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Acute Toxicity: inhalation

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acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1986-05-30 to 1987-01-01
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was carried out in a method similar/equivalent to OECD TG 403.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
Test type:
fixed concentration procedure

Test material

Constituent 1
Reference substance name:
Cas Number:
Constituent 2
Reference substance name:
straight run kerosine
straight run kerosine
Test material form:
other: low viscosity liquid hydrocarbon
Details on test material:
- Name of test material: straight run kerosine, petroleum derived hydrocarbon, CAS No. 8008-20-6
- Substance type: complex combination of hydrocarbons produced by the distillation of crude oil
- Physical state: liquid
- Analytical purity: not applicable, complex hydrocarbon mixture
- Composition of test material, percentage of components: 2.5% olefins, 15.5% aromatics, 82% saturates
- Lot/batch No.: indefinite
- Stability under test conditions: indefinite under prescribed storage conditions
- Storage condition of test material: refrigerated at approximately 4 degrees celsius
- Supplier: American Petroleum Institute

Test animals

Details on test animals or test system and environmental conditions:
- Source: Charles River Laboratories, Inc. Kingston, New York
- Age at study initiation: 6 to 10 days
- Weight at study initiation: males range from 311.0 to 365.5 grams; females range from 216.9 to 236.1 grams
- Housing: animals were house individually in hanging steel wire mesh cages
- Diet: during non-exposure periods-Purina Certified Laboratory Chow 5002, ad libitum; during exposure periods- none
- Water: during non-exposure periods- tap water, ad libitum; during exposure periods- none
- Acclimation period: no data reported

- Temperature (°C): 22 to 24°C
- Humidity (%): 43 to 54%
- Air changes (per hr): no data reported
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

IN-LIFE DATES: From: 1986-03-24 (males); 1986-03-20 (females) To: 1986-06-13 (both males and females)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Details on inhalation exposure:
- Exposure apparatus: stainless steel and glass chamber
- Exposure chamber volume: 250 litres
- Total air flow: 2.2 cubic feet per minute
- Temperature, humidity, pressure in air chamber: test substance was introduced in a vertical counter column heated to approximately 50 degrees celsius

- Brief description of analytical method used: the test atmosphere was analyzed by a Miran 980 infrared (IR) analyzer at intervals of five to fifteen minutes after testing commenced. The test atmosphere was analyzed gravimetrically and visually (via flashlight) for aerosols . Gravimetric measurements were generated by drawing a calibrated volume of the test atmosphere through a preweighted 25 mm Gelman Metricel filter and dividing the difference in filter weight by the sample volume. Components of the generation system and test container were weighed before and after the exposure to determined the quantity of test material consumed. The quality was divided by the total air flow through the chamber to determine the nominal exposure concentration

- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:
Duration of exposure:
<= 4 h
mean analytical concentration of 5.28 mg/L petroleum derived hydrocarbon
No. of animals per sex per dose:
five animals per sex were exposed
Control animals:
not specified
Details on study design:
Five animals per sex were exposed to 5.28 mg/L of the test substance during a single 4 hour whole body inhalation exposure. Animals were introduced to the test substance in a 250 litre stainless steel and glass chamber. Total airflow through the chamber was 2.2 cubic feet per minute. API 83-09 was generated as a vapour and flowed into the chamber at a rate of 0.34 to 0.51 ml/minute from the top of a vertical counter current heated column. Prewarmed nitrogen was introduced from the bottom of the column at a rate of 7.0 L/minute. The nitrogen and test substances were mixed with air before introduction into the chamber. After 4 hours of exposure the test material generation system was turned off and residue cleared. Test animals were removed from the testing chamber and observed for fourteen days post exposure. Surviving animals were sacrificed and a gross post-mortem examinations were preformed.
The mean analytical exposure values were calculated, along with the nominal-to-analytical ratio.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 5.28 mg/L air (analytical)
95% CL:
Exp. duration:
4 h
Remarks on result:
other: Based on lack of mortality and systemic effects
No test animals died during exposure or the post-exposure observation period.
Clinical signs:
other: Rats were monitored for decreased activity, soft feces, coat consistency and colour, squinted eyes, and body weight. All animals exhibited decreased activity during the third and fourth hour of exposure and on the second and third days following exposure
Body weight:
On day eight of the study, one male rat's body weight was recorded as less than his pre-exposure body weight. By test day fifteen, it was back to normal. No significant changes in body weights were noticed, for any other test animal, throughout the study.
Gross pathology:
During gross pathology observations, four sections of the lung were examined. The pathology report indicated that no significant histological alternations were seen.

Any other information on results incl. tables

All animals survived the study. Physical examination, body weight observations, and gross post-mortem and histopathological results were considered insignificant.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
Based on zero mortality and absence of significant toxicity, body weight observations, and gross post-mortem and histopathological results, in the lungs, it is concluded that straight run kerosine does not have acute toxic effects under the conditions of this study.
Executive summary:

In an acute inhalation toxicity study, groups of Sprague-Dawley rats, five males and five females, were exposed by inhalation route to a petroleum derived hydrocarbon for 4 hours to their whole body at a single dose of 5.28 mg/L. Animals were then observed for 14 days afterwards.

All animals survived the study. Physical examination, gross port-mortem and histopathological results were considered insignificant. One male rat's body weight was recorded as less than his pre-exposure body weight during post-exposure examinations, but returned to normal before being sacrificed. No significant changes in body weights were noticed, for any other test animal, throughout the study. The analytical NOAEC for this study is >5.28 mg/L air. The test material is not classified according to EU criteria due to no upper limit of the NOAEC.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was carried out in a method similar/equivalent to OECD TG 403.