Middle distillate from refinery proces cofeeding vegetable oil

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979-04-11 to 1979-06-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

#2 home heating oil (50% catalytically-cracked)

IUPAC Name:

#2 home heating oil (50% catalytically-cracked)

Details on test material:

- Name of test material (as cited in study report): API #78-4, #2 home heating oil (50% cat)
- Substance type: petroleum distillation product composed of hydrocarbon chains
- Physical state: liquid
- Analytical purity: not provided by sponser
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: 50% virgin gas oil and 50% cracked gas oil
- Isomers composition: not reported
- Purity test date: no provided by sponser
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
- Stability under test conditions: nor provided by sponser
- Storage condition of test material: stored in Elars' test material storage room

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 Laboratories
- Age at study initiation: young adults
- Weight at study initiation: 200 to 400 grams
- Fasting period before study: feed was withheld overnight prior to dosing
- Housing: animals were housed individually in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: two weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported


IN-LIFE DATES: not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: no vehicle reported
- Amount of vehicle (if gavage): no vehicle reported
- Justification for choice of vehicle: not vehicle reported
- Lot/batch no. (if required): no vehicle reported
- Purity: no vehicle reported


MAXIMUM DOSE VOLUME APPLIED: 25 mL/kg


DOSAGE PREPARATION (if unusual): not reported

Doses:

10 mL/kg, 20 mL/kg, 22.5 mL/kg, 23 mL/kg, or 25 mL/kg body weight

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: daily for 14 days
- Frequency of observations and weighing: days 0 and 7, and terminal weights were taken
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

21.1 mL/kg bw

95% CL:

>= 18.7 - <= 24.9

Remarks on result:

other: approx 17,900 mg/kg bw

Mortality:

Mortality rates of the five dose groups (10, 20, 22,5, 23, and 25 mL/kg) were 0, 30, 70, 80, and 70% respectively.

Clinical signs:

other: Signs of toxicity were observed in all dose groups. Severity increased with increased dose. Common observations were oily urine stains on fur, which resulted in hair loss, irritation, redness, and sores. In higher doses the affected area included the enti

Gross pathology:

Gross pathology observations were also similar in each dose group. In rats who survived for the duration of the study (14 days), there were few abnormalities. In these rats minor observations include enlarged Peyer's patches on intestines. Both animals that died and survived exhibited mild irritation and congestion in the lungs, in addition to fluid-filled abscesses in the lungs. Investigators also observed enlarged adrenal glands of some animals. The majority of the animals that died before day 14 showed intestinal damage including, hemorrhaging, thinning of intestinal walls, and increased gas in the gastrointestinal tract.

Any other information on results incl. tables

Mortality Data
Dose	Mortality before Day 14
10 mL/kg	0
20 mL/kg	3
22.5 mL/kg	7
23 mL/kg	8
25 mL/kg	7

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study, the test material had an oral LD50 of 21.2 mL/kg (approx 17,900 mg/kg). The test material was determined to have a median lethal dose according to the study report. Under the conditions of this test, #2 home heating oil is considerede not classified for acute oral toxicity.

Executive summary:

In an acute oral toxicity study, five groups of ten rats (5 males and 5 females) were given a single dose of the appropriate amount of #2 home heating oil (50% catalytically-cracked) (10, 20 mL/kg, 22.5, 23, or 25 mL/kg) via oral gavage. Dose levels were chosen to produce expected mortality rates between 10 and 90%. Signs of mortality and toxicity were observed daily for the duration of the study (14 days). Body weight was measured on days 0 and 7, and upon death. Gross necropsy was performed on each animal when they died or by day 14.

Mortality rates of the five dose groups (10, 20, 22,5, 23, and 25 mL/kg) were 0, 30, 70, 80, and 70% respectively. Signs of toxicity were observed in all dose groups. Severity increased with increased dose. Common observations were oily urine stains on fur, which resulted in hair loss, irritation, redness, and sores. In higher doses the affected area included the entire ventral side and legs. Other observations included blood around eyes, nose, and mouth, lethargy and diarrhea. Gross pathology observations were also similar in each dose group. In rats who survived for the duration of the study (14 days), there were few abnormalities. In these rats minor observations included enlarged Peyer's patches on intestines. Both animals that died and survived exhibited mild irritation and congestion in the lungs, in addition to fluid-filled abscesses in the lungs. Investigators also observed enlarged adrenal glands of some animals. The majority of the animals that died before day 14 showed intestinal damage including, hemorrhaging, thinning of intestinal walls, and increased gas in the gastrointestinal tract.

Under the conditions of this study, the test material had an oral LD50 of 21.2 mL/kg (approx 17,900 mg/kg) and a 95% confidence interval of 18.7 and 24.9 mL/kg. the test material was determined to have a median lethal dose according to the study report. Under the conditions of this test, #2 home heating oil is considered not classified for acute oral toxicity.

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