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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
other:
Limit test:
no

Test material

Constituent 1
Reference substance name:
Vacuum residue (CAS # 64741-56-6)
IUPAC Name:
Vacuum residue (CAS # 64741-56-6)
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: Semi-solid (tar like)

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 and black anal region

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 EU Dangerous Substances Directive 67/584/EEC 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 EU Dangerous Substances Directive 67/548/EEC.
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 at a dose of 20 mL/kg body weight and observed for 14 days. Clinical observations include: hypoactivity, diarrhea, dark brown and black anal region. The oral LD50 was determined to be greater than 5000 mg/kd 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.