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EC number: 232-455-8 | CAS number: 8042-47-5 A highly refined petroleum mineral oil consisting of a complex combination of hydrocarbons obtained from the intensive treatment of a petroleum fraction with sulfuric acid and oleum, or by hydrogenation, or by a combination of hydrogenation and acid treatment. Additional washing and treating steps may be included in the processing operation. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C50.
- 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
Endpoint summary
Administrative data
Description of key information
Highly refined base oils are of low acute toxicity in animal studies conducted by oral (similar to OECD 401), dermal (similar to OECD 402), and inhalation (similar to OECD 403) exposure.
• The oral LD50 was > 5000 mg/kg bw in male and female rats for highly refined base oils.
• The inhalation LC50 was > 5 mg/L (5000 mg/m3) aerosol in male and female rats for highly refined base oils.
• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for highly refined base oils.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 000 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute Oral
In a key acute oral toxicity study, Sprague-Dawley rats (5/sex) were administered a single oral gavage dose of 5000 mg/kg of highly refined base oil (Klimisch score = 2, ARCO, 1987b). After 14 days no mortality was observed. One of ten animals exhibited loose stools on the day of dosing. No gross lesions were present at necropsy. All animals exhibited an overall net weight gain over the study period. The acute oral LD50 of white mineral oil is greater than 5000 mg/kg body weight and not classified according to EU guidelines.
In a supporting study conducted on highly refined base oil (Klimisch score = 2; ARCO, 1987a), rats were administered a single oral gavage dose of 5000 mg/kg bw. No mortality or other systemic effects were noted at this dose level.
Acute Inhalation
For acute inhalation the key study analyzed the effects of white mineral oil on male and female Crl:CD(SD)BR rats exposed (whole body) to 5 mg/L of aerosolized highly refined base oil for 4 hours (Klimisch score = 1, ARCO 1988a). After 14 days no mortality was observed. Clinical signs included laboured breathing, rates, partial closing of the eyes, nasal discharge, recumbency, and incoordination. All animals appeared normal at day 5 after exposure and throughout the remainder of the study period. Four of five females had transient weight loss during the first week of observation. The LC50 of highly refined base oil aerosol administered to rats is greater than 5 mg/L (5000 mg/m3). This dose level is not classified according to EU guidelines.
In a supporting study, rats were exposed via inhalation to highly refined base oil. The LC50 as measured based on mortality and systemic effects was > 4.5 mg/L aerosol (Klimisch score = 1, ARCO 1988b). In an additional supporting study, rats were exposed to 5.2 mg/L aerosol of highly refined base oil (Klimisch score = 1, MB Research Laboratories, Inc., 1997). Based on mortality and systemic effects, the LC50 was > 5.2 mg/L. These results do not lead to classification of highly refined base oils as acute inhalation toxicants.
Acute Dermal
A key study analyzed the acute dermal toxic effects of highly refined base oil at a dose of 2000 mg/kg under semi-occlusive conditions for 24 hours (Klimisch score = 2, ARCO, 1987c). After 14 days of exposure no mortality or treatment-related lesions were observed. Three animals lost weight on week two and one animal lost weight during the 14-day observation period. No gross lesions were observed upon necropsy. The acute dermal toxicity LD50 of highly refined base oil to male and female New Zealand White Rabbits is greater than 2000 mg/kg and, therefore, is not classified under EU guidelines.
In a supporting study, rabbits were dermally exposed to 2000 mg/kg white mineral oil (Klimisch score = 2, ARCO, 1986). No mortality was noted at this dose level.
Justification for selection of acute toxicity – oral endpoint
One of two acute oral studies
Justification for selection of acute toxicity – inhalation endpoint
One of three acute inhalation toxicity studies
Justification for selection of acute toxicity – dermal endpoint
One of two acute dermal studies
Justification for classification or non-classification
Based on evaluation of all the acute toxicity data discussed above, HRBOs do not meet the criteria for classification as acute oral, inhalation or dermal toxicants under EU CLP Regulation (EC No. 1272/2008).
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