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EC number: 271-384-7 | CAS number: 68553-00-4 A distillate oil having a minimum viscosity of 900 SUS at 37.7°C (100°F) to a maximum of 9000 SUS at 37.7°C (100°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
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Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline, GLP-compliant study. Adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4900 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- The test substance was applied to clipped dorsal skin of groups of pregnant female rats at dose levels of 0, 0.05, 1, 10, 50 or 250 mg/kg bw/d on GD 0-19. Dams were observed daily for clinical signs (including skin reactions: Draize criteria). Maternal body weight was recorded on GD 0, 6, 9, 12, 15, 18 and 20. Food consumption data were recorded regularly (collection period not stated). Dams were sacrificed (carbon dioxide) on GD 20 and subject to gross necropsy, including an examination of the uterus and its contents.
Foetuses were examined for viability and the sex of each and presence of any gross external lesions noted. Approximately one half of the foetuses were processed for soft tissue examination, the remainder for skeletal alterations. - GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 64741-62-4
- Cas Number:
- 64741-62-4
- IUPAC Name:
- 64741-62-4
- Test material form:
- other: Viscous hydrocarbon liquid
- Details on test material:
- - Name of test material (as cited in Sponsor documentation): clarified slurry oil, CSO
- Specific gravity = 1.06
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI.
- Age and weight at study initiation: not reported
- Housing (GD 0-19): individually housed in stainless steel, wire mesh-bottomed cages
- Diet (ad libitum): Certified Rodent Chow 5002 (Purina Mills Inc.)
- Water (ad libitum): membrane filtered tap water
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-26 degrees
- Humidity (%): 40-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: not reported
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- other: applied neat or in acetone
- Details on exposure:
- The test substance was applied neat to previously clipped intact skin on the dorsum. Animals from the 1-250 mg/Kg bw/d groups along with the sham control group were fitted with “Elizabethan collars” (to minimise ingestion) which were worn continuously from GD 0 to GD 20). Animals from the 0.05 mg/Kg bw/day and acetone control groups were fitted with collars for 6 hr post-treatment.
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- Each female was placed with one male (same strain and source) overnight and examined the following day for evidence of mating (e.g. sperm in vaginal smear or presence of copulatory plug taken as Day 1 of pregnancy).
- Duration of treatment / exposure:
- 6 hr / d
Test site cleaned with acetone post-treatment. - Frequency of treatment:
- Daily, GD 0-19
- Duration of test:
- From GD 0 to GD 19
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.05, 1, 10, 50, 250 mg/Kg bw/d
Basis:
nominal conc.
- No. of animals per sex per dose:
- 24 females per treatment group
- Control animals:
- yes, concurrent vehicle
- yes, sham-exposed
- Details on study design:
- Test sample applied open (i.e. test site not covered)
Treatments for the 1, 10, 50 and 250 mg/Kg bw/day groups were applied neat; controls were sham-treated.
Treatments for the 0.05 mg/Kg bw/day group were diluted in acetone and applied at a volume of 1 ml/kg bw/day; controls received acetone.
Examinations
- Maternal examinations:
- - Clinical observations
- Body weight
- Food consumption
- Gross necropsy - Ovaries and uterine content:
- - The number of corpora lutea, number of implantation sites and number of early/late resportions recorded
- Uteri from apparently non-gravid dams were stained and examined while transilluminated and pressed between two glass plates - Fetal examinations:
- - Viability, gender, body weight and gross external alterations
- Approx. 50% of foetuses fixed in Bouin's solution and examined for soft tissue alterations (Wilson technique)
- Remainder eviscerated, cleared and stained with alizarin red and examined for skeletal alterations
Foetal alterations were defined by the study authors as either:
(i) malformations: irreversible changes that occur at low incidence in this species and strain; or
(ii) variations: common findings in this species and strain and/or reversible delays in development. - Statistics:
- - Maternal body weight and food consumption: Bartletts test followed by ANOVA/Dunnett's test (if variances equal) or Kruskal-Wallis test/Dunn's Summed Rank test (if variances unequal)
- Reproductive / Litter data: ANOVA followed by weight or unweighted GLM analysis
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
- Clinical signs:
There were no maternal deaths, abortions, premature deliveries or any irritation of the test site in any group during the study.
