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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:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
isobutyl vinyl ether (IBVE)
purity > 99.5%
Stability was given during study period

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Mean body weights: 267 and 183 g for male and female rats, respectively
Age: 8 to 9 weeks at start of treatment
Rats received standard diets and water ad libitum
Room temperature was 20-24°C
Relative air humidity 30-70%.

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 in an inhalation chamber (glass-steel, volume 200 l). Atmosphere was dynamically generated. Air passed an evaporator to which TS was pumped. Vapors 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:
(the concentration was measured using gas chromatography)
Duration of exposure:
4 h
Concentrations:
21.1 mg/L
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Post exposure period was 14 days.
The animals were observed for clinical signs of toxicity on working days and daily for mortality for 14 days. Body weights were recorded on days 0, 7, and 14. At the end of the observation period the animals were sacrificed and necropsied.
Statistics:
Binominal test (Wittig 1974) was used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
21.1 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: clinical signs but no mortality, 14 d observation period
Mortality:
no mortality
Clinical signs:
other: During exposure: apathia, stagger, depressed breathing, reddened ears and extremities, unkempt fur. After exposure: unsteady gait. No symptoms were noted from the day following exposure.
Body weight:
Body weight development was comparable to historical controls but slightly delayed in females.
Gross pathology:
No effects detected at necropsy.
Other findings:
no

Applicant's summary and conclusion

Conclusions:
In an acute inhalation study in rats no mortality was found after 4 h exposure to 21.1 mg/L and a post exposure period of 14 days (the recommended limit dose according to OECD TG403 is 5 mg/L); LC50 (4h) > 21 mg/L.