Reaction mass of 2,2'-(Ethylenedioxy)diethanol and 3,6,9-Trioxaundecane-1,11-diol

Acute Toxicity: inhalation

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Followed the specific protocol and standard protocol amendment by the Bushy Run Research Center. Five Sprague-Dawley rats per sex per dose were exposed to the aerolised test substance via a whole body inhalation system. They were exposed to a dose of 5.2 mg/L air for 4 hours. After an observation period of 14 days animals wer necropsied.

GLP compliance:

yes (incl. QA statement)

Test type:

traditional method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-(ethylenedioxy)diethanol

EC Number:

203-953-2

EC Name:

2,2'-(ethylenedioxy)diethanol

Cas Number:

112-27-6

Molecular formula:

C6H14O4

IUPAC Name:

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

Test material form:

liquid

Specific details on test material used for the study:

- Source: Union Carbide Chemicals and Plastics Company Inc., Texas City, TX
- Purity: ≥ 99.7%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague-Dawley Inc., Indianapolis, IN
- Housing: Rats were housed 5 per sex in stainless steel, wire-mesh cages in 2 rooms for the prestudy quarantine and postexposure periods, respectively. During exposure, rats were housed individually in 21 x 12.5 x 18 cm wire-mesh cages and exposed in a 1300-liter Plexiglas and stainless steel chamber
- Diet: Pelletal feed (Pro Lab RMH #3000, Agway, Inc.), ad libitum, except during exposure
- Water: tap water, ad libitum, except during exposure

ENVIRONMENTAL CONDITIONS
- Temperature: 19-23 °C
- Humidity: 40-56%
- Photoperiod: 12/12 h

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

5.54 µm

Geometric standard deviation (GSD):

2.71

Remark on MMAD/GSD:

MMAD 95% confidence interval were 4.72 - 6.50 µm

Details on inhalation exposure:

The test substance was metered from a piston pump (Fluid Metering Inc., Oyster Bay, NY) into an atomizer (Spraying Systems Co., Wheaton, IL) fitted with a No. 1650 liquid nozzle and a No. 64 air nozzle. The atomizer was positioned in the top of the inhalation chamber turret where the liquid diluted to the desired concentration and dispersed throughout the chamber by filtered supply air.
The target concentration for the exposure was 5 mg/L, based on the guidelines for "limit" testing met forth by the Toxic Substances Control Act (TSCA). A particle size lower than an MMAD of 5.3 µm could not be produced without greatly reducing the aerosol concentration of the test substance.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5.2 mg/L air

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Animals were observed for signs of toxic effects on the day of exposure and daily following exposure. The animals were weighed prior to exposure and postexposure Days 7 and 14. The change in body weight was calculated by subtracting the pre-exposure values from each successive weight. A complete necropsy was performed for all animals. The survivors were anaesthesized with methoxyflurane and killed by exsanguination via the brachial blood vessels. No tissues were saved.

Statistics:

The mean and standard deviation of the body weights, body weight changes, and exposure concentrations were calculated. No statistical comparisons were made.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.2 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality was observed.

Clinical signs:

other: Periocular wetness, blepharospasm wet (oily fur), absence of toe and tail pinch reflexes. Unkempt fur was the only sign observed during the post-exposure period.

Gross pathology:

No macroscopic lesions were observed in animals sacrificed at the end of the 2-week post-exposure period.

Any other information on results incl. tables

A mean (+/- SD) of the test substance concentration of 5.23 (±0.15) mg/L was obtained. The nominal concentration was 19.3 mg/L.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met