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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study is comparable to the OECD Guideline 403 with acceptable restrictions (limited documentation of results; males and females used in the same dose group; partly limited documentation of methods, e.g. no details about the test substance; nominal concentrations).

Data source

Reference
Reference Type:
publication
Title:
The assay of acute vapor toxicity, and the grading and interpretation of results on 96 chemical compounds
Author:
Carpenter CP, Smyth HF, Pozzani UC
Year:
1949
Bibliographic source:
J Ind Hyg Toxicol 31: 343-346

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

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

Test animals

Species:
rat
Strain:
Sherman
Sex:
male/female
Details on test animals and environmental conditions:
Source: Mellon Institute, University of Pittsburgh, Pittsburgh, Pennsylvania
body weight 100 to 150 g
No further details

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
No analytical verification of the concentration. The concentration was based upon empirical calculations (generation in an evaporator; amount of dilution air measured). All-glass vessel used for exposure chamber.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
No details were given but it can be assumed that concentration below and above 32 ppm (see results) were also investigated; the following concentrations were reported in the result section for other test substances: 8, 16, 32, 62, 125 ppm.
No. of animals per sex per dose:
6 rats per dose level (males and females used, no details given)
Control animals:
not specified
Details on study design:
Concentration varied in a geometric progression increasing by a factor of 2 until the concentration which kills 2, 3, or 4 of 6 rats within a 14-day observation period; the exposure duration was constant in all experiments (4 h); during exposure first appearance of any abnormal symptoms was recorded and the time that has elapsed until their occurrence (check list used); autopsies performed on all of the rats; lung, liver, spleen, adrenal gland, kidney, and testis taken for histopathological examinations from 2 of the rats which died during the 14 day observation period and also from 2 that survived. The survivors were weighed.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: concentration resulting in lethal effects in 2-4 out of 6 treated rats
Effect level:
32 ppm
Exp. duration:
4 h
Mortality:
At a concentration of 32 ppm (107 mg/m³) and an exposure duration of 4 h 2-4 out of 6 rats died during the post exposure observation period of 14 days. No further details were given but it can be assumed that a concentration of 16 ppm resulted in no mortality or only 1 death in 6 treated rats and at a concentration of 62 ppm more than 4 out of 6 treated rats died.
Clinical signs:
other: No data reported in the result section.
Body weight:
No data reported in the result section.
Gross pathology:
No data reported in the result section.
Other findings:
no

Any other information on results incl. tables

In preliminary experiments 2 or more of 6 treated rats died after exposure to saturated vapour (room temperature) for 8 h; no further details available.

Compare these results with IHT studies (Section 7.2.2).

Applicant's summary and conclusion

Conclusions:
Rough estimation of LC50 (4 h) in rats: 16 ppm (53 mg/m³) < LC50 < 62 ppm (207 mg/m³)
Executive summary:

The study is comparable to the OECD Guideline 403 with acceptable restrictions (limited documentation of results; males and females used in the same dose group; partly limited documentation of methods, e.g. no details about the test substance; nominal concentrations).

Six Sherman rats per dose level were exposed for 4 hours to concentrations varied in a geometric progression increasing by a factor of 2. The post exposure observation period was 14 days. At a concentration of 32 ppm (107 mg/m³) 2 -4 out of 6 treated rats died. No further details were reported in the result section. However, it can be assumed that a concentration of 16 ppm resulted in no mortality or only 1 death in 6 treated rats and at a concentration of 62 ppm more than 4 out of 6 treated rats died.

Conclusion: Rough estimation of LC50 (4 h) in rats: 16 ppm (53 mg/m³) < LC50 < 62 ppm (207 mg/m³).