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Toxicological information

Acute Toxicity: oral

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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:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
Hypoactivity, diarrhea, dark brown / black staining of the anal region
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.