Registration Dossier

Toxicological information

Acute Toxicity: inhalation

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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:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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.)