Reaction mass of 2,2'-(ethylenedioxy)diethanol and 3,6,9,12,15-pentaoxaheptadecane-1,17-diol and 3,6,9,12-tetraoxatetradecane-1,14-d

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: acceptable, well-documented publication which meets basic scientific principles

Justification for type of information:

Read across is based on the category approach. Please refer to attached category document.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Materials and methods

Principles of method if other than guideline:

Followed the specific protocol and standard protocol amendment prepared by the Bushy Run Research Center.

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test type:

acute toxic class method

Limit test:

no

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

Details on test material:

purity: 99.7%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The rats were assigned unique identification numbers by ear tags and were housed 5 per sex in stainless steel, wire-meah cages in 2 rooms for the prestudy quarantine and postexposure periods, respectively. The rats were kept on a 12-hour photoperiod throughout the entire study. Pelletal feed and tap water were available ad libitum except during exposure.
TEG was metered from a platon pump into an atomizer fitted with liquid nozzle and a No. 64 air nozzle.
The atomizer was positioned in the top of the inhalation chamber turret where the liquid aerosol was 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 set forth by the Toxic Substances Control Act (TSCA).
The concentration of TEG in the chamber was measured approximately every 30 minutes.
The nominal concentration was determined by dividing the weight of the test substance delivered by the volume of air which passed through the chamber during the exposure period.
The temperature and relative humidity in the animal housing room were recorded continuously with a 7-day recording hygrothermograph.
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 on post-exposure days 7 and 14.
A complete necropsy was performed for all animals.

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: no data

Duration of exposure:

4 h

Concentrations:

5.2 mg/l

No. of animals per sex per dose:

5

Control animals:

no

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

Exp. duration:

4 h

Remarks on result:

other: No mortalities.

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) TEG 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:

Category 5 based on GHS criteria

Conclusions:

The results of this study indicate that the LC50 value for TEG aerosol in rats is > 5.2 mg/l.