Petroleum kerosene fraction, co-processed with renewable hydrocarbons of plant and/or animal origin

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

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 was carried out in a method equivalent/similar to OECD TG 403.

Justification for type of information:

Read across justification included in Section 13

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

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 was carried out in a method equivalent/similar to OECD TG 403.

Justification for type of information:

Read across justification included in Section 13

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

Exposure comprised of aerosol/vapour mixture.

Duration of exposure:

4 h

Concentrations:

Single 4 hour whole-body exposure to 5.2 mg/L

No. of animals per sex per dose:

Five

Control animals:

no

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.2 mg/L air

Exp. duration:

4 h

There were no mortalities during the study. The principal pharmacotoxic sign was dyspnoea which was observed on the day of exposure and for some animals up to 6 days after exposure. There was no effect on body weight gains and no treatment-related abnormalities were observed during necropsy or during the histopathological examination of the lungs and tracheas of the exposed animals.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LC50 was greater than 5.2 mg/L, the only dose tested.

Executive summary:

In an acute inhalation toxicity study, 5 male and 5 female albino Sprague-Dawley rats were exposed to an aerosol/vapour atmosphere of hydrodesulfurised kerosine for 4 hours at a concentration of 5.2 mg/L. All animals were observed during and after the exposure on the day of exposure and daily during a 14-day post-exposure observation period. Animal body weights were recorded just prior to exposure, on days 7 and 14 post-exposure and at death. At termination of the study, all animals were sacrificed and subjected to complete necropsy. Lungs and trachea were evaluated histopathologically. Dyspnea was the principal sign observed on the day of exposure and during the post-exposure period, with matted fur being a result of the aerosol exposure. There were no deaths during the study and no apparent exposure-related effects on the bodyweights. No exposure related histopathological changes were observed. The LC50 was greater than 5.2 mg/L. The test material is not classified according to EU criteria based on no upper limit for the LC50.

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

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

Test material

Test material information

Constituent 1

Reference substance name:

Kerosine (petroleum), hydrodesulfurized

EC Number:

265-184-9

EC Name:

Kerosine (petroleum), hydrodesulfurized

Cas Number:

64742-81-0

IUPAC Name:

Kerosine (petroleum), hydrodesulfurized

Constituent 2

Reference substance name:

Hydrodesulfurised kerosine

IUPAC Name:

Hydrodesulfurised kerosine

Test material form:

other: low viscosity liquid hydrocarbon

Details on test material:

- Name of test material (as cited in study report): Hydrodesulfurised kerosine, CAS 64742-81-0
- Lot/batch No.: API 81-07

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

Exposure comprised of aerosol/vapour mixture.

Duration of exposure:

4 h

Concentrations:

Single 4 hour whole-body exposure to 5.2 mg/L

No. of animals per sex per dose:

Five

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.2 mg/L air

Exp. duration:

4 h

Any other information on results incl. tables

There were no mortalities during the study. The principal pharmacotoxic sign was dyspnoea which was observed on the day of exposure and for some animals up to 6 days after exposure. There was no effect on body weight gains and no treatment-related abnormalities were observed during necropsy or during the histopathological examination of the lungs and tracheas of the exposed animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LC50 was greater than 5.2 mg/L, the only dose tested.

Executive summary:

In an acute inhalation toxicity study, 5 male and 5 female albino Sprague-Dawley rats were exposed to an aerosol/vapour atmosphere of hydrodesulfurised kerosine for 4 hours at a concentration of 5.2 mg/L. All animals were observed during and after the exposure on the day of exposure and daily during a 14-day post-exposure observation period. Animal body weights were recorded just prior to exposure, on days 7 and 14 post-exposure and at death. At termination of the study, all animals were sacrificed and subjected to complete necropsy. Lungs and trachea were evaluated histopathologically. Dyspnea was the principal sign observed on the day of exposure and during the post-exposure period, with matted fur being a result of the aerosol exposure. There were no deaths during the study and no apparent exposure-related effects on the bodyweights. No exposure related histopathological changes were observed. The LC50 was greater than 5.2 mg/L. The test material is not classified according to EU criteria based on no upper limit for the LC50.

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