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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
Study period:
1982-01-07 to 1982-01-21
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)
Deviations:
yes
Remarks:
The temperature of the animal room ranged from 68.0 to 73.4 degrees Fahrenheit and the relative humidity ranged from 32 to 64%.
Principles of method if other than guideline:
Dosed 5 male and 5 female Sprague-Dawley rats with single dose of test material by gavage. Monitored the animals for 14 days after which gross necropsy was performed.
GLP compliance:
yes (incl. QA statement)
Remarks:
American Petroleum Institute Medicine and Biological Science Department
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
64742-80-9
Cas Number:
64742-80-9
IUPAC Name:
64742-80-9
Constituent 2
Reference substance name:
Hydrodesulfurised middle distillate
IUPAC Name:
Hydrodesulfurised middle distillate
Test material form:
other: low viscosity liquid hydrocarbon
Details on test material:
- Name of test material (as cited in study report): API# 81-09 (CAS# 64742-80-9)
- Substance type: clear liquid
- Gravity API: 38.1
- Sulfur wt %:0.15
- Nitrogen ppm: <10
- Flash pt. °F: 255
- Boiling range (ASTM D-86) 10-95%: 519-562 °F
- Initial Boiling Point 502 °F
- End Boiling Point 574 °F
- Composition %:
paraffins 46.0
olefins 2.5
naphthenes 26.5
aromatics 25.0

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 Labs, Portage, Michigan
- Age at study initiation: Approximately 7 weeks of age
- Weight at study initiation: Male - 246 grams, Females - 191 grams
- Fasting period before study: food was removed overnight prior to initiation
- Housing: group cages prior to initiations and individually housed after initiation
- Diet (e.g. ad libitum): Purina certified rodent chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68.0 to 73.4°F
- Humidity (%): 32 to 64%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1982-01-07 To: 1982-01-21

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
No vehicle used

MAXIMUM DOSE VOLUME APPLIED: 6.10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: greater than 5.0 g/kg of body weight
Doses:
6.10 mL/kg ( equivalent to 5000 mg/kg)
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: Observed hourly during first 6 hours after initiation then twice daily. Weighed during pre-fast, initiation, after 7 days and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: pharmacotoxic signs
Statistics:
Not Performed

Results and discussion

Preliminary study:
Not conducted
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
There was no mortality at the 5,000 mg/kg bw dose.
Clinical signs:
Pharmacotoxic signs observed included hypoactivity, urine stained abdomen and oily looking hair.
Body weight:
Males - at initiation 246 g, 7 days 295 g, 14 days 326 g
Females - at initiation 215 g, 7 days 228 g, 14 days 241 g
Gross pathology:
Two animals had mildly enlarged cervical lymph nodes, one stomach distended with red-brown material, one left kidney-renal pelvis moderately dilated, one alopecia on entire stomach area.
Other findings:
Not Reported

Any other information on results incl. tables

 

Dosage Level

Average Body Weights (g)

(g/kg)

Pre-Fast

Initial

7 Days

14 Days

Males

5.0

271

246

295

326

Females

5.0

215

191

228

241

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 was determined to be > 5,000 mg/kg bw in both males and females.
Executive summary:

In an acute oral toxicity study, groups of fasted, 7-week old, Albino Sprague-Dawley rats (5 males and 5 females) were given a single oral dose of undiluted hydrodesulfurised middle distillate at doses of 6.10 mL/kg (>5,000 mg/kg bw) and observed for 14 days. 

 

There was no mortality or abnormal changes in body weight. Treatment related clinical signs included hypoactivity, urine stained abdomen, and oily looking hair. Necropsy findings on the animals revealed two mildly enlarged cervical lymph nodes, a distended stomach, renal pelvis moderately dilated, and alopecia on the stomach area. The oral LD50 was determined to be > 5,000 mg/kg bw 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.