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EC number: 939-894-0 | CAS number: -
- 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
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study is not required at this level of registration. However, it is included as it provides useful supporting information to the repeated dose studies listed above. This literature paper is classified as K2, reliable with restrictions as it was conducted to a recognised guideline on a known structural analogue, and is a well documented report.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Groups of 50 Fischer 344 rats of each sex were fed diets containing white oil at dietary concentrations of 0, 2.5 or 5%. Body weights and food intakes were recorded throughout the study and after 104 weeks surviving animals were killed.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data reported.
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Groups of 50 Fischer 344 rats of each sex were fed diets containing white oil at dietary concentrations of 0, 2.5 or 5% for 104 weeks. Dose concentrations are listed below.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available.
- Duration of treatment / exposure:
- 104 weeks,
- Frequency of treatment:
- Daily in feed.
- Post exposure period:
- None; test subjects were terminated at the completion of the study.
- Remarks:
- Doses / Concentrations:962.2 or 1941.9 mg/kg/day for males, 1135.4 or 2291.5 mg/kg/day for females (2.5 and 5.0%) Basis:nominal in diet
- No. of animals per sex per dose:
- 50
- Control animals:
- yes
- Details on study design:
- Groups of 50 Fischer 344 rats of each sex were fed diets containing white oil at dietary concentrations of 0, 2.5 or 5%. Body weights and food intakes were recorded throughout the study and after 104 weeks surviving animals were killed. Blood samples were collected for haematological and clinical chemical determinations and a full necropsy was performed on all animals. Organ weights were recorded and a histopathological examination was undertaken on major organs, all tumours and masses.
- Positive control:
- No
- Observations and examinations performed and frequency:
- No specific data.
- Sacrifice and pathology:
- Blood samples were collected for haematological and clinical chemical determinations and a full necropsy was performed on all animals. Organ weights were recorded and a histopathological examination was undertaken on major organs, all tumours and masses.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- 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:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- There were slight increases in body weights in both sexes of the 5% group (5% for males and 2.7% for females) at week 104. Food consumption was also increased in the 5% groups (11% for males and 8% for females total increase at week 104). However, no significant treatment-related differences between the control and treated groups were observed for clinical signs, mortality or hematological findings. In the 5% group, absolute liver and kidney weights were increased in males and absolute and relative submaxillary gland weights were reduced in females.
- Relevance of carcinogenic effects / potential:
- Non-carcinogenic.
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 941.9 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: equivalent to ≥ 5% of daily diet
- Remarks on result:
- other: Effect type: carcinogenicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 2 291.5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: equivalent to ≥ 5% of daily diet
- Remarks on result:
- other: Effect type: carcinogenicity
- Conclusions:
- A variety of tumors developed in all groups, including the control group. However, all the neoplastic lesions were histologically similar to those known to occur spontaneously in F344 rats, and no statistically significant increase in the incidence of any tumor type was found for either sex in the treated groups. Granulomatous inflammation in the mesenteric lymph nodes, considered to be a reaction to paraffin absorption, was observed with similar incidence and severity in both sexes of the 2.5 and 5% groups. The authors concluded that under the present experimental conditions, the high dose, about 2000-200,000 times higher than the current temporary acceptable daily intake, did not have any carcinogenic potential in F344 rats. Furthermore, the granulomatous inflammation observed in the mesenteric lymph nodes was not associated with any development of neoplastic lesions.
- Executive summary:
A full justification for the read across applied for this substance is contained within Section 1.4, reference " Explanation of NovaSpec Base Oil - FINAL". This document contains a full explanation of the manufacturing route for the substance and discussion on why this substance should be considered as a UVCB white oil analogous to CAS 8042-47-5. Physical properties of the crude reaction product and the different product grades (or distillate fractions) derive from the general chemical structure characteristics (linear-branched alkanes with characteristic branching length and position). Specific unique chemical structures are not isolated in any process step and due to the tens of thousands of isomers and the high degree and variable nature branching and chain length, the base oil bulk properties are the result of the average structure characteristics. The unique viscosity grades each contain all the same typical chemical structures and predominantly overlapping Molecular Weight distributions. The unique viscosity and volatility characteristics of each viscosity grade derive from the boiling point distribution, a result of the short-path distillation (wiped film evaporation). This is identical to the production of petroleum derived white oils.
