes were observed after 25 days of feeding, but after 90 days there were very slight to moderate multifocal granulomatous changes in mesenteric lymph nodes and liver. Although rats fed the OTWO were more affected than those fed the HTWO differences in the specification of each oil rather than processing method were more likely to have accounted for the variation. The insufficiently refined hydrocarbons (oleum-treated white oil) are suggested to undergo a process of omega oxidation. The sufficiently refined hydrocarbons (hydrotreated white oil) are metabolized to the corresponding fatty acids of the same carbon chain length as the parent carbons, suggesting omega oxidation.
This study received a Klimisch score of 2 and is classified as reliable with restrictions.
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