Registration Dossier
Registration Dossier
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EC number: 203-678-8 | CAS number: 109-53-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Restrictions: purity of test substance not reported; observation period only 7 days; no data about body weight.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (post exposure observation period 7 days)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Isobutyl vinyl ether
- EC Number:
- 203-678-8
- EC Name:
- Isobutyl vinyl ether
- Cas Number:
- 109-53-5
- Molecular formula:
- C6H12O
- IUPAC Name:
- 1-(ethenyloxy)-2-methylpropane
- Details on test material:
- Isobutylvinylether (IBVE)
no further data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Gassner
Mean body weights: 199 g (males), 169 g (females)
no further details
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- aqueous carboxymethyl cellulose (CMC) emulsion, content of IBVE 30%.
- Doses:
- Dose levels: 6400, 8000, and 10000 µL/kg bw (i.e. 4920, 6150, 7690 mg/kg bw).
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Weighing: initial weight
- Necropsy of survivors performed: yes - Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 700 mg/kg bw
- Remarks on result:
- other: (10 mL/kg bw); no mortality at this dose level
- Mortality:
- There was no mortality except 1/5 mid dose female that died within 48 h postdose.
- Clinical signs:
- other: Low dose animals: stagger within few minutes. Hunched posture, apathy, and dyspnoea within hours. Eyes reddish encrusted for several days. No findings on day 5 postdose and thereafter. Mid and high dose animals: abdominal position, apathy, dyspnoea. Hun
- Gross pathology:
- General congestion.
- Other findings:
- no data
Applicant's summary and conclusion
- Conclusions:
- In an acute oral toxicity study in rats the LD50 was >10 mL/kg bw (corresponding to >7700 mg/kg bw) at a post exposure observation period of 7 days.
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