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Acute Toxicity: inhalation

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acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Non-GLP study which seems to be well performed. However, the results are not well described with no details given on the substance.

Data source

Reference Type:
The assay of acute vapor toxicity, and the grading and interpretation of results on 96 chemical compounds.
Carpenter CP, Smyth HF, Pozzani UC
Bibliographic source:
J. Ind. Hyg. Toxicol. vol. 31 no. 6, pp. 343-346

Materials and methods

Test guideline
no guideline followed
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Reference substance name:
Details on test material:
No details presented.

Test animals

Details on test animals or test system and environmental conditions:
Body weight: 100-150 g

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Details on inhalation exposure:
The vapour concentration is prepared by delivering the fluid sample, from a 10 ml hypodermic syringe activated by a "Monodrum", through a 26-gauge 6-inch hypodermic needle into an evaporator through which metered air is forced. The rats are exposed to the vapour-air mixture which flows through a 9-liter desiccator fitted with inlet and outlet ports built in a standard taper stopper. The rate of flow of dilution air is measured by a "Rotameter" covering a range of 0.5-30 L/min. The vapours are carried to the all-glass exposure chamber by the counter current of dilution air entering the bottom of the evaporator.
Analytical verification of test atmosphere concentrations:
Duration of exposure:
4 h
8 ppm, 16 ppm, 32 ppm, 62 ppm, 125 ppm.
The concentration is based upon empirical calculation. Experience indicates that the calculated concentrations are slightly higher than would actually be found if it were practical to determine them analytically on the exposure air.
No. of animals per sex per dose:
6 animals (sex unknown)
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations during 4-hour exposure. Body weight of survivors at the end of the study and of all animals at start of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology, histopathology on lung, liver, spleen, adrenal gland, kidney and testis from 2 dead and 2 surviving animals (after 14 d).
no data.

Results and discussion

Preliminary study:
Screening test: exposure of 6 rats for 8 h to substantially saturated vapour generated at room temperature. No details on results given.
At 125 ppm, 2/6, 3/6 or 4/6 rats died within the 14 day period.
At 62 ppm and below, 1/6 or 0/6 died within the 14 day period.
Clinical signs:
other: no details.
Body weight:
no details.
Gross pathology:
no details.
Other findings:
The range belonging to the exposure concentration of 125 ppm (the dose at which 2, 3, or 4 of 6 rats died within 14 days) is 88-174 ppm.

Any other information on results incl. tables

No further details given.

Formula used to calculate the concentration in mg/m3: concentration in mg/m3 = concentration in ppm x molecular weight / molar volume, with molecular weight = 110.54 g/mol and molar volume = 24.45 L/mol.

Applicant's summary and conclusion

Interpretation of results:
Migrated information Criteria used for interpretation of results: EU
At 125 ppm (i.e. ca. 0.57 mg/L) 2, 3, or 4 of 6 rats died within 14 days. At 62 ppm (i.e. ca. 0.28 mg/L) 1 or 0 of 6 rats died). At 250 ppm (i.e. ca. 1.13 mg/L) more than 4/6 rats died. It can be concluded that the LC50 lies between 0.28 and 1.13 mg/L.

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