Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1980
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
publication
Title:
American Petroleum Institute (1980) Acute toxicity tests on API 79-6, diesel fuel (market place sample). Medical and Biological Sciences Dept. Report No. 27-32817
Author:
American Petroleum Institute
Year:
1980
Bibliographic source:
American Petroleum Institute

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
not specified
Principles of method if other than guideline:
Food was withheld from the rats overnight prior to dosing. A single dose of test material was given by gavage to groups of 5 male and 5 female rats at dose levels of 2.5, 5.0, 10, 15 & 20 ml/kg. Daily observations were made for death or signs of toxicity during the 14 day duration of the study. Body weights were recorded at the start and on the 7th and 14th day of the study.
A gross necropsy was performed on all animals that died during the study
and on all survivors that were sacrificed on day 14.
GLP compliance:
not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Doses:
2.5, 5.0, 10, 15 & 20 ml/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: oral median lethal dose
Effect level:
ca. 9 mL/kg bw
Based on:
not specified
95% CL:
>= 5.58 - <= 14.51

Any other information on results incl. tables

Mortality rates were as follows:

Dose group (ml/kg)  Mortality (%)
2.5 12.5
5 20
10 70
15 40
20 90

Signs of toxicity were the same for all dose groups and increased in severity with increasing dose. The signs included oily urine stains and oily diarrhea. The urine and feces stayed on the fur and caused hair loss, irritation, redness and sores on the affected skin. In many animal open sores were observed on the skin surrounding the anus. Blood around the eyes, nose and mouth was also common. Other signs noted included lethargy and pus or blood at the urinary orifice. Observations at gross necropsy were similar for each dose group. Almost all animals that died before the 14th day had intestinal damage. The intestines and often the stomach were hemorrhagic, sometimes observed with blood. The intestinal walls were thin. Test material was found in the cecum for many days after dosing and a few rats had white spots on their cecums and an increased amount of gas was noted in the intestinal tract. Animals surviving 14 days had fewer abnormalities, all minor in nature. These included enlarged Peyer's patches on the intestine, an indication that some irritation had occurred.

Applicant's summary and conclusion

Conclusions:
Although the study was conducted before Good Laboratory Practices were published, the study appears to have been conducted using appropriate methods and to have been fully reported.