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EC number: 276-737-9 | CAS number: 72623-86-0 A complex combination of hydrocarbons obtained by treating light vacuum gas oil and heavy vacuum gas oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of approximately 15cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
- 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://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1986-12-02 to 1987-03-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without because it was a well conducted study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 64742-04-7
- Cas Number:
- 64742-04-7
- IUPAC Name:
- 64742-04-7
- Reference substance name:
- Heavy paraffinic distillate aromatic extract
- IUPAC Name:
- Heavy paraffinic distillate aromatic extract
- Test material form:
- other: Oily liquid
- Details on test material:
- Read across from untreated distillate aromatic extracts
- Name of test material (as cited in study report): 318 Isthmus Furfural Extract
- Substance type:heavy paraffinic distillate solvent extract (petroleum)
- Physical state: liquid
- Analytical purity: not provided
- Impurities (identity and concentrations): not provided
- Composition of test material, percentage of components (wt. %): total non-aromatics- 22.3, total aromatics- 77.7%, less than 3 ring polynuclear aromatic hydrocarbons- 37.2%, 3 to 5 ring polynuclear aromatic hydrocarbons- 23.0%, N-polynuclear aromatic hydrocarbons- 2.3% (non-basic = 1.6; basic 0.7), S-polynuclear aromatic hydrocarbons- 12.8%
- Isomers composition: not provided
- Purity test date: not provided
- Lot/batch No.: CRU no. 86187
- Expiration date of the lot/batch: April 30, 1991
- Stability under test conditions: 5 years
- Storage condition of test material: not provided
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic, Germantown, NY
- Age at study initiation: 49 days
- Weight at study initiation: not reported
- Fasting period before study: not reported
- Housing: individual housing in hanging stainless steel cages with wire bottoms and fronts
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13 days in a quarantine room
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21°C
- Humidity (%): 40 to 60%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES:
From 1986-12-02 to 1987-03-06
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data provided.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data reported.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Five days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
125 or 500 mg/kg/day via oral gavage
Basis:
no data
- No. of animals per sex per dose:
- 10 male rats per dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- No data reported.
- Positive control:
- No data reported.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice a day
- Cage side observations included morbidity and mortality.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: study initiation and weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: weeks 5 and 13
- Anaesthetic used for blood collection: Yes (diethyl ether)
- Animals fasted: Yes
- How many animals: all animals
- Parameters in table 1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: weeks 5 and 13
- Animals fasted: Yes
- How many animals: all animals
- Parameters in table 2 were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: weeks 5 and 13
- Metabolism cages used for collection of urine: No data
- Animals fasted: Yes
- Parameters in table 3 were examined.
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, but details were not provided.
HISTOPATHOLOGY: Yes (see table 4) - Other examinations:
- Organ weights double XX in table 4 were weighed. Sperm morphology was examined in the 500 mg/kg/day group.
- Statistics:
- An analysis of variance with associated F-test followed by Student-Newman-Keuls test were used when appropriate.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- 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:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY: 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 AND WEIGHT GAIN: Body weight was significantly reduced in the 500-mg/kg/day group (Table 1)
HAEMATOLOGY: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(Table 2). 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.
CLINICAL CHEMISTRY: 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).
URINALYSIS: There were no treatment-related effects on urinalysis.
ORGAN WEIGHTS:Significantly different absolute and/or relative weights in liver, heart, brain, thymus, prostate, seminal vesicles and adrenal glands compared to control were observed. Some of the effects are secondary to reduced body weight. Those that are considered related to treatment are presented in Table 3.
GROSS PATHOLOGY: 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.
HISTOPATHOLOGY: Treatment-related histopathology was generally dose-dependent and occurred in the following tissues: adrenals, bone marrow, liver, stomach and thymus (Table 9). Atrophy occurred in the male sex organs (testes, seminal vesicle, and prostate).
OTHER FINDINGS: 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).
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Sex:
- male
- Basis for effect level:
- other: adverse effects observed at 125 mg/kg/day dosed orally
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Dose descriptor:
- LOAEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1. Mean group body weights on week of study.
