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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:
2003
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

Constituent 1
Chemical structure
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

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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