Within the test, a variety of tumors developed in all groups, including the control group. However, all the neoplastic lesions were histologically similar to those known to occur spontaneously in F344 rats, and no statistically significant increase in the incidence of any tumor type was found for either sex in the treated groups. Granulomatous inflammation in the mesenteric lymph nodes, considered to be a reaction to paraffin absorption, was observed with similar incidence and severity in both sexes of the 2.5 and 5% groups. The authors concluded that under the experimental conditions, the high dose, about 2000-200,000 times higher than the current temporary acceptable daily intake, did not have any carcinogenic potential in F344 rats. Furthermore, the granulomatous inflammation observed in the mesenteric lymph nodes was not associated with any development of neoplastic lesions, and were considered to be a species specific effect. This is discussed above under “repeated dose toxicity”.
No classification is applicable.
Reference
Absolute and relative weights of heart and spleen were unaffected by treatment. The percentage increases/decreases in the 5% group were:
Organ |
Absolute |
Relative |
Female |
||
Submaxillary gland |
3% decrease |
1.7% decrease |
Male |
||
Liver |
8.4% increase |
not different |
Kidney (R) |
14.9% increase |
not different |
Kidney (L) |
9.9% increase |
not different |
In the 5% male group, the increased absolute organ weights were attributed to the slight increases in body weights.
A variety of tumors developed in all groups, including the control group. However, all the neoplastic lesions were histologically similar to those known to occur spontaneously in F344 rats, and no statistically significant increase in the incidence of any tumor type was found for either sex in the treated groups. Granulomatous inflammation in the mesenteric lymph nodes, considered to be a reaction to paraffin absorption, was observed with similar incidence and severity in both sexes of the 2.5 and 5% groups. The authors concluded that under the present experimental conditions, the high dose, about 2000-200,000 times higher than the current temporary acceptable daily intake, did not have any carcinogenic potential in F344 rats. Furthermore, the granulomatous inflammation observed in the mesenteric lymph nodes was not associated with any development of neoplastic lesions.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 941.9 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
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
Within the test, a variety of tumors developed in all groups, including the control group. However, all the neoplastic lesions were histologically similar to those known to occur spontaneously in F344 rats, and no statistically significant increase in the incidence of any tumor type was found for either sex in the treated groups. Granulomatous inflammation in the mesenteric lymph nodes, considered to be a reaction to paraffin absorption, was observed with similar incidence and severity in both sexes of the 2.5 and 5% groups. The authors concluded that under the experimental conditions, the high dose, about 2000-200,000 times higher than the current temporary acceptable daily intake, did not have any carcinogenic potential in F344 rats. Furthermore, the granulomatous inflammation observed in the mesenteric lymph nodes was not associated with any development of neoplastic lesions, and were considered to be a species specific effect. This is discussed above under “repeated dose toxicity”.
No classification is applicable.
Additional information
A full justification for the read across applied for this substance is contained within Section 1.4, reference " Explanation of NovaSpec Base Oil - FINAL". This document contains a full explanation of the manufacturing route for the substance and discussion on why this substance should be considered as a UVCB white oil analogous to CAS 8042-47-5. Physical properties of the crude reaction product and the different product grades (or distillate fractions) derive from the general chemical structure characteristics (linear-branched alkanes with characteristic branching length and position). Specific unique chemical structures are not isolated in any process step and due to the tens of thousands of isomers and the high degree and variable nature branching and chain length, the base oil bulk properties are the result of the average structure characteristics. The unique viscosity grades each contain all the same typical chemical structures and predominantly overlapping Molecular Weight distributions. The unique viscosity and volatility characteristics of each viscosity grade derive from the boiling point distribution, a result of the short-path distillation (wiped film evaporation). This is identical to the production of petroleum derived white oils.
Within the test, a variety of tumors developed in all groups, including the control group. However, all the neoplastic lesions were histologically similar to those known to occur spontaneously in F344 rats, and no statistically significant increase in the incidence of any tumor type was found for either sex in the treated groups. Granulomatous inflammation in the mesenteric lymph nodes, considered to be a reaction to paraffin absorption, was observed with similar incidence and severity in both sexes of the 2.5 and 5% groups. The authors concluded that under the experimental conditions, the high dose, about 2000-200,000 times higher than the current temporary acceptable daily intake, did not have any carcinogenic potential in F344 rats. Furthermore, the granulomatous inflammation observed in the mesenteric lymph nodes was not associated with any development of neoplastic lesions, and were considered to be a species specific effect. This is discussed above under “repeated dose toxicity”.
Justification for selection of carcinogenicity via oral route endpoint:
Available literature study paper
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