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Toxicological information

Acute Toxicity: inhalation

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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. certificate)
Remarks:
testing lab.
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.7%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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.