Registration Dossier

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Four Sprague-Dawley derived Cox male rats were exposed to 1-NP vapors in a 360 liter air chamber for six hours at various concentrations of 1-NP. At the end of the six hour exposure time, the rats were sacrificed, the livers excised and the livers analyzed for 1-NP content.
GLP compliance:
no
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Commercial grade 1-Nitropropane

Test animals

Species:
rat
Strain:
other: Sprague-Dawley derived Cox rats
Sex:
male

Administration / exposure

Route of administration:
inhalation
Vehicle:
unchanged (no vehicle)
Details on exposure:
Rats were exposed to 1-NP vapors in a 360 liter air chamber for six hours at various concentrations of 1-NP. The chamber was controlled by rotameters and monitored with a Miran Infra-red Gas Analyzer. The flow rate was such that ten complete changes of air occurred each hour.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
The chamber was monitored with a Miran Infra-red Gas Analyzer.
Duration of treatment / exposure:
6 hours
Frequency of treatment:
Once
Post exposure period:
Some tests were made to determine the duration of 1-NP residue in the liver tissue of rats after exposure to 1200 ppm commercial grade 1-NP in an air inhalation chamber for 6 hours. The high level was chosen because 1200 ppm is near the LC 50 for 1-NP.
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1000, 1100, 1200 ppm
Basis:
nominal conc.
No. of animals per sex per dose:
4 males/exposure
Control animals:
yes, concurrent no treatment
Details on study design:
Some tests were made to determine the concentration of 1-nitropropane (1-NP) in the liver tissue of male rats after exposure to commercial grade 1-NP in an air inhalation chamber. Four Sprague-Dawley derived Cox male rats 160-180 grams of weight each, were exposed to 1-NP vapors in a 360 liter air chamber for six hours at various concentrations of 1-NP. The chamber was controlled by rotameters and monitored with a Miran Infra-red Gas Analyzer. The flow rate was such that ten complete changes of air occurred each hour. At the end of the six hour exposure time, the rats were sacrificed, the livers excised,and the livers analyzed for 1-NP content. The tissues were homogenized with sulfosalicylic acid to precipitate the protein and the homogenate was azeotropically distilled to remove the 1-NP from impurities. Two fractions of 5 ml each were collected. The fractions were analyzed for 1-NP by gas chromatography using a flame ionization detector.

Some tests were made to determine the duration of 1-NP residue in the liver tissue of rats after exposure to 1200 ppm commercial grade 1-NP in an air inhalation chamber for 6 hours. The high level was chosen because 1200 ppm is near the LC 50 for 1-NP.

Examinations

Examinations:
At the end of the six hour exposure time, the rats were sacrificed, the livers excised,and the livers analyzed for 1-NP content. The tissues were homogenized with sulfosalicylic acid to precipitate the protein and the homogenate was azeotropically distilled to remove the 1-NP from impurities. Two fractions of 5 rnl each were collected. The fractions were analyzed for 1-NP by gas chromatography using a flame ionization detector.

Results and discussion

Details on results:
The 1-NP content should increase as the level in the chamber increases. It is estimated that if 700 ppm or lower was used in the chamber, no 1-NP would accumulate in the liver.

The data indicate that after a 6 hour inhalation exposure to 1-NP at 1200 ppm, the liver accumulates 50 ppm 1-NP, The 1-NP increased at 2 hours, then began to decrease. It is estimated that the 1-NP would disappear after 8-10 hours.

Applicant's summary and conclusion

Conclusions:
The 1-NP content should increase as the level in the chamber increases. It is estimated that if 700 ppm or lower was used in the chamber, no 1-NP would accumulate in the liver. The data also indicate that after a 6 hour inhalation exposure to 1-NP at 1200 ppm, the liver accumulates 50 ppm 1-NP, The 1-NP increased at 2 hours, then began to decrease. It is estimated that the 1-NP would disappear after 8-10 hours.