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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
Endpoint summary
Administrative data
Description of key information
Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEL (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils. Sufficiently refined other lubricant base oils are not classified according to DSD for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEC
- 5 mg/m³
- Study duration:
- chronic
- Species:
- rabbit
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rabbit
Additional information
Oral Repeated Dose Toxicity Studies
Subchronic Oral Repeat Dose Toxicity
In a key read-across subchronic oral toxicity study, heavy paraffinic distillate aromatic extract was administered to 10 male Sprague-Dawley rats/dose at dose levels 0, 125, or 500 mg/kg bw/day 5 days a week for 13 weeks (Mobil, 1990a; Klimsich score=1). Four of ten mice in the 500 mg/kg/day group were sacrificed prior to scheduled termination. All animals in the 125 mg/kg/day survived to date of sacrifice. No details on clinical signs were provided. Body weight was significantly reduced in the 500-mg/kg/day group. A significant decrease (p<0.05) in red blood cell (RBC) parameters (including RBC count, haemoglobin, and haematocrit) and platelet in males dosed orally at 500 mg/kg/day. Males orally dosed at 125 mg/kg/day showed a significant decrease in RBC parameters; platelet counts were slightly decreased in these rats but did not achieve statistical significance. There were no significant differences in the RBC morphology or WBC differential data. The only statistically significant difference between the serum data from control and orally dosed rats was observed for SDH (0 mg/kg/day = 5±2 IU/l, 150 mg/kg/day = 8±2 IU/l, 500 mg/kg/day = 9±7 IU/l). Treatment-related dose-dependent changes in relative organ weights included increased liver weight in both groups, decreased prostate weight in both groups, decreased seminal vesicle weight in the high-dose group, and decreased thymus weight in both groups. Focal areas of red discoloration and or generalized reddening were also observed in the brain, spinal cord, stomach and testes of many of the rats dosed orally at 500 mg/kg/day. Treatment-related histopathology was generally dose-dependent and occurred in the following tissues: adrenals, bone marrow, liver, stomach and thymus. Atrophy occurred in the male sex organs (testes, seminal vesicle, and prostate). Sperm evaluations showed a significant increase in the frequency of sperm with abnormal heads in the rats dosed orally at 500 mg/kg/day (1.9% in controls and 3.2% in treated rats).
NOAEL for heavy paraffinic distillate aromatic extract could not be identified and is less than 125 mg/kg/day when administered orally. This compound is a distillate aromatic extract and provides a worst case scenario for insufficiently refined other lubricant base oils due to the concentration effect of the solvent extraction process.
Dermal Repeated Dose Toxicity Studies
Short-term Dermal Repeat Dose Toxicity
A number of 28-day repeat dose dermal toxicity studies have been conducted on other lubricant base.
In a key study conducted according to OECD Guideline 410 (Klimisch score = 1), dermal effects of hydrotreated heavy naphthenic oil (CAS 64742-52-5) were evaluated (sufficiently refined, IP 346 < 3%, API, 1987b). There was no mortality observed at any concentration tested. Statistically significant treatment-related decreases in mean body weight were observed in males and females at the 2000 mg/kg concentration. As well as irritation noted at various doses, topical administration of hydrotreated heavy naphthenic oil at 2000 mg/kg to both male and female rabbits was seen to induce changes in the liver characterized by multifocal to diffuse enlargement of hepatocytes (hepatocytomegaly) accompanied by multifocal areas of inflammation (subacute hepatitis). The systemic toxicity NOAEL is 1000 mg/kg, based on the lack of adverse systemic effects observed at this dose level.
The American Petroleum Institute (API, 1982a; 1982b; 1982c; 1982d; 1982d; 1982e; 1982f; 1982g) conducted an additional series of supporting short-term (28-day) dermal studies in rabbits using 10 different lubricant base oils (sufficiently refined, IP 346 < 3%, Klimisch score = 2). The studies were carried out using similar protocols as that of the key study, and although they were not OECD guideline studies, they were nevertheless robust studies and underwent a quality assurance audit. In these studies, undiluted test material was applied to the occluded skin of male and female New Zealand White rabbits 6 hours, 3 times weekly for up to 4 weeks. The most consistent finding with all materials tested was the occurrence of skin irritation which ranged from minimal to moderate. Other effects, confined to one hydrotreated base oil, were an increase in liver weight along with increases in Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) at a dose level of 2000 mg/kg. Although SGOT and SGPT were also elevated at 1000 mg/kg in one study, no other effects were observed at that dose level. In summary, based on a review of the available data, the NOAELs for these 28-day repeat dose dermal studies are 1000 mg/kg.
