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EC number: 265-057-8 | CAS number: 64741-56-6 A complex residuum from the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C34 and boiling above approximately 495°C (923°F).
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study report is classified as reliable with restrictions because it is an acceptable and a well-documented study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Vacuum residue
- IUPAC Name:
- Vacuum residue
- Reference substance name:
- 64741-56-6
- Cas Number:
- 64741-56-6
- IUPAC Name:
- 64741-56-6
- Test material form:
- other: semi-solid
- Details on test material:
- - Name of test material (as cited in study report): Vacuum Residuum (API 81-13) CAS No. 64741-56-6
- Substance type: Bitumen
- Physical state: Tar-like semi-solid
- Composition of test material,
weight percentage of components: Sample API 81-13: 4.46% sulphur, 0.51% nitrogen, 90+% carbon; 6.5% asphaltenes
<1 ppm copper, 33 ppm iron, 39 ppm vanadium, 18 ppm nickel
- Lot/batch No.: API 81-13
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: Stored at room temperature in original containers
- Other:Sample 81-13 was selected because of its high sulphur and asphaltene contents
- Distillation (ASTM D 11-60) °F- Initial Boiling Point 650
- Gravity API: 6.6
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, MI
- Age at study initiation: Approximately 7 weeks of age
- Weight at study initiation: 181 to 271 grams
- Fasting period before study: Overnight
- Housing: Group cages
- Diet (e.g. ad libitum): Ad libitum (continuous access to certified Purina rodent chow)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 32 to 64
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): No data
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg body weight
- Doses:
- 20 mL test material/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing: initial day, day 7, and day 14. Observed hourly for the first 6 hours and then twice daily until day 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight,gross necropsy
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Hypoactivity, diarrhea, dark brown / black staining of the anal region
- Other findings:
- Body weight:
Average (grams):
pre-fast: 281 (m), 215 (f)
initial: 256 (m), 193 (f)
7 days: 317 (m), 231 (f)
14 days: 339 (m), 244 (f)
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information LD50 is greater than 5000 mg/kg body weight; not classified under CLP (EC 1272/2008) Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the oral LD50 was determined to be greater than 5000 mg/kg body weight in males and females. Vacuum Residuum is not classified under CLP (EC 1272/2008).
- Executive summary:
In an acute oral toxicity study, groups of fasted, Sprague-Dawley rats (5/sex) were given a single oral dose of Vacuum Residuum in corn oil at a dose of 20 mL/kg body weight and observed for 14 days. Clinical observations include: hypoactivity, diarrhea and dark brown / black staining of the anal region. The oral LD50 was determined to be greater than 5000 mg/kg body weight in males and females.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable and a well-documented study report.
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