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Diss Factsheets

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
Study period:
circa 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to test guidelines and in accordance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
exposure was of 6 hour duration
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Propane-1,2-diyl diacetate
EC Number:
210-817-6
EC Name:
Propane-1,2-diyl diacetate
Cas Number:
623-84-7
Molecular formula:
C7H12O4
IUPAC Name:
propane-1,2-diyl diacetate
Details on test material:
GC analysis of the test material revealed a purity of 100 +/- 0.4%.

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male
Details on test animals or test system and environmental conditions:
Male Fischer 344 (F-344) rats, 6 - 8 weeks of age, were obtained from Charles River Breeding Laboratories, Inc., Kingston, NY. Selection of this species and strain was based on its hardiness, low incidence of respiratory disease and extensive historical data. Upon arrival at the laboratory, the rats were examined for health status by a qualified professional and acclimated to the laboratory for a minimum of two weeks prior to exposure. Animals were fed Purina Certified Rodent Chow #5002 (Ralston Purina Co., St. Louis, MO) and water ad libitum except during exposure. The rats were weighed, randomized by weight, and individually identified with a metal ear tag. Prior to and after exposure, the rats were placed in rooms designed to maintain
adequate environmental conditions concerning temperature and humidity specific for the specie. The animals were group housed prior to exposure
and singly housed during exposure and the two-week post-exposure period.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
Exposure Chambers.
Whole body exposures were conducted in 1 cubic meter stainless steel and glass Rochester-type chambers. Groups of six male rats were exposed to a targeted vapor concentration of 125 ppm, for six hours. This was the maximum practically attainable concentration of propylene glycol diacetate in the air.

The relative humidity value as well as maximum and minimum temperature values were recorded at the end of the exposure period.

Test Atmosphere.
The test atmosphere was generated by metering the liquid test substance at a calculated rate into a J-tube assembly as described by Miller -e t -a1 . (1980). Compressed air was heated with a flameless heat torch (Master FHT-4) to the minimum extent necessary to vaporize the test material. Air passing through the J-tube was diluted with the main chamber airstream prior to entering the chamber.

The concentration of PGDA in the exposure chamber was measured at least three times per hour by infrared spectrophotometry using a MIRAN IA
infrared gas analyzer at a wavelength of 8.2 um. Standards of known concentrations were prepared by vaporizing measured amounts of PGDA in
100 L Saran bags filled with a measured volume of filtered, dry air.

Standardization was checked prior to exposure with a standard of known concentration. The nominal concentration (ratio of the amount of PGDA
vaporized to the total amount of air through the chamber) was calculated for the 6 hour exposure period.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
6 h
Concentrations:
129 ppm
No. of animals per sex per dose:
6 male rats
Control animals:
no
Details on study design:
Animal Observations.
All rats were weighed and observed prior to exposure. All animals were observed a t least daily during the two-week post-exposure period for signs of exposure-related effects. Morning and week-end monitoring was limited to animal husbandry procedures required to ensure availability of feed and water. All rats were weighed on test day 1, 2, 5, 8, 12 and 15 and submitted for gross necropsy examination by a veterinary pathologist.
Statistics:
Mean and standard deviations of animal body weights were calculated for descriptive purposes.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC0
Effect level:
> 129 ppm
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: highest attainable concentration
Mortality:
All of the rats survived the 6 hour exposure period and the 14 day observation period.
Clinical signs:
other: During exposure, all rats appeared normal and no exposure-related effects were noted during the two-week post-exposure period.
Gross pathology:
Gross pathologic examination of the animals showed all within normal limits.
Other findings:
Animals were exposed to a TWA concentration of 129 +/- 3 ppm PGDA for six hours. This was a maximum practically attainable concentration of
propylene glycol diacetate in the air. The nominal concentration was 109 ppm. The reason for the difference between the nominal and analytical
values is not known. Total chamber airflow was 202 l/min.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortality was observed after 6 h exposure to 129 ppm PGDA which is the highest attainable concentration. Based on the results of this study, propylene glycol diacetate would not be expected to pose any significant acute inhalation hazards. Hence, no classification according to EU criteria is required.
Executive summary:

A group of six male rats was exposed for six hours to vapors of propylene glycol diacetate. The time-weighted-average (TWA) concentration during the exposure was measured to be 129 ppm, and was the highest practically attainable concentration.

After exposure, all rats appeared normal and all survived the two-week post-exposure period. Gross pathologic examination revealed no exposure-related effects. Based on this study, propylene glycol diacetate vapor would not be expected to pose any significant acute inhalation hazards.