- Body weight / body weight gain:
Maternal feed consumption and maternal body weight were significantly decreased, in a dose-related manner, at 1 mg/kg bw/day and above. Net maternal body weight was significantly decreased in a dose related manner (approx. 5-25%) and accompanied by a marked dose-related reduction (approx. 30-90%) in net maternal body weight gain.
-Necropsy:
Gross necropsy findings were unremarkable.
- Pregnancy
Red vaginal discharge was observed in 20-80% of animals dosed with the test substance at 1 mg/kg bw/day and above (affecting 0, 9, 5, 14 and 19 dams given 0.05, 1, 10, 50 or 250 mg/kg bw/day, respectively). Significant, dose-related reductions in gravid uterine weight (decreased 40-95%) were apparent in dams receiving 1 mg/kg bw/day and above.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 0.05 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 0.05 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
- Litter parameters:
The number of dead or resorbed foetuses was increased 8-16 fold over that of the controls in the 1, 10 and 50 mg/Kg bw/day groups with total litter resorption in high dose dams.
- Body weight:
Foetal body weight was also significantly decreased (14-25%) at 1 mg/kg bw/day and above.
- Soft tissue findings:
There were no treatment-related gross external malformations, however the incidence delayed development in soft tissues (defined as variations, and covering moderate dilation of the renal pelvis, slight dilation of the lateral ventricles of the brain) was stated to be increased significantly at 1, 10 and 50 mg/Kg bw/day (data not presented in publication). No adverse or statistically significant findings were apparent at 0.05 mg/Kg bw/day group.
- Skeletal findings:
A reduction in the extent of ossification of the caudal vertebrae, metacarpals and phalanges (defined as variations) was apparent in the 1, 10 and 50 mg/Kg bw/day groups. No adverse or statistically significant findings were apparent at 0.05 mg/Kg bw/day group.
Effect levels (fetuses)
- Remarks on result:
- other: see Details on embyotoxic/teratogenic effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Maternal
parameters (mean, [SD]) by dose level
Maternal bw (g), GD 20:
Data presented graphically, no tabulated (quantitative) information
available.
Corrected maternal bw (g), GD 20:
294.3 [24.6], NC, NC, 275.2 [19.6]*, 269.7 [18.7]**, 247.3 [25.9]**,
217.2 [20.4]**
Corrected maternal bw gain (g), GD 0 to GD 20:
68.6 [18.7], NC, NC, 49.5 [12.5]**, 46.8 [17.0]**, 20.9 [23.2]**, -7.9
[16.5]**
Gravid uterine weight (g):
83.0 [6.9], NC, NC, 49.9 [20.9]**, 29.8 [24.6]**. 8.8 [11.9]**, 3.5
[2.1]**
Number of dams:
20, 23, 24, 21, 23, 22, 22
Caesarian
section and foetal litter data (total or mean and [SD]) by dose level
Live foetuses:
314, 344, 362, 224, 118, 20, 0
Litter size / live foetuses per litter:
14.3 [1.4], 15.0 [2.4], 15.1 [1.7], 9.3 [4.2], 4.9 [4.8], 0.9 [2.2]*, 0
[0]*
Total resorptions per litter:
0.6 [0.7], 1.1 [1.4], 0.8 [1.0], 5.0 [4.7]*, 9.4 [5.3]*, 14.0 [2.8]*,
14.3 [2.1]*
Early resorptions per litter:
0.6 [0.7], 1.1 [1.4], 0.8 [1.0], 4.7 [4.8]*, 9.2 [5.4]*, 13.9 [3.0]*,
14.1 [2.1]*
Dead or resorbed foetuses per litter:
4.1 [4.6], 7.0 [8.2], 4.6 [6.6], 33.8 [30.6]*, 43.6 [24.9]*, 67.6
[14.4]*, -
Foetal body weight – g per litter:
3.52 [0.22], 3.51 [0.41], 3.54 [0.34], 2.94 [0.33]*, 3.02 [0.27]*, 2.62
[0.07]*, -
Number
(%) of dams examined:
22 (100%), 23 (92%), 24 (96%), 24 (100%), 24 (100%), 23 (95.8%), 23
