Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: This is a very old study, the concentration is not measured.

Data source

Reference
Reference Type:
publication
Title:
Range finding toxicity data, list III
Author:
Smyth HF, Carpenter CP, Weil CS
Year:
1949
Bibliographic source:
J Ind Hyg Tox 31: 60-61

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Determination of the time of death when animals are exposed to saturated vapor.
More details on the method are given in previous publications. These details have been added hereafter.
The publications are:
Smyth & Carpenter (1944): The place of the range-finding test in the industrial toxicology laboratory. J Ind Hyg Tox 26: 269-273
Smyth & Carpenter (1948): Further experience with the range finding test in the industrial toxicology laboratory. J Ind Hyg Tox 30: 63-68
GLP compliance:
no
Remarks:
Study made before the GLP creation
Test type:
other: Time of death, exposure to saturated vapor
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data

Test animals

Species:
rat
Strain:
other: albino, no further data
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: no data
Details on inhalation exposure:
No data
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
Saturated vapor, for the determination of time to death and then exposure to 250 or 500 ppm for 4 hours
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
Exposure to air substantially saturated with vapors prepared by passing the test substance through a fritted disc bubbler at room temperature for period of time falling in a geometric serie with a constant ratio of 2, up to eight hours.
Then exposure to 250 or 500 ppm for 4 hours.
Statistics:
no data

Results and discussion

Preliminary study:
No data
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
other: Maximum time for no death when exposed to saturated vapors
Effect level:
2 other: h
Sex:
male
Dose descriptor:
other: no mortality
Effect level:
250 ppm
Based on:
not specified
Exp. duration:
4 h
Sex:
male
Dose descriptor:
other: all animals died
Effect level:
500 ppm
Based on:
not specified
Exp. duration:
4 h
Mortality:
0/6 at 250 ppm for 4 hours and 6/6 at 500 ppm for 4 hours
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
500 ppm for 4 h is the LD100, 250 ppm is the LD0
Executive summary:

The acute inhalation toxicity has been determined in rats using the maximum time for no death upon exposure to saturated vapor.

The maximum time for no death is 2 h. Then 2 concentrations were tested for 4 h (250 and 500 ppm). No mortality is observed at 250 ppm while 500 ppm lead to 100% of mortality (6 males per group).