2,2'-[ethane-1,2-diylbis(oxy)]bisethyl diacetate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance propane-1,2-diyl diacetate (CAS 623-84-7). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

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:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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

IUPAC Name:

propane-1,2-diyl diacetate

Details on test material:

- Name of test material (as cited in study report): Propylene Glycol Diacetate
- Analytical purity: 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 species. 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 129 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 et al. (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 ± 3 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

Effect levels 1

Sex:

male

Dose descriptor:

LC0

Effect level:

129 ppm

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: highest attainable concentration

Effect levels 2

Sex:

male

Dose descriptor:

LC0

Effect level:

0.845 mg/L air

Based on:

test mat.

Remarks on result:

other: corresponding to 129 ppm based on a molecular weight of 160.2 g/mol and a molar volume of 24.45 at 20 °C

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.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified