Registration Dossier
Registration Dossier
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EC number: 205-450-3 | CAS number: 141-04-8
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Dibutyl adipate
- EC Number:
- 203-350-4
- EC Name:
- Dibutyl adipate
- Cas Number:
- 105-99-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- dibutyl adipate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- yes
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 20 