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Acute Toxicity: inhalation

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acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed and documented in a robust manner (adopted from OECD SIDS)

Data source

Referenceopen allclose all

Reference Type:
secondary source
Reference Type:
No information
PPG Ind. Inc.
Bibliographic source:
TSCATS, OTS 0513463, Doc. I.D. 89-878000001

Materials and methods

Principles of method if other than guideline:
Acute inhalation toxicity study with rats (1 h).
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Details on test material:
Purity of test material was not analytically confirmed. It was used as received from PPG Industries. Purity of that material is listed as > 98% on the MSDS.

Test animals

Details on test animals and environmental conditions:
The animals (15 males and 20 females) were acclimated for at least one week before use. The males and females weighed 265-315 g and 198-246 g when tested, respectively. Food and water were available ad libitum (except during exposure). Animals were randomized to groups of 5 animals/sex.

Administration / exposure

Route of administration:
other: The test material was generated as an aerosol. However, the material the animals were exposed to may have been vapor indicated by the volatility of the material.
Type of inhalation exposure:
whole body
other: unchanged (no vehicle)
Details on inhalation exposure:
The aerosol was generated by pumping the test material through a pressure operated spray nozzle. The aerosol was diluted with dried, filtered air and drawn into the exposure chamber. Air flow into the chamber was maintained through the use of a calibrated critical orifice. Air flow was recorded at 30 min intervals during the exposure period. Air flow was sufficient to ensure adequate oxygenation of the exposure atmosphere. Temperature and humidity were recorded at 30 min intervals from a wet bulb/dry bulb hygrometer located in the exposure chamber.
The concentration of test material in atmosphere samples collected twice for each exposure (at 30 and 60 minutes) was determined analytically using a gas chromatograph. The nominal concentration was determined by dividing the loss in weight of the test material after exposure by the total volume of air that passed through the chamber. Due to the volatility of the test material, gravimetric and particle size determinations could not be performed.
Analytical verification of test atmosphere concentrations:
Duration of exposure:
1 h
0.834, 1.16, 1.23 (here only females were tested) and 1.47 mg/L (analytical; corresponding to 1.06, 1.91, 2.05 and 2.61 mg/L nominal)
Details on study design:
Animals were observed frequently on the day of exposure (4 animals per group) and at least once daily thereafter (all animals) for 14 days for signs of toxicity. Individual body weights were recorded just prior to exposure and on days 7 and 14 (or as soon as possible after death). Gross necropsies were performed on all animals upon euthanization on day 14 or as soon as possible after death.
The LD50 values were calculated by the method of Litchfield and Wilcoxon (J Pharm Ther 96:99-115, 1949).

Results and discussion

Effect levelsopen allclose all
Dose descriptor:
Effect level:
1.26 mg/L air
95% CL:
1.18 - 1.34
Exp. duration:
1 h
Dose descriptor:
Effect level:
1.13 mg/L air (analytical)
95% CL:
1.01 - 1.27
Exp. duration:
1 h
Dose descriptor:
Effect level:
1.34 mg/L air (analytical)
Exp. duration:
1 h
The number of deaths (and time of death) was as follows:
0.834 mg/l: 0/5 males, 0/5 females
1.116 mg/l: 3/5 males (2 hr to Day 1), 0/5 females
1.23 mg/l: 5/5 females (from 2 hr to Day 1)
1.47 mg l: 5/5 males and 5/5 females (from 2 hr to Day 1)
Clinical signs:
other: Signs observed over the course of the study were activity decrease, constricted pupils, dilated pupils, emaciation, epistaxis, gasping, lacrimation, nasal discharge, piloerection, polyuria, ptosis, respiratory gurgle, and/or salivation.
Body weight:
Thirteen (3 animals exposed to 0.834 mg/l, 6 animals exposed to 1.16 mg/l, and 4 animals exposed to 1.23 mg/l) of the 22 animals that survived for 14 days gained weight.
Gross pathology:
Gross necropsy findings in animals that died before and at study termination included emaciation, lacrimation, nasal discharge, polyuria, salivation,
discoloration of lungs and contents of the GI tract, lungs edematous, and/or GI tract distended with gas.
Discoloration of the lungs, lung distension and edema were observed at necropsy in 9/10 surviving animals exposed to 0.834 mg/l. No significant findings were noted in one female exposed to 0.834 mg/l and all survivors exposed to 1.16 or 1.23 mg/l.

Other findings:
The relative humidities and temperatures of all five chambers ranged from 60-77% and 21-23°C, respectively. The flow rates of all chambers were
maintained at 138.8 lpm (with the exception of the chamber containing 1.23 mg/l, which was 99.8 lpm).

Any other information on results incl. tables

The test material was generated as an aerosol. However, the material the animals were exposed to may have been vapor indicated by the volatility of the material. Particle
sizing was not attempted.

Applicant's summary and conclusion