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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:
2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted using basic scientific principles. Summary is from published literature.
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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted using basic scientific principles. Summary is from published literature.
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)
Deviations:
yes
Remarks:
8 hour exposure
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male
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)
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
0.27, 0.45, 0.79, 1.9, 2.4, 4.6, 8.2 mg/L; 8.2 mg/L; 8.2 mg/L = 1400ppm
No. of animals per sex per dose:
15 animals
Control animals:
yes
Details on study design:
Groups of 15 young male rats inhaled various concentrations, to provide a lethal and a no-ill-effect level for single 8-hr periods. Ten of the fifteen animals were randomly selected for the determination of the lethal and the no-ill-effect levels, based upon a 14-day observation period, and five for gross autopsy and histopathological evaluation immediately following the exposure.
Statistics:
no data
Key result
Sex:
male
Dose descriptor:
LC50
Effect level:
> 8.2 mg/L air (nominal)
Remarks on result:
other: 1400 ppm; 1 animal died at this exposure
Mortality:
1 animal died at the 8.2 mg/L exposure
Clinical signs:
other: Their response at this concentration included eye irritation, bloody exudate around the nostrils, and slight loss of coordination. When rats inhaled a measured 4.6 mg/liter (800 ppm), they showed similar signs but no loss of coordination. Inhalation of 2.
Body weight:
Weight changes at the 4.6 and 8.2 mg/L doses. No effects at 2.4 mg/L.
Gross pathology:
no data
Other findings:
none
Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
LC50 (4- to 8-h exposures) in rats for mineral spirits is greater than 8.2 mg/L
Executive summary:

Groups of 15 young male rats inhaled various concentrations, to provide a lethal and a no-ill-effect level for single 8-hr periods. Ten of the fifteen animals were randomly selected for the determination of the lethal and the no-ill-effect levels, based upon a 14-day observation period, and five for gross autopsy and histopathological evaluation immediately following the exposure. The LC50 >8.2 mg/liter (1400 ppm), which was maximum concentration attained under the test system conditions.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Review of the toxicology of mineral spirits
Author:
Amoruso M.A., Gamble J.F., McKee R.H., Rohde A.M.
Year:
2008
Bibliographic source:
International Journal of Toxicology 27: 97–165
Reference Type:
publication
Title:
Petroleum hydrocarbon toxicity studies. Ill. Animal and human response to vapors of Stoddard Solvent
Author:
Carpenter C.P., Kinkead E.R., Geary Jr. D.L., Sulivan L.J., King J.M.
Year:
1975
Bibliographic source:
Toxicology and Applied Pharmacology 32: 282-297

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
8 hour exposure
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Mineral Spirits

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
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)
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
0.27, 0.45, 0.79, 1.9, 2.4, 4.6, 8.2 mg/L; 8.2 mg/L; 8.2 mg/L = 1400ppm
No. of animals per sex per dose:
15 animals
Control animals:
yes
Details on study design:
Groups of 15 young male rats inhaled various concentrations, to provide a lethal and a no-ill-effect level for single 8-hr periods. Ten of the fifteen animals were randomly selected for the determination of the lethal and the no-ill-effect levels, based upon a 14-day observation period, and five for gross autopsy and histopathological evaluation immediately following the exposure.
Statistics:
no data

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LC50
Effect level:
> 8.2 mg/L air (nominal)
Remarks on result:
other: 1400 ppm; 1 animal died at this exposure
Mortality:
1 animal died at the 8.2 mg/L exposure
Clinical signs:
other: Their response at this concentration included eye irritation, bloody exudate around the nostrils, and slight loss of coordination. When rats inhaled a measured 4.6 mg/liter (800 ppm), they showed similar signs but no loss of coordination. Inhalation of 2.
Body weight:
Weight changes at the 4.6 and 8.2 mg/L doses. No effects at 2.4 mg/L.
Gross pathology:
no data
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
LC50 (4- to 8-h exposures) in rats for mineral spirits is greater than 8.2 mg/L
Executive summary:

Groups of 15 young male rats inhaled various concentrations, to provide a lethal and a no-ill-effect level for single 8-hr periods. Ten of the fifteen animals were randomly selected for the determination of the lethal and the no-ill-effect levels, based upon a 14-day observation period, and five for gross autopsy and histopathological evaluation immediately following the exposure. The LC50 >8.2 mg/liter (1400 ppm), which was maximum concentration attained under the test system conditions.