Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, aromatics (2-30 %)

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

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Equivalent or similar to OECD Guideline 403.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID 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

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Equivalent or similar to OECD Guideline 403.

Justification for type of information:

The justification for read across is provided as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across source

Preliminary study:

All except one animal had normal growth rates throughout the study. The one exception on day 8 had a body weight less than its starting body weight but by the end of the study normal growth had resumed. Decreased activity was exhibited by all animals during the exposure. Otherwise there were no treatment-related clinical signs of toxicity. No macroscopic lesions were observed in any animal at post-mortem and no microscopic changes were observed in any lung section examined.

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.28 mg/L air (analytical)

Exp. duration:

4 h

Mortality:

None

Clinical signs:

other: Decreased activity was exhibited by all animals during the exposure.

Body weight:

All except one animal had normal growth rates throughout the study. The one exception on day 8 had a body weight less than its starting body weight but by the end of the study normal growth had resumed.

Gross pathology:

No macroscopic lesions were observed in any animal at post-mortem and no microscopic changes were observed in any lung section examined.

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Classification as an inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

This data is being read across from the source study that tested Kerosene based on analogue read across.

The LC50 was >5.28 mg/L. Classification as an inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Reference 2

Reference Type:

other: HPV Robust Summary

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Straight run kerosene

IUPAC Name:

Straight run kerosene

Constituent 2

Reference substance name:

Kerosine (petroleum)

EC Number:

232-366-4

EC Name:

Kerosine (petroleum)

Cas Number:

8008-20-6

IUPAC Name:

Kerosine (petroleum)

Details on test material:

straight run kerosene

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

Exposure of the animals was conducted in a 250 liter stainless steel and glass chamber. The test material was introduced at a rate of 0.34 to 0.51 ml/minute into the top of a vertical counter current column that was packed with steel mesh and heated to approximately 50 °C. Pre-warmed nitrogen gas was introduced at the bottom of the column at a rate of 7 liters/minute. The nitrogen and test material vapors were then mixed with air and introduced into the exposure chamber. The test atmosphere was analyzed by IR every 15 minutes throughout the exposure. During each hour of the exposure, the test atmosphere was analyzed gravimetrically and visually (by flashlight) for aerosols of the test material. Test material consumption was determined by weighing the test material container before and after exposure. The quantity consumed was divided by the total airflow and this yielded the nominal exposure concentration. The mean exposure concentrations were: Nominal concentration 5.74 mg/l Analytical concentration 5.28 ±0.42 mg/l Gravimetric samples, collected on membrane filters, and aerosol checks with a flashlight showed some aerosol in the chamber. The nominal to analytical ratio and the gravimetric results both suggest the level of aerosol compared to level of vapor was insignificant in the exposure.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

5.28 +/- 0.42 mg/l

Duration of exposure:

4 h

Concentrations:

5.28 +/- 0.42 mg/l

No. of animals per sex per dose:

Five male and five female Sprague-Dawley rats were exposed to approximately 5 mg/l of test material as a single four-hour whole body exposure.

Details on study design:

Five male and five female Sprague-Dawley rats were exposed to approximately 5 mg/l of test material as a single four-hour whole body inhalation exposure. After the exposure the rats were kept for a 14 day observation period. Surviving animals at 14 days were sacrificed and subjected to a gross post-mortem examination. Records were made of any observed gross abnormalities. The lungs of all animals were preserved in formalin, sectioned and stained and then subjected to microscopic examination. No animals died following the exposure.

Results and discussion

Preliminary study:

All except one animal had normal growth rates throughout the study. The one exception on day 8 had a body weight less than its starting body weight but by the end of the study normal growth had resumed. Decreased activity was exhibited by all animals during the exposure. Otherwise there were no treatment-related clinical signs of toxicity. No macroscopic lesions were observed in any animal at post-mortem and no microscopic changes were observed in any lung section examined.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.28 mg/L air (analytical)

Exp. duration:

4 h

Mortality:

None

Clinical signs:

other: Decreased activity was exhibited by all animals during the exposure.

Body weight:

All except one animal had normal growth rates throughout the study. The one exception on day 8 had a body weight less than its starting body weight but by the end of the study normal growth had resumed.

Gross pathology:

No macroscopic lesions were observed in any animal at post-mortem and no microscopic changes were observed in any lung section examined.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Classification as an inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

The LC50 was >5.28 mg/L. Classification as an inhalation toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.