Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

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
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

Constituent 1
Chemical structure
Reference substance name:
2-(2-(2-butoxyethoxy)ethoxy)ethanol
EC Number:
205-592-6
EC Name:
2-(2-(2-butoxyethoxy)ethoxy)ethanol
Cas Number:
143-22-6
Molecular formula:
C10H22O4
IUPAC Name:
2-[2-(2-butoxyethoxy)ethoxy]ethanol
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 or test system 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:
other: 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.