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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
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:
read-across: supporting information
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
read-across based on grouping of substances (category approach)
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.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
no data
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.
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:
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:

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

Referenceopen allclose all

Reference Type:
other: HPV Robust Summary
Title:
Unnamed
Year:
2003
Report Date:
2003
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
straight run kerosene

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
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.