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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum. Therefore the reliability statement below can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
413-110-2
EC Name:
-
Cas Number:
135861-56-2
Molecular formula:
C24H30O6
IUPAC Name:
(1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
olive oil
Details on oral exposure:
Method of administration: gavage
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 daysfweek
No. of animals per sex per dose:
Male: 6 animals at 0 mg/kg bW/day
Male: 6 animals at 8 mg/kg bw/day
Male: 6 animals at 40 mg/kg bw/day
Male: 6 animals at 200 mg/kg bw/day
Male: 6 animals at 1000 mg/kg bw/day
Female: 6 animals at 0 mg/kg bw/day
Female: 6 animals at 8 mg/kg bw/day
Female: 6 animals at 40 mg/kg bw/day
Female: 6 animals at 200 mg/kg bw/day
Female: 6 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
There were no deaths during the study period.
Mortality:
no mortality observed
Description (incidence):
There were no deaths during the study period.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No abnormalities were noted in the dosing period.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No abnormalities were noted in the dosing period.
Haematological findings:
no effects observed
Description (incidence and severity):
No abnormalities were noted at the end of the study period.
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
No abnormalities were noted at the end of the study period.
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
Increased absolute and relative liver weights were noted In males of the 1000 mg/kg/day dose group. No other related changes were noted.
Gross pathological findings:
no effects observed
Description (incidence and severity):
No abnormalities were noted at necropsy at the end of the study period.
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
No treatment-related effects were observed.
Details on results:
Clinical observations:
Mortality Data:
There were no deaths during the study period.
Clinical Observations:
No treatment-related observations.
Bodyweight:
No abnormalities were noted in the dosing period.
Food Consumption:
No abnormalities were noted during the dosing period.
Laboratory findings:
Haematology:
No abnormalities were noted at the end of the study period.
Blood Chemistry:
No abnormalities were noted at the end of the study period.
Effects in organs:
Necropsy:
No abnormalities were noted at necropsy at the end of the
study period.
Organ Weights:
Increased absolute and relative liver weights were noted In
males of the 1000 mg/kg/day dose group. No other related
changes were noted.
Histopathology:
No treatment-related effects were observed.
Cyst formation in the kidney was noted in both sexes of the
1000 mg/kgfday dose groups. This was not considered
due to the test substance as this observation is common in
this strain of rat and was also noted in control group
animals.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCO unit Is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
200 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCO unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified
Executive summary:

Not classified