2-(2-butoxyethoxy)ethyl acetate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study which meets basic scientific principles and contains sufficient detail to be able to judge the results reliable as a contribution to the understanding of the toxicity of this substance.

Data source

Reference

Reference Type:

publication

Title:

Comparative toxicological study of ethyl glycol acetate and butyl glycol acetate

Author:

Truhaut R, Dutertre-Catella H, Phu-Lich N, Ngoc Huyen V

Year:

1979

Bibliographic source:

Toxicol Appl Pharmac 51, 117-27

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-butoxyethyl acetate

EC Number:

203-933-3

EC Name:

2-butoxyethyl acetate

Cas Number:

112-07-2

Molecular formula:

C8H16O3

IUPAC Name:

2-butoxyethyl acetate

Details on test material:

DETAILS OF SURROGATE SUBSTANCE

PHYSICO-CHEMICAL PROPERTIES
- Melting point: 209K
- Boiling point: 465K
- Vapour pressure: 50Pa
- Water solubility (under test conditions): 15,000mg/l
- Henry's law constant: 0.53Pa.m3/mol
- log Pow: 1.51
- pKa: no dissociatable groups
- Stability in water: Yes at neutral pH
- Stability in light: Yes
- pH dependance on stability: Yes

OTHER PROPERTIES (if relevant for this endpoint)
- Other: The surrogate material shares the same key structural features of a glycol ether with a free hydroxyl group at one end of the molecule that has been esterified with an acetic acid group and a normal butyl hydrocarbon chain at the other. The difference with this substance is that there is an extra CH2CH2O ethoxy group separating the two functional groups. The surrogate substance is likely to show a higher acute toxicity than the substance for which this dossier is prepared, therefore the test (surrogate) substance can be considered a conservative option for read across.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Evic-Ceba, Blanquefort, France
- Fasting period before study: 16-24hrs overnight
- Weights at start of study: 220-240g
- Food and water: ad libitum
- Housing: wire bottom cages, 10 per cage during acclimation.
- Acclimation period: 2 weeks

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Classical gas chamber as described in Truhaut (Arch Mal Prof Med Trav Secur Soc, 28, 425-34, 1967 - In French)
- Saturated Vapour generation: Solvent bubbler with sintered glass bottom. Air passed through bottom and hence through liquid then saturated air transported to exposure chamber.
- Source and rate of air: 1000 l/hr

Analytical verification of test atmosphere concentrations:

not specified

Remarks:

no details provided.

Duration of exposure:

4 h

Concentrations:

0, saturated vapour concentration (quantified as approximately 400ppm)

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations and weighing: Weights were recorded before dosing and at the end of the 14-day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: The presence of blood, protein, glucose, ketone bodies and nitrites in the urine and urine pH was measured with test strips (times not indicated). Red and white blood cells in urine were counted with a Coulter counter. Hemoglobin was also measured. All animals were necropsied upon death. Heart, lungs, liver, spleen, pancreas, kidneys, adrenals, ovaries, bladder, skin, brain and testes were fixed and examined histologically.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC0

Effect level:

> 400 ppm

Exp. duration:

4 h

Remarks on result:

other: This was the maximum acheivable vapour concentration.

Mortality:

All animals survived

Clinical signs:

other: No adverse effects reported.

Body weight:

No adverse effects reported.

Gross pathology:

no data

Other findings:

No adverse effects reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LC50 concentration cannot be achieved under ambient conditions due to the low volatility of the substance.

Executive summary:

In an acute inhalation toxicity study in rats where basic study details were reported, the LC50 of 2 -butoxyethyl acetate (a read across substance for 2 -(2 -butoxyethoxy)ethyl acetate - 22BEEA) could not be established due to the low volatility of the substance. Exposure to the saturated vapour concentration (quantified as approximately 400ppm) for 4 hours produced no adverse response. Based on this result, this substance does not need to be classified as harmful for acute inhalation toxicity. By inference and the fact that the substance that is the subject of this registration dossier is significantly less volatile still, this result can also be extended as part of a weight of evidence approach to assess the likely inhalation toxicity of 22BEEA.

Synopsis

LD0 (male and female rats) >400ppm (2.66mg/l, the maximum concentration attainable.)