Registration Dossier
Registration Dossier
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EC number: 444-140-4 | CAS number: -
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 407, "Repeated Dose 28-day Oral Toxicity Study in Rodents".
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 444-140-4
- EC Name:
- -
- Cas Number:
- 18934-00-4
- Molecular formula:
- C12H22O3
- IUPAC Name:
- 3-ethyl-3-{[(3-ethyloxetan-3-yl)methoxy]methyl}oxetane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- other: Rat (Sprague-Dawley)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Details on oral exposure:
- Method of administration: gavage
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 12 animals at 0 mg/kg bw/day
Male: 6 animals at 40 mg/kg bw/day
Male: 6 animals at 200 mg/kg bw/day
Male: 12 animals at 1000 mg/kg bw/day
Female: 12 animals at 0 mg/kg bw/day
Female: 6 animals at 40 mg/kg bw/day
Female: 6 animals at 200 mg/kg bw/day
Female: 12 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
Clinical observation revealed no test substance-related
changes in any group.
No body weight or food consumption examinations showed any
test substance-related changes in any group.
Laboratory findings:
Biochemical examination revealed high values of gamma-GTP
and BUN and low values of glucose and chloride in males in
the 1000 mg/kg group.
Effects in organs:
Organ weight measurement revealed a high value of relative
liver weight in males and females in the 1000 mg/kg group
and a high value of relative kidney weight in males in the
1000 mg/kg group.
Histopathological examination revealed hypertrophy of the
centrilobular hepatocytes in males and females in the 1000
mg/kg group.
High relative liver weights were still apparent in the top
dose group at the end of the recovery period.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- ca. 200 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
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