Registration Dossier
Registration Dossier
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EC number: 203-933-3 | CAS number: 112-07-2
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
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:
- 1 979
- 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)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- 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:
- Source: Pfaltz & Bauer, Flushing, NY.
Name: ethylene glycol monobutylether acetate
Purity: no details
Constituent 1
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:
- LC50
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- No llethality seen at the maximum acheivable vapour concentration.
- Mortality:
- All animals survived
- 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 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.
Synopsis
LD0 (male and female rats) >400ppm (2.66mg/l, the maximum concentration attainable.)
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