Supporting dermal toxixity data are also available from a study conducted by Trimmer et al. 1989. This study was conducted for 28-days using five paraffinic base oils administered at a dose of 1000 mg/kg bw/day. These lubricant base oils were applied to the shorn skins of New Zealand rabbits in an occluded manner, 5 times weekly for 28 days, and, some irritation was observed, most likely exacerbated by the occlusive patch conditions, but no other effects were observed. The NOAEL was therefore determined to be 1000 mg/kg.
Based on the above data, the systemic dermal NOAEL for other lubricant base oils is 1000 mg/kg bw/day.
Subchronic Dermal Repeat Dose Toxicity
In a 90-day dermal toxicity key study (Klimisch score = 1, Mobil Environmental and Health Science Laboratory, 1983a), effects of Stock 141 (a sufficiently refined other lubricant base oil, IP 346 < 3%) on rat skin were assessed according to OECD Guideline 411. Treatment-related pathologies occurred in all groups, were never severe, and included liver enlargement and microscopic skin changes. The absolute liver weight was 19% larger in males treated with Stock 141 than in control males. The relative liver weight was 17% larger. The skin of the controls (sham-treated) showed epidermal thickening (hyperplasia), slight in males and trace in females. The skin of most test-treated animals showed epidermal hyperplasia (trace to mild, in excess of that in the controls) and/or trace chronic inflammation of the superficial dermis. Both findings were very minimal in animals treated with Lubricant base oil Stock 141. The study authors conclude that these findings are not biologically significant. The NOAEL is greater than 2000 mg/kg/day based on lack of local or systemic toxic effects.
An additional 90-day supporting study (Mobil Environmental and Health Science Laboratory (1983b); Klimisch score = 1) on a sufficiently refined lubricant base oil had a LOAEL=1720 mg/kg. Only one dose was used, and the LOAEL was based on morphological degenerative effects on the liver (occasional small aggregates of cells with foamy-appearing cytoplasm). The liver effects were thought to be of minimal pathological significance.
Chronic Dermal Repeat Dose Toxicity
Sufficiently Refined Other Lubricant Base Oils (IP 346 < 3%)
In a key chronic dermal carcinogenicity study (Klimisch score = 1), male C3H/HeNCrlBR mice (50/group) were dermally exposed to propane deasphalted mildly hydrofined and dewaxed residuum from low cold test crude (IP 346 < 3%, sufficiently refined) and the appropriate controls at a frequency of twice per week for 24 months or until observation of carcinoma at which time the animal was sacrificed (ExxonMobil Biomedical Sciences, Inc., 1991). The dermal application of the test materials produced considerable irritation in the positive control group (group 951) and in the vehicle control group (group 722). This irritation was noted macroscopically as desquamation, exfoliation, atonia, eschar, erythema and/or oedema. Microscopic examination revealed acanthosis and subepidermal inflammatory infiltrate. Treatment groups 011, 012, 014, 016 and the negative control group 721 were generally free of dermal irritation during most of the study and at histopathological examination. Forty-five of the fifty Group 951 animals (positive control) had confirmed squamous cell carcinomas at histopathology. All other groups were free of any skin neoplasms. With the exception of the positive control group, there were no statistical differences in time to tumour and tumour production between groups. Survivorship analysis indicated that the positive control displayed the lowest survivorship; however, this finding is related to the fact that animals were euthanized following the appearance of a carcinoma. The test materials did not cause local or systemic effects when applied neat. The NOAEL was determined to be 150 mg/kg bw/day.
Inhalation Repeated Dose Toxicity Studies
Short-term Inhalation Repeat Dose Toxicity
Key 28-day repeat dose inhalation toxicity studies (Klimisch score = 2) have been conducted on three different other lubricant base oils with IP 346 < 3% (sufficiently refined) (Dalbey, et al., 1991). In the first study, Sprague-Dawley rats were exposed to an aerosol of a severely hydrotreated and hydrocracked heavy paraffinic oil (CAS No. 64742-54-7). Viscosity of the oil was 161 SUS at 40°C (approximately 34 mm2/s). Mean aerosol concentrations were 0, 47, 220, and 980 mg/m3; mass median aerodynamic diameter (MMAD) was ~1.2mm and GSD was ~1.8. Endpoints included a haematological profile (cell counts, differential, haemoglobin, haematocrit, cell volumes), 22 clinical chemistry measurements (e.g., plasma enzymes, proteins, electrolytes,etc.), weights of 7 organs (lung, liver, kidney,etc.), and histopathology of major organs. A second, similar study was conducted with a solvent-extracted, catalytically dewaxed heavy paraffinic oil (CAS No. 64742-70-7), and a third study utilized a severely hydrotreated and acid-washed white oil (CAS No. 8042-47-5). Except for the lung and associated lymph nodes, no significant changes were observed following the last exposure for each of the three mineral base oils. The main changes in the lungs were concentration-related accumulations of foamy macrophages (FM) in alveoli, particularly those near alveolar ducts. A mild infiltrate of neutrophils and lymphocytes was sometimes observed with the FM, and the alveolar wall was slightly thickened near accumulations of FM at the higher aerosol concentrations. A mild accumulation of alveolar macrophages in the absence of other significant toxicity does not constitute an adverse effect. Thus, the NOEL for lung changes associated with oil deposition in the lungs was 220 mg/m3. As no systemic toxicity was observed, the overall NOAEL for systemic effects was > 980 mg/m3.
Two solvent-extracted paraffinic mineral base oils (sufficiently refined, IP 346 < 3%) were evaluated in supporting 2-week inhalation toxicity studies (Klimisch score = 2; Exxon Biomedical Sciences, Inc., 1991a; 1991b & Whitman, 1989). The oils spanned a range of 60 – 150 SUS @ 40°C, approximately 12-30 mm2/s). Rats were exposed 6 hours/day to aerosol concentrations of approximately 0, 50, 500, and 1500 mg/m3. There were no mortalities. Exposure-related changes were noted in animals from the most highly exposed groups. These changes, including focal infiltrations of inflammatory cells, focal hyperplasia and squamous metaplasia of the nasal mucosa, and accumulations of inflammatory exudates in the lumen of the nasal cavity, were interpreted as the result of a mild irritating process in the nasal mucosa. No other microscopic changes were observed in any other tissues that indicated systemic toxicity from exposure to the lubricant base oils. The NOAELs for pulmonary effects were 500 mg/m3, and the NOAELs for systemic effects resulting from inhalation exposure were >1500 mg/m3.
Subchronic Inhalation Repeat Dose Toxicity
Sufficiently Refined Other Lubricant Base Oils (IP 346 < 3%)
In a 90-day supporting study (Dalbey, 2001) on inhalation toxicity (Klimisch score = 2), rats were exposed to three formulated sufficiently refined lubricant base oils (cutting oil, gear oil, and commercial engine oil; IP 346 < 3%). The study showed no systemic effects, and only mild accumulation of alveolar macrophages in lungs (consistent with oil deposition). The NOAELs were estimated as 50-150 mg/m3.
Chronic Inhalation Repeat Dose Toxicity
Sufficiently Refined Other Lubricant Base Oils (IP 346 < 3%)
In an older, supporting chronic study (Klimisch score = 4), five species (dog, rabbit, rat, hamster, and mouse) were exposed for 12 to 26 months, for 6 hours per day, to a sufficiently refined petroleum base mineral oil mist (materials similar in composition to OLBOs; IP 346 < 3%) at concentrations of 5 and 100 mg/m3(Wagner et al., 1964). The mineral oil contained 85% naphthenes and 5% paraffins and the Saybolt viscosity was given at 85-95, making this oil comparable in viscosity to light motor oil. Mice were exposed daily for 6 hr at 5 mg/m3for 12 months or at 100 mg/m3for 16 months. For dogs, 6, 12, or 26 months of daily 6-hr exposures were conducted for the 5 and 100 mg/m3concentrations. Rabbits were exposed at 5 mg/m3daily for 6 or 12 months or at 100 mg/m3daily for 6, 12, or 18 months. Rats and hamsters were exposed similarly to rabbits, the exception being that the rat and hamster 100 mg/m3groups were sacrificed at 16 and 15 months, respectively. The study showed no systemic effects, resulting in a systemic NOAEL of >100 mg/m3. Macrophage accumulation was found in lungs of animals exposed at the high dose, so the NOAEL for lung effects is 5 mg/m3.
Repeated dose toxicity: inhalation - systemic effects (target organ) respiratory: lung
Justification for classification or non-classification
Sufficiently refined other lubricant base oils (IP 346 < 3%) are not classified according to EU DSD for repeat-dose toxicity.
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