Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1948-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented and scientifically accpetable. Study conducted before the advent of GLP.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1948
Report Date:
1948

Materials and methods

Principles of method if other than guideline:
Inhalation of saturated vapor by 6 rats for 8 hours.
Inhalation of a cooled mist generated by heating compound to 170°C while air was bubbled through it.
The vapor pressure is 0.3 mm at 20°C and air saturated at this temperature would contain on the order of 400 ppm.
GLP compliance:
no
Remarks:
Conducted before the advent of GLP.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
No additional details on test material

Test animals

Species:
rat
Strain:
other: Albino
Sex:
male
Details on test animals and environmental conditions:
No additional details on test aminals and environmental conditions..

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
A group of six albino rats were exposed to of saturated vapor produced at room temperature for 8-hours. Similarly, a group of six albino rats were exposed to a a cooled mist produced by heating the compound to 170°C. while air was bubbled through for 8-hours..
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
ca. 8 h
Concentrations:
For the vapor dose, vapor pressure is 0.3 mm. at 20°C. and air saturated at this temperature would contain on the order of 400 ppm.
For the mist dose, cooled mist produced by heating the compound to 170°C. while air was bubbled through.
No. of animals per sex per dose:
6 rats per 8 hour vapor dose and
6 rats per 8 hour mist dose
Control animals:
no
Details on study design:
No additional details on the study design.
Statistics:
No additional details on statistics.

Results and discussion

Preliminary study:
No preliminary study data.
Effect levels
Sex:
male
Dose descriptor:
LC0
Effect level:
ca. 400 ppm
Based on:
other: vapor pressure
Exp. duration:
8 h
Mortality:
No deaths after 8 hour exposure.
Clinical signs:
N/A
Body weight:
N/A
Gross pathology:
N/A
Other findings:
N/A

Any other information on results incl. tables

No additional results or table.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Neither air saturated at room temperature nor a mist produced by heating the compound to 170°C, while aerated, killed rates in an 8-hour
exposure. The Vapor hazard is therefore low.
Executive summary:

Neither air staurated at room temperature nor a mist produced by heating the compound to 170oC while aerated, killed rats in an

8-hour exposure. Vapor hazard is therefore low.