Registration Dossier
Registration Dossier
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EC number: 406-176-9 | CAS number: 79072-96-1 NC-4
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol
- EC Number:
- 406-176-9
- EC Name:
- 2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol
- Cas Number:
- 79072-96-1
- Molecular formula:
- C24 H30 O6
- IUPAC Name:
- 1-[2,6-bis(4-ethylphenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- Method of administration: Diet
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Treated diet available throughout study
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- Control
- Dose / conc.:
- 5 000 ppm
- Dose / conc.:
- 15 000 ppm
- Dose / conc.:
- 50 000 ppm
- No. of animals per sex per dose:
- 20 males and 20 females per dose
- Control animals:
- yes, plain diet
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
FOOD EFFICIENCY: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes
URINALYSIS: Yes
NEUROBEHAVIOURAL EXAMINATION: Not specified - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Details on results:
- CLINICAL OBSERVATIONS:
No deaths occurred nor abnormal symtoms in any of treated or control groups throughout the study.
There were also no abnormal symtoms in the general conditions of the satellite group.
Appearance, behaviour, mortality, body weight gain, food consumption, water intake and food efficiency of rats treated were not affected throughout the study.
LABORATORY FINDINGS:
In the interim examination of the satellite group in weeks 5, 9 and 13, there were no abnormalities in urinanalysis, hematology and clinical chemistry parameters attrtibuted to the test material.
In the terminal examination at the end of the treatment period of 13 weeks, there were no abnormalities in urinanalysis, hematology, clinical chemistry, necropsy, organ weight and histopathology parameters attributed to the test material.
EFFCTS IN ORGANS:
There were no significant changes between the treated and control groups or absolute and relative organ weight.
In absolute organ weight, pituitary weight of females fed 15000 ppm, thymic gland, heart, lung, liver and kidney of females fed 50000 ppm increased significantly when compared with those of the control group. In relative organ weight, thymic gland and kidney decreased in females fed 5000 ppm and relative brain weight decreased in females fed 50000 ppm.
Histopathological changes were seen in the pituitary, thyroids, thymus, liver, kidney, stomach, duodenum, urinary bladder, testis, prostate and skeletal muscle of treated or control animals. These abnormalities were spontaneous or accidental changes, normal for species and ages of the test animals.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 50 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Dose at which no toxic effects were observed
- Dose descriptor:
- NOAEL
- Remarks:
- Equivalent dose based on food intake/bodyweight
- Effect level:
- 3 020 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Dose at which no toxic effects were observed
- Dose descriptor:
- NOAEL
- Remarks:
- Equivalent dose based on food intake/bodyweight
- Effect level:
- 3 240 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Dose at which no toxic effects were observed
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Dose/concentration at which no toxic effects were observed: 50000 ppm; 3.02 g/kg/day (males); 3.24 g/kg/day (females)
Applicant's summary and conclusion
- Conclusions:
- In a 13-week repeated dose toxicity oral feed study, rats were treated at concentrations up to 50000 ppm. No significant adverse toxic effects were observed at 50000 ppm in the parameters examined.
The NOAEL is considered to be 50000 ppm; equivalent to 3020 mg/kg bw/day in males and 3240 mg/kg bw/day in females.
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