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Diss Factsheets

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl vinyl ether
EC Number:
203-718-4
EC Name:
Ethyl vinyl ether
Cas Number:
109-92-2
Molecular formula:
C4H8O
IUPAC Name:
ethoxyethene
Details on test material:
ethyl vinyl ether (EVE)
purity > 99.5%
stability during experiment was given
no further data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K . Thomae GmbH, Biberach
- Age at study initiation: 8-9 weeks
- Weight at study initiation: males 257+-10 g and females 185+-10 g
- Fasting period before study: no data
- Housing: singly
- Diet ad libitum, certified diet (analysed for contaminations)
- Tap water ad libitum (analysed for contaminations)
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
The animals were singly placed into compartments of an inhalation chamber (glass-steel, volume 200 L). Atmosphere was dynamically generated. Air passed an evaporator to which TS was pumped. Vapours were mixed with fresh air. Air was delivered to the inhalation chamber at a rate of 3000 L/h.

Analytical verification of test atmosphere concentrations:
yes
Remarks:
[concentration measured by gas chromatography (calibration; 4 samples measured)]
Duration of exposure:
4 h
Concentrations:
21.2 mg/L (mean of 4 samples; comment: in OECD Guideline 5 mg/L recommended for the limit test)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: clinical observations during exposure at least once daily thereafter
- Necropsy of survivors performed: yes
- body weight: once weekly (day 0, 7, 14)
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
21.2 mg/L air
Exp. duration:
4 h
Remarks on result:
other: (7200 ppm) no lethal effects in males and females
Mortality:
no mortality
Clinical signs:
other: During exposure: marked apathia, closed lids, depressed breathing, unkempt fur. After exposure: unkempt fur. No symptoms were noted from the day following exposure.
Body weight:
Body weight development of male and female rats was comparable to historical control data over the entire observation period.
Gross pathology:
no effects detected
Other findings:
no

Applicant's summary and conclusion

Conclusions:
In the Limit test in 5 male and 5 female Wistar rats (according to OECD Guideline 403) no mortality was found but clinical signs (sedation) at a concentration of 21 mg/L (7200 ppm) and an exposure duration of 4 h. Apathy, closed lids and depressed breathing were noted during exposure, these clinical signs were absent the following day. No effects were detcted at necropsy 2 weeks after exposure.