(95.8%)
Number of litters with foetuses with any alteration (%) by dose level:
8 (36.4), 7 (30.4), 10 (41.7), 8 (33.3), 7 (46.7), 2 (50.0), -
Number of foetuses with any alteration (%) by dose level:
8 (2.5), 12 (3.5), 16 (4.4), 11 (4.9), 9 (7.6)*, 3 (15.0)*, -
Foetuses evaluated for alterations (N):
314, 344, 362, 224, 118, 20, 0
Litters evaluated for alterations (N):
22, 23, 24, 24, 15, 4, 0
Statistically significant changes in ossification sites (per foetus per
litter) by dose level:
Caudal vertebrae:
5.03 [0.50], 5.01 [0.62], 5.00 [0.43], 4.20 [0.79]*, 4.24 [0.41]*, 3.52
[0.67]**, -
Metacarpals, mean sites per paw:
3.69 [0.33], 3.59 [0.32], 3.58 [0.38], 3.46 [0.35]**, 3.46 [0.32], 3.02
[0.05]**, -
Phalanges, mean sites per paw :
5.00 [0.00], 4.97 [0.23], 5.00 [0.00], 3.90 [1.77]*, 4.37 [1.40], 1.58
[1.82]*, -
Dose levels: 0 (sham), 0 (vehicle), 0.05, 1, 10, 50 or 250 mg/kg bw/day
Statistics: * = P<0.05; ** = P<0.01
NC = data not collected
- = not applicable (no live foetuses)
Applicant's summary and conclusion
- Conclusions:
- NOAEL for maternal and developmental toxicity = 0.05 mg/Kg bw/day
- Executive summary:
The developmental toxicity of clarified slurry oil (0, 0.05, 1, 10, 50 or 250 mg/Kg bw/day) was investigated in groups of pregnant SD rats after dermal application on GD 0-19. The dams were housed individually and fitted with collars to minimise ingestion during the 6 hr exposure period, and the test site wiped clean (acetone) at the end of the exposure.
There were no maternal deaths, abortions, premature deliveries or any irritation of the test site in any group during the study, however red vaginal discharge (affecting 20-80% of animals) was observed at 1 mg/Kg bw/day and above. Maternal feed consumption and maternal body weight were significantly decreased, in a dose-related manner at 1 mg/Kg bw/day and above. Net maternal body weight and net body weight gain were also significantly decreased in a dose related manner at 1 mg/kg bw/d and above.Significant, dose-related reductions in gravid uterine weight (decreased 40-95%) and an increased incidence of early resorptions (elevated 8-24 fold) were apparent in dams receiving 1 mg/Kg bw/day and above. The number of dead or resorbed foetuses was increased 8-16 fold over that of the controls in the 1, 10 and 50 mg/Kg bw/day groups with total litter resorption in high dose dams. Foetal body weight was also significantly decreased (14-25%) at 1 mg/kg bw/day and above. There were no treatment-related gross external malformations, however the incidence delayed development in soft tissues (variations, including moderate dilation of the renal pelvis, slight dilation of the lateral ventricles of the brain) was stated to be increased significantly (data not presented in publication). A reduction in the extent of ossification of the caudal vertebrae, metacarpals and phalanges (defined as variations) was also apparent in the 1, 10 and 50 mg/Kg bw/day groups. No adverse or statistically significant foetal findings were apparent in 0.05 mg/Kg bw/day group.
The NOAEL for maternal toxicity was 0.05 mg/Kg bw/day (based on decreased net body weight/net body weight gain, a reduction in food intake and the occurrence of vaginal discharge); the NOAEL for developmental toxicity was also 0.05 mg/Kg bw/d (reflecting decreased gravid uterine weight, increased resorptions, decreased live litter size and a reduction in foetal weight).
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