Registration Dossier
Registration Dossier
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EC number: 413-110-2 | CAS number: 135861-56-2
Repeated dose toxicity: oral
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: Annex V guideline study with GLP compliance
Data source
Reference
- Reference Type:
- other: inquiry result from ECHA
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Limit test:
- no
Test material
- 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
Constituent 1
Test animals
- Species:
- other: Rat (Crj: CD(SD))
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- olive oil
- Details on oral exposure:
- Method 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: 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
- Details on results:
- CLINICAL OBSERVATIONS:
MORTALITY DATA:
There were no deaths during the study.
CLINICAL OBSERVATIONS:
No treatment-related observations.
BODY WEIGHT:
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
EFECTS 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 at 1000 mg/kg bw/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/kg bw/day dose groups. This was not considered to be 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 NCD unit is mg/kg/day
- Dose descriptor:
- NOEL
- Effect level:
- 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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