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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:
1985-06-11 to 1985-12-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was well conducted and reported and the methodology was according to or similar to guideline study OECD TG 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
not considered to have an effect on the validity of the study.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
64741-44-2
Cas Number:
64741-44-2
IUPAC Name:
64741-44-2
Constituent 2
Reference substance name:
Straight run middle distillate
IUPAC Name:
Straight run middle distillate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 83-11
- Substance type: Straight run middle distillate
- Physical state: Clear, pale-yellow liquid
- CAS number: 64741-44-2
- Gravity API: 36.2
- Sulfur wt %:0.30
- Nitrogen ppm: 80
- Boiling range (ASTM D-86 equiv) 10%: 488 °F
- Initial Boiling Point 366 °F
- End Boiling Point 735 °F
- Viscosity at 40°C cSt: 4.16
- Aniline Point °F: 171
- Composition % by MS:
olefins 2.0
aromatics 21.0
saturates 77.0

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 Laboratory, Wilmington, Massachusetts.
- Age at study initiation: Approximately 7 weeks
- Weight at study initiation: 286 to 327 grams males prior to fasting, 214 and 226 grams for females prior to fasting
Food was withheld during an overnight period prior to test material administration.
- Fasting period before study: Yes
- Housing: individual cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation Period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 degrees C to 23 degrees C
- Humidity (%): 38% t o 50% relative humidity
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test substance was administered undiluted in a single gavage dose
Doses:
The test substance was administered undiluted in a single gavage dose of 5000 mg/kg body weight.
Rationale for the selection of the starting dose: The dose volume of the test material was 6.02 mL/kg of body weight based upon the average bulk density of 0.83 g/mL.
No. of animals per sex per dose:
Five male and five female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed every hour for six hours after test material administration. Body weights were taken before fasting, prior to test material administration, and at 7 and 14 days following test material.
- Necropsy of survivors performed: Yes
- Other examinations performed: Animals were observed for hair loss, skin coloration, oil on coat, diarrhoea, ataxia, and hyperactivity.
Statistics:
No data reported.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed.
Clinical signs:
Clinical signs observed during the study period included hypoactivity; ataxia ; diarrhoea; lacrimation; oily coat; yellow- or urine stained abdomen; hair loss on or around anus, abdomen and hindlegs.
Body weight:
Average body weights of the animals increased from pre-fasting to the terminal stage.
Gross pathology:
One male rat was found to have an enlarged renal pelvis. No other macroscopic lesions were found.

Any other information on results incl. tables

The study methods did not report if single animals are dosed in sequence, at 48 h intervals as stated in OECD Guidelines.

Reported deviations from protocol include: Water, purified by reverse osmosis, not tap water, was available ad libitum to the animals. The rats were fasted overnight for a period of approximately 19 hours prior to test material administration rather than 16 to 18 hours as stated in the protocol. These deviations are not considered to have had an effect on the validity of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information: LD50 greater than 5000 mg/kg bw
Conclusions:
The oral LD50 for straight run middle distillate in male and female rats was greater than 5000 mg/kg body weight.
Executive summary:

In an acute oral toxicity study, five male and five female fasted Sprague-Dawley, rats were given a single oral dose of a straight run middle distillate. The test substance was administered undiluted in a single gavage dose of 5000 mg/kg body weight. The animals were observed for 14 days.

Clinical signs observed during the study period included hypoactivity, ataxia, diarrhoea, lacrimation, oily yellow-stained coat, and hair loss. No mortality was observed. Body weights in both males and females had increased at day 7 and continued to increase at 14 days post-treatment.

The oral LD50 for straight run middle distillate in male and female rats was greater than 5000 mg/kg body weight.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD TG 401.