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Diss Factsheets

Administrative data

Description of key information

In the study by Smyth et al., 1951 an oral LD50 of 1870 mg/kg bw was reported for rats after a single application of butyl ethyl ether. Two studies are available to assess the acute inhalation toxicity of butyl ethyl ether. In the study by Marsh & Leake, 1950 the LC50 was determined to be 153000 mg/m³ in mice. In the study Smyth et al., 1951 six rats were exposed for 4 hours to 1000 ppm of butyl ethyl ether. Animals then were observed for 14 days. No mortality occurred. Thus, the LC50 can be considered to be greater than 1000 ppm (equals 4170 mg/m³).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
no data
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 870 mg/kg bw
Based on:
test mat.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In the study by Smyth et al., 1951 an oral LD50 of 1870 mg/kg bw was reported for rats after a single application of the test item.
Executive summary:

In the study by Smyth et al., 1951 an oral LD50 of 1870 mg/kg bw was reported for rats after a single application of butyl ethyl ether. The animals were observed for 14 days.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 870 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
The aim of the study was to determine the anesthetic activity of all the commonly available ethers of from two to ten total carbon numbers.
GLP compliance:
no
Test type:
other: laboratory specific test protocol
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source: the compound was purchased on the open market

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was purified and freshly distilled just prior to use
Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
White mice, weight 18 to 24 g were used for the experiments.
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
Twenty liter, wide-mouth, Pyrex jars were flushed out with oxygen and stoppered. A measured quantity of anesthetic agent was introduced after volatilization had taken place, four mice were placed in the jar. The jar was rotated by hand once every thirty seconds for fifteen minutes. Using this conditions, the mice have approximately 2.5 L of atmosphere available per kilogram of body weight per minute.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
15 min
Concentrations:
not specified
No. of animals per sex per dose:
4
Control animals:
not specified
Details on study design:
Four mice were placed in the jar. The jar was rotated by hand every thirty seconds for fifteen minutes. Any mouse that was unable to right itself for thirty seconds after being rolled on its back was considered anesthetized, and any mouse that developed respiratory collapse and did not recover on exposure to air after the jars was opened was considered dead. No pre-anesthetic medication was used and no attempt was made at reusecitation after removing the mice from the jar. The experiments were repeated until the quantity of ether was found that anesthetize 9 to 11 animals out of a total 20 (AC50), anesthetize 19 of 20 (AC95, 99), kill one (LC1-5), and kill 9 to 11 out of 20 (LC50).
Statistics:
not specified
Sex:
not specified
Dose descriptor:
LC50
Effect level:
153 000 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
15 min
Mortality:
not specified, but to determine the LC50 9 to 11 out of 20 mice died
Clinical signs:
other: not specified
Body weight:
not specified
Gross pathology:
not specified
Interpretation of results:
GHS criteria not met
Conclusions:
In this study, the test item was applied via the inhalation route to four mice for 15 minutes. The LC50 was determined to be 153000 mg/m³.
Executive summary:

In an acute inhalation toxicity study, four white mice were exposed by inhalation route to butyl ethyl ether for 15 min. Any mouse that was unable to right itself for thirty seconds after being rolled on its back was considered anesthetized, and any mouse that developed respiratory collapse and did not recover on exposure to air after the jars was opened was considered dead. The experiments were repeated until the quantity of ether was found that anesthetize 9 to 11 animals out of a total 20 (AC50), anesthetize 19 of 20 (AC95, 99), kill one (LC1-5), and kill 9 to 11 out of 20 (LC50). As reported in the publication, the LC50 was determined to be 153000 mg/m³.

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study was conducted before OECD testing guidelines were established. 6 animals were treated via inhalation to a vapour of butyl ethyl ether for a total of 4 hours. Afterwards, the animals were observed for 14 days for mortality.
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
not specified
Duration of exposure:
4 h
Concentrations:
1000 ppm (= 4170 mg/m³)
No. of animals per sex per dose:
6 animals in total used, sex not specified
Statistics:
no data
Sex:
not specified
Dose descriptor:
LC0
Effect level:
1 000 ppm
Based on:
test mat.
Exp. duration:
4 h
Key result
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 1 000 ppm
Based on:
test mat.
Exp. duration:
4 h
Mortality:
no mortality occurred
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute inhalation toxicity study 6 rats were exposed for 4 hours to 1000 ppm of butyl ethyl ether. Animals then were observed for 14 days. No mortality occured. Thus, the LC50 can be considered to be greater than 1000 ppm (equals 4170 mg/m³)
Executive summary:

In an acute inhalation toxicity study 6 rats were exposed for 4 hours to 1000 ppm of butyl ethyl ether. Animals then were observed for 14 days. No mortality occured. Thus, the LC50 can be considered to be greater than 1000 ppm (equals 4170 mg/m³)

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the study by Smyth et al., 1951 an oral LD50 of 1870 mg/kg bw was reported for rats after a single application of butyl ethyl ether. Two studies are available to assess the acute inhalation toxicity of butyl ethyl ether. In the study by Marsh & Leake, 1950 the LC50 was determined to be 153000 mg/m³ in mice. In the study Smyth et al., 1951 six rats were exposed for 4 hours to 1000 ppm of butyl ethyl ether. Animals then were observed for 14 days. No mortality occurred. Thus, the LC50 can be considered to be greater than 1000 ppm (1000 ppm equals 4170 mg/m³).

Justification for classification or non-classification

Based on the results from an acute oral toxicity study, butyl ethyl ether does warrant classification for acute oral toxicity [Cat. 4, H302]. By assessing the available data for acute inhalation toxicity in rats and mice in a weight-of-evidence approach, no classification is warranted for acute inhalation toxicity.