Fuels, diesel

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restrictions because it is GLP compliant and was generally conducted according to OECD 403 guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

68334-30-5

Cas Number:

68334-30-5

IUPAC Name:

68334-30-5

Constituent 2

Reference substance name:

Naval distillate

IUPAC Name:

Naval distillate

Test material form:

other: low viscosity liquid hydrocarbon

Details on test material:

- Name of test material (as cited in study report): F-72-01
- Substance type: Petroleum product
- Physical state: Liquid
- Analytical purity: 100% Hydrocarbons
- Density: 0.8751 g/mL
- Lot/batch No.: 2045
- Stability under test conditions: 1 year
- Storage condition of test material: Room temperature

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 Laboratories, Inc., Kingston, New York 12484
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: 222 to 317 grams (males), 185 to 246 grams (females)
- Housing: Individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 to 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 °C
- Humidity (%): 24 to 91%
- Air changes (per hr): 23 to 28 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: March, 1986 To: June, 1986

Administration / exposure

Route of administration:

other: inhalation: aerosol and vapour mixture

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

Nominal concentrations of test article for each exposure determined gravimetrically. Analytical concentration determined using a gravimetric procedure for aerosol level and MIRAN for the vapour level. Actual exposure level is the sum of the aerosol and vapour level. Actual concentrations of the airborne test article measured near the breathing zone at one hour intervals during the exposure period. Particle size distribution measurements made near the breathing zone at one-hour intervals during the exposure period.

The Plexiglas exposure chamber had a total volume of 100L. The airflow rate (1pm) was 17.5, the air change (min) was 5.7 and the equilibrium time (min) was 26.3.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

2.3, 3.5, or 4.9 mg/L

No. of animals per sex per dose:

Ten

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily observations of test animals, weekly weighing of test animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LC50

Effect level:

3.6 mg/L air (analytical)

Exp. duration:

4 h

Effect levels 2

Sex:

male

Dose descriptor:

LC50

Effect level:

5.4 mg/L air (analytical)

Exp. duration:

4 h

Effect levels 3

Sex:

male/female

Dose descriptor:

LC50

Effect level:

4.1 mg/L air (analytical)

Exp. duration:

4 h

Mortality:

Mortality was seen at all doses, within three days following exposure. 11 animals died at the highest dose; 10 animals died at the middle dose; 1 animal died at the lowest dose.

Clinical signs:

other: Signs included labored breathing and gasping during exposure, which continued in the week following exposure, as well as reduced activity, eyes closed, oral and nasal discharge, and matted coats. All surviving animals were normal by day 15.

Body weight:

Body weight gain was decreased in all surviving animals, but values at day 15 generally indicated recovery from treatment.

Gross pathology:

Discoloration of lungs, red staining around snout on spontaneously dying animals.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The inhalation LC50 was determined to be 5.4 mg/L in males, 3.6 mg/L in females, and 4.1 mg/L in combined sexes. The test material is classified as harmful by inhalation according to EU criteria.

Executive summary:

In an acute inhalation toxicity study, groups of young adult Sprague-Dawley rats (10 per sex) were exposed by inhalation route to naval distillate for 4 hours at 2.3, 3.5, or 4.9 mg/L of aerosol. Animals then were observed for 14 days.

 

Animals had laboured breathing and nasal discharge, but survivors were normal by study termination. Following exposure, animals in all groups lost weight, but body weight at study termination indicated recovery. The inhalation LC50 was determined to be 5.4 mg/L in males, 3.6 mg/L in females, and 4.1 mg/L in combined sexes. The test material is classified as harmful by inhalation according to EU criteria.

 

This study received a Klimisch score of one and is classified as reliable without restrictions because the study was GLP compliant and was generally conducted according to OECD 403 guidelines.