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Toxicological information

Repeated dose toxicity: oral

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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:
2008
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:
1990
Bibliographic source:
Chicago, IL., November 8, 1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
Version / remarks:
No detailed but NJDEP validation
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
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 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.