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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:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Purity of the test material was not listed. Concentration of material in the atmosphere was not analyzed.

Data source

Reference
Reference Type:
publication
Title:
The comparative acute toxicity|and primary irritancy of the monohexyl ethers of ethylene|and diethylene glycol.
Author:
Ballantyne B,; Myers R. C.
Year:
1987
Bibliographic source:
Vet Human Tox 29:361-366

Materials and methods

Principles of method if other than guideline:
Five rats of each sex weighing between 200 and 300g were exposed to a statically generated saturated vapour for 6 hours.
GLP compliance:
no
Test type:
fixed concentration procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): diethylene glycol monohexyl ether (DGHE)
- Physical state: Colorless liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
The animals were maintained on appropriate commercial diet and municipal water. Both were available adlibitum except during exposure period.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
not specified
Details on inhalation exposure:
Five rats of each sex weighing between 200 and 300g were exposed to a statically generated saturated vapour for 6 hours. The vapour was produced by enclosing the test material into a sealed 120 liter animal chamber and allowing the vapour to equilibrate for 18 hours (Static condition). Rats were introduced into separate chambers through gasketted drawers designed to minimize vapour loss. Oxygen content was continuously monitored and maintained at 20%. Animals were removed from the chamber after 6 hours of exposure and were observed for 14 days. Body weights were measured before exposure and 7 and 14 days following exposure. All rats were subjected to necropsy after the 14 day observation period.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
6 h
Concentrations:
Substantially Saturated vapour (Static)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The animals were maintained on appropriate commercial diet and municipal water. Both were available adlibitum except during exposure period.
Five rats of each sex weighing between 200 and 300g were exposed to a statically generated saturated vapour for 6 hours. The vapour was produced by enclosing the test material into a sealed 120 liter animal chamber and allowing the vapour to equilibrate for 18 hours (Static condition). Rats were introduced into separate chambers through gasketted drawers designed to minimize vapour loss. Oxygen content was continuously monitored and maintained at 20%. Animals were removed from the chamber after 6 hours of exposure and were observed for 14 days. Body weights were measured before exposure and 7 and 14 days following exposure. All rats were subjected to necropsy after the 14 day observation period.
Statistics:
Not applied

Results and discussion

Preliminary study:
No data available
Effect levels
Key result
Sex:
male/female
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: Substantial Saturated Vapours-Concentration Unknown
Remarks:
No mortality occurred
Mortality:
None. All animals survived the 6 hour exposure.
Clinical signs:
There were no signs of toxicity or irritancy during or after exposure.
Body weight:
Body weight gain was observed across the treatment groups.
Gross pathology:
None
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
No signs of inhalation toxicity were observed when rats were exposed to substantially saturated vapours for 6 hours.
Executive summary:

Five rats of each sex weighing between 200 and 300g were exposed to a statically generated saturated vapour for 6 hours. The vapour was produced by enclosing the test material into a sealed 120 liter animal chamber and allowing the vapour to equilibrate for 18 hours (Static condition). Rats were introduced into separate chambers through gasketted drawers designed to minimize vapour loss. Oxygen content was continuously monitored and maintained at 20%. Animals were removed from the chamber after 6 hours of exposure and were observed for 14 days. Body weights were measured before exposure and 7 and 14 days following exposure. All rats were subjected to necropsy after the 14 day observation period. All animals survived the 6 hour exposure. There were no signs of toxicity or irritancy during or after exposure. Animals gained weight over the fourteen day observation period and had normal pathology.