Dose | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 |
0 mg/kg/day | 227.2 | 273.9 | 318.6 | 348.5 | - | 380 | 405.4 | 419.1 | 433.2 | 440.4 | 462.4 | 460.8 | 468.9 | 461.5 |
125 mg/kg/day | 224.4 | 270.9 | 314.5 | 347.7 | - | 375.4 | 395 | 403.9 | 416 | 422.7 | 431.6 | 439 | 451.8 | 445.5 |
500 mg/kg/day | 224.1 | 285.3 | 308.9 | 335.3 | - | 348.8* | 354.3* | 352.2* | 359.9* | 359.1* | 373.2* | 374.6* | 380.1* | 386.5* |
*indicates significantly different from control (p<0.05)
Body weights were inadvertently not measured on week 5.
Table 2. Haematological parameters at the end of the study period.
Haematological Parameter | 0 mg/kg/day | 125 mg/kg/day | 500 mg/kg/day |
RBC(106/mm3) | 9.17 | 8.72 | 8.51* |
WBC (103/mm3) | 14.4 | 13.3 | 12.7 |
Platelets (10^3/mm3) | 1152 | 1055 | 930 |
Hgb (g/dl) | 17.1 | 16.0* | 15.2* |
Hct (%) | 53.7 | 50.7* | 47.7* |
MCV (cubic microns) | 59 | 58 | 56* |
MCH (pcg) | 18.7 | 18.4 | 17.8* |
MCH Conc. (%) | 31.9 | 31.6 | 31.8 |
*indicates significantly different from control (p<0.05)
Abbreviations: RBC=red blood cells, WBC=white blood cells, Hgb=haemoglobin, Hct=haematocrit,
MCV=mean corpuscular volume, MCH=mean corpuscular haemoglobin
Table 3. Mean final fasted body weight and relative organ weights in grams.
Body/Organ Weight |
0 mg/kg/day |
125 mg/kg/day |
500 mg/kg/day |
Final Body Weights |
435.1±36.7 |
407.1±32.6 |
350.3±29.4* |
Liver |
3.03±0.24 |
4.17±0.40* |
5.29±0.46* |
Prostate |
0.26±0.03 |
0.20±0.05* |
0.11±0.07* |
Seminal Vesicles |
0.20±0.04 |
0.18±0.05 |
0.12±0.04* |
Thymus |
0.093±0.029 |
0.054±0.015* |
0.018±0.007* |
Table 4
Incidences of treatment-related histopathology after dermal exposure to 318 Isthmus Furfural Extract for 13 weeks |
|||
|
Control |
125 mg/kg/day |
500 mg/kg/day |
Males |
n=10 |
n=10 |
n=10 |
vacuolation, cortical |
0
|
Not examined |
3 |
hyperplasia, zona glomerulosa
|
0 |
Not examined |
2 |
decreased cellularity in femur |
0 |
4 |
8 |
Fibrosis in femur |
0 |
1 |
5 |
decreased cellularity in sternum |
0 |
2 |
7 |
Fibrosis in sternum |
0 |
0 |
4 |
haemorrhage, multifocal (brain) |
0 |
Not examined |
5 |
Dialation, sinusoidal, centrilobular |
0 |
0 |
3 |
Hypertrophy, hepatocytes |
0 |
0 |
9 |
Necrosis, centrilobular |
0 |
0 |
4 |
Vacuolation, hepatocellular, periportal |
0 |
2 |
5 |
Atrophy (prostate) |
0 |
Not examined |
9 |
Atrophy (seminal vesicle) |
0 |
Not examined |
5 |
Congestion/haemorrhage, glandular mucosa |
0 |
Not examined |
4 |
Hyperplasia/hyperkeratosis, limiting ridge |
0 |
Not examined |
8 |
Atrophy (thymus) |
0 |
9 |
10 |
Applicant's summary and conclusion
- Conclusions:
- NOAEL for heavy paraffinic distillate aromatic extract could not be identified and is less than 125 mg/kg/day when administered orally.
- Executive summary:
Read across justification
This compound is an untreated 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.
In a 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. 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 study received a Klimisch score of 1 and is classified as reliable without restriction because it is a well conducted study.
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