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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:
1990-08-05 to 1992-05-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was carried out according to EPA OTS 798.1175 and equivalent or similar to OECD TG 420.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: F-133, thermocracked kerosine, CAS No. 68333-23-3
- Substance type:
- Physical state: liquid
- Analytical purity: 100% petroleum hydrocarbons
- Storage condition of test material: test material was stored at temperature below 27 degrees Celsius
- pH: 5
- Density: 0.8965 g/ml
- Specific gravity: approximately 0.74
- Flash point: approximately -42 degree Celsius

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin & Kingman, Fremont, CA
- Age at study initiation: young adults (eight to twelve weeks old)
- Weight at study initiation: approximately 200 to 350 grams pre-fasting
- Fasting period before study: animals were not fed the night before dosing
- Housing: individually housed in stainless steel, wire mesh bottom cages
- Diet: fresh certified Agway rodent feed provided ad libitum, feed was withheld the night before dosing
- Water: fresh potable water was provided ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 26 degrees Celsius, within protocol limits
- Humidity (%): 40 to 70%, within protocol limits
- Air changes (per hr): no less than ten air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


IN-LIFE DATES: From: 1990-08-05 To: 1990-10-01

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other:
Details on oral exposure:
No vehicle, test substance was administered in undiluted form

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw


Doses:
5000 mg/kg bw
No. of animals per sex per dose:
five males and five females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: fourteen days
- Frequency of observations and weighing: animals were observed hourly for first four hours after dosing and twice daily for the following fourteen days; animals were weighed when acquired by the testing facility, prior to fasting, prior to test administration, and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, external evaluation at necropsy
Statistics:
The mean and standard deviation for body weight data were calculated

Results and discussion

Preliminary study:
The oral limit test resulted in no mortality at a dose level of 5000 mg/kg bw therefore, no further testing was done.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: Based on lack of mortality and systemic effects
Mortality:
No animals died during the testing period
Clinical signs:
All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia.
Body weight:
All animals gained weight during study period
Gross pathology:
At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions.

Any other information on results incl. tables

No mortalities in the study.
Clinical signs were:
 
nasal discharge in 1/10 animals - cleared by day 2
ocular discharge in 1/10 animals - cleared by day 2
Loose stools in 2/10 animals - cleared by day 2
Lethargy in 1/10 animals - cleared by day 2
Stained coat in 10/10 animals - cleared by day 4
Alopecia in 10/10 animals to 9/10 animals day 14.

All animals gained weight during the study.
There were no abnormalities at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for thermocracked kerosine is greater than 5000 mg/kg bw in Sprague Dawley rats under the conditions of this study.
Executive summary:

In an acute oral toxicity study, groups of fasted, young adult, Sprague Dawley rats, five male and five female, were given a single oral dose of undiluted thermocracked kerosine at a dose of 5000 mg/kg bw and observed for 14 days.

There were no treatment related mortalities. All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia. All animals gained weight during study period. At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions. The oral LD50 was determined to be greater than 5000 mg/kg in males and females.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was carried out according to EPA OTS 798.1175 and equivalent or similar to OECD TG 420.