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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1962
Reference Type:
publication
Title:
Glycol Ethers and Other|SelectedGlycol Derivates"; in Clayton G.D and Clayton F.E.|(eds.): Patty's Industrial Hygiene and Toxicology, 4th ed.
Author:
Smyth H.F. et al.
Year:
1994
Bibliographic source:
Am. Ind. Hyg. Assoc. J., 23, 95, (1962);|cited in Gingel R. et al.:Clayton F.E.|(eds.): Patty's Industrial Hygiene and Toxicology, 4th ed.,|Vol.2, Part D, pp. 2761-2964, (1994)
Reference Type:
review article or handbook
Title:
Doc.Nr. 878216157, NTIS/OTS 0206832
Author:
EPA
Year:
1994
Bibliographic source:
TSCATS EPA/OTS Doc.Nr. 878216157, NTIS/OTS 0206832
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Inhalation hazard test according to the method described by Smyth H.F. et al.: Am. Ind. Hyg. Ass. J. 23, 95-107, (1962).
Principles of method if other than guideline:
Inhalation hazard test according to the method described by Smyth H.F. et al.: Am. Ind. Hyg. Ass. J. 23, 95-107, (1962). See details below.
GLP compliance:
no
Test type:
other: Inhalation Hazard Test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report):
- Analytical purity: 99% (pure)
Triethylene glycol monobutyl ether

Test animals

Species:
rat
Strain:
other: Carworth Wistar albino rats
Sex:
male/female
Details on test animals and environmental conditions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12h / 12h

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Male or female rats were exposed to a flowing stream of vapor-ladened air generated by passing 2.5 l/min of dried air at room
temperature through a fritted disc immersed to a depth of at least once inch in approximately 50 ml of test material contained in a
gas-washing bottle.
Rats were exposed from time periods ranging from 15 minutes to 8 hours (until the inhalation period killing about one half of the rats
within 14 days was defined).
Analytical verification of test atmosphere concentrations:
no
Remarks:
No analytical determination of the atmosphere concentrations was performed.
Duration of exposure:
8 h
Concentrations:
4 hr: 600mg/l
8 hr: 1200mg/l
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, histopathology

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LCLo
Effect level:
1 200 mg/m³ air
Based on:
test mat.
Exp. duration:
8 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2 400 mg/m³ air
Based on:
test mat.
Exp. duration:
16 h
Remarks on result:
other: estimated LC50 from available data
Sex:
male/female
Dose descriptor:
other: NOAEC
Effect level:
480 mg/m³ air
Based on:
test mat.
Exp. duration:
16 h
Remarks on result:
other: estimated NOAEC from available data
Mortality:
Rats were exposed from time periods ranging from 15 minutes to 8 hours (until the inhalation period killing about one half of the rats within 14 days was defined).
No mortality was observed after 8 h exposure.
Clinical signs:
no significant adverse effects.
Body weight:
Body weights were not determined neither during the exposure nor at the end of the test.
Gross pathology:
The animals that were sacrificed and submitted to necropsy at the end of the observation period were without findings.

Any other information on results incl. tables

Exposure

Mortality

Dead/Treated

8h

0/6

16h

3/6

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute inhalation toxicity designed to assess vapour concentrations that did not cause death, groups of 6 animals were exposed sequentially to increasing concentrations of 2-(2-(2-butoxyethoxy)ethoxy)ethanol.
8 hours exposure to 1200mg/l caused no deaths whereas 16 hours at 2400mg/l caused 3/6 animals to die. Based on this study, the LC50 would be >2400 mg/l.
It can be concluded that the test substance does not present an acute inhalation hazard.

Executive summary:

In an acute inhalation toxicity designed to assess vapour concentrations that did not cause death, groups of 6 animals were exposed sequentially to increasing concentrations of 2-(2-(2-butoxyethoxy)ethoxy)ethanol.

8 hours exposure to 1200mg/l caused no deaths whereas 16 hours at 2400mg/l caused 3/6 animals to die. Based on this study, the LC50 would be >2400 mg/l.

It can be concluded that the test substance does not present an acute inhalation hazard.