Registration Dossier
Registration Dossier
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EC number: 212-611-1 | CAS number: 831-82-3
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Ground Water Quality Standard for Diphenyl Ether (CASRN 101-84-8).
- Author:
- New Jersey Department of Environmental Protection
- Year:
- 2 008
- Bibliographic source:
- Available from the New Jersey Department of Environmental Protection at: www.nj.gov/dep/wms/bwqsa/diphenyl_ether.pdf
- Reference Type:
- publication
- Title:
- Thirteen-week oral (diet) toxicity study of diphenyl ether in rats. Final Report.
- Author:
- IITRI
- Year:
- 1 990
- Bibliographic source:
- Chicago, IL., November 8, 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- No detailed but NJDEP validation
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Diphenyl ether
- EC Number:
- 202-981-2
- EC Name:
- Diphenyl ether
- Cas Number:
- 101-84-8
- Molecular formula:
- C12H10O
- IUPAC Name:
- Diphenyl Ether
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- Not specified
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- Not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not specified
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- Not specified
- Vehicle:
- not specified
- Details on oral exposure:
- Not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- By feed (daily)
Doses / concentrations
- Dose / conc.:
- 15 mg/kg bw/day (nominal)
- Remarks:
- it is the higher dose in females
- No. of animals per sex per dose:
- Not specified
- Control animals:
- not specified
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Not specified
DETAILED CLINICAL OBSERVATIONS: Not specified
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE : Not specified
FOOD EFFICIENCY: Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Not specified
CLINICAL CHEMISTRY: Not specified
URINALYSIS: Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified
IMMUNOLOGY: Not specified
- Sacrifice and pathology:
- Not specified
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Effects on body weight occurred at higher doses in females
- 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):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 15 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In the rat dietary subchronic study, the No Observed Adverse Effect Level (NOAEL) was 15 mg/kg/day.
- Executive summary:
In the rat dietary subchronic study, the No Observed Adverse Effect Level (NOAEL) was 15 mg/kg/day.
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