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EC number: 309-874-0 | CAS number: 101316-69-2 A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of vacuum distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C25 and produces a finished oil with a viscosity in the order of 32cSt to 37cSt at 100°C (212°F).
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- No data reported.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was carried out according to OECD Guideline 474.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- solvent-extracted, dewaxed paraffin oils, sufficiently refined, IP 346 < 3%
- IUPAC Name:
- solvent-extracted, dewaxed paraffin oils, sufficiently refined, IP 346 < 3%
- Test material form:
- other: Oily liquid
- Details on test material:
- SDPO = solvent-extracted, dewaxed paraffin oil. The only details provided about each paraffin oil were the viscosity and percentage of sulphur (presented in a table in the additional methods information).
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The following data were not provided:
Number of animals dosed per sex
Age of anmials
Environmental conditions of animals
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- corn oil
- Details on exposure:
- Test materials were suspended in corn oil and administered by intraperitoneal injection.
- Duration of treatment / exposure:
- No data reported.
- Frequency of treatment:
- Single intraperitoneal injection.
- Post exposure period:
- Bone marrow was harvested at 24, 48, and 72 hours after exposure.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1, 2.5, or 5.0 g/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- No data provided.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide in water at 20 mg/kg.
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- No data provided.
- Evaluation criteria:
- No data provided.
- Statistics:
- No data provided.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- All but one mouse survived to the scheduled sacrifice, and there was no gross evidence of toxicity. In only one case was the micronucleus frequency significantly greater than the concurrent negative control. In this particular case, the negative control was unusually low. The positive and negative controls responded as expected, confirming the integrity and sensitivity of the assay system.
Any other information on results incl. tables
Table 1. Micronucleus Tests of Mineral Hydrocarbons in Female CD-1 Mice |
||||||
Sacrifice Time |
Dose Level |
Sample Number |
||||
|
|
1 |
2 |
3 |
4 |
5 |
24 Hours |
vehicle |
0.6±0.9 |
0.4±0.5 |
1.8±1.5 |
1.8±0.8 |
2.6±1.5 |
|
1.0 g/kg |
2.0±1.6 |
1.0±1.7 |
1.2±0.8 |
1.4±1.1 |
1.0±1.2 |
|
2.5 g/kg |
1.4±0.5 |
0.8±0.8 |
2.6±1.5 |
1.2±0.8 |
2.0±0.7 |
|
5.0 g/kg |
0.6±0.9 |
1.0±1.2 |
0.8±0.8 |
0.6±0.5 |
1.4±9.4 |
48 Hours |
vehicle |
0.2±0.4 |
0.6±0.9 |
0.8±1.1 |
1.2±1.3 |
1.4±1.7 |
|
1.0 g/kg |
0.0±0.0 |
0.4±0.5 |
1.6±2.1 |
2.0±2.9 |
0.4±0.5 |
|
2.5 g/kg |
0.2±0.4 |
0.6±0.9 |
1.0±0.7 |
2.2±1.3 |
0.8±0.8 |
|
5.0 g/kg |
1.0±1.4 |
1.0±0.7 |
1.0±1.0 |
1.8±1.3 |
1.6±1.1 |
72 Hours |
vehicle |
1.4±0.5 |
0.6±0.9 |
2.0±1.2 |
0.6±0.5 |
1.6±0.5 |
|
1.0 g/kg |
0.6±0.9 |
1.4±1.1 |
0.2±0.4** |
0.6±0.9 |
0.6±0.9 |
|
2.5 g/kg |
1.0±0.7 |
0.4±0.5 |
0.8±0.4** |
1.4±0.5 |
1.8±1.6 |
|
5.0 g/kg |
2.2±1.6 |
0.6±0.5 |
1.0±1.0 |
1.2±1.1 |
1.8±1.5 |
Positive Control |
20 mg/kg cyclophosphamide |
10.8±3.9** |
9.2±4.1** |
10.4±3.6** |
12.8±4.0** |
15.8±9.4** |
|
||||||
**Significantly different from control at p<0.01 |
||||||
Positive control tested at 24 hours only |
Table 2. Micronucleus Tests of Mineral Hydrocarbons in Male CD-1 mice |
||||||
Sacrifice Time |
Dose Level |
Sample Number |
||||
|
|
1 |
2 |
3 |
4 |
5 |
24 Hours |
vehicle |
0.8±0.8 |
1.6±1.5 |
4.0±1.6 |
2.2±0.8 |
2.6±1.8 |
|
1.0 g/kg |
1.8±1.8 |
1.6±2.5 |
3.0±1.4 |
1.6±1.1 |
1.4±1.3 |
|
2.5 g/kg |
1.2±1.3 |
1.2±1.3 |
0.6±0.5 |
2.2±0.8 |
1.4±2.1 |
|
5.0 g/kg |
0.4±0.5 |
1.8±1.6 |
2.0±1.9 |
1.4±0.5 |
1.8±1.3 |
48 Hours |
vehicle |
0.0±0.0 |
1.0±1.0 |
1.4±0.5 |
1.0±0.7 |
1.6±1.8 |
|
1.0 g/kg |
0.0±0.0 |
0.8±0.4 |
1.0±1.0 |
2.0±1.4 |
1.4±1.7 |
|
2.5 g/kg |
0.0±0.0 |
0.4±0.9 |
0.6±0.5 |
0.6±0.5 |
1.0±0.7 |
|
5.0 g/kg |
1.6±1.3** |
0.6±0.9 |
0.8±0.8 |
1.4±1.3 |
1.8±0.8 |
72 Hours |
vehicle |
0.8±0.8 |
0.6±0.5 |
1.2±1.3 |
2.0±1.1 |
0.8±0.8 |
|
1.0 g/kg |
1.0±1.2 |
0.8±0.8 |
1.2±0.8 |
0.4±0.9 |
1.4±1.7 |
|
2.5 g/kg |
2.0±1.6 |
0.4±0.5 |
1.0±1.2 |
1.0±1.7 |
0.8±0.8 |
|
5.0 g/kg |
1.4±0.5 |
0.6±0.5 |
0.6±0.5 |
0.8±0.8 |
1.0±1.2 |
Positive Control |
20 mg/kg cyclophosphamide |
12.2±5.6** |
7.2±3.8** |
11.0±6.7** |
12.0±2.9** |
17.4±5.0** |
**Significantly different from control at p<0.01 |
||||||
Positive control tested at 24 hours only |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The five mineral hydrocarbons tested in the mouse micronucleus assay were not clastogenic.
IP346 data were not available for these samples. Accordingly it was not possible to differentiate them on the basis of IP 346 levels. However, as described in the report on unrefined and acid treated oils (CONCAWE, 2007), a distillate aromatic extract was not active when tested in this assay. Accordingly, if the aromatic constituents of these oils are not active when tested separately, it seems reasonable to assume that none of the oils in the lubricant base oil category would be active in bone marrow assays for chromosomal mutations. - Executive summary:
In a CD-1 mouse bone marrow micronucleus assay, male and female mice were given a single intraperitoneal injection of 5 different paraffin oils in corn oil vehicle at doses of 0, 1.0, 2.5, or 5.0 g/kg. Bone marrow cells were harvested at 24, 48, and 72 hours post-dosing. One animal did not survive to scheduled sacrifice, but there were no gross signs of toxicity. The micronucleus frequency was significantly greater than the concurrent negative control in bone marrow cells of male mice given 5.0 g/kg at 48 hours post-dosing, but the negative control was unusually low in this instance, and therefore this result is not considered significant.
This study received a Klimisch score of 1 and is considered reliable without restriction because it was carried out according to OECD Guideline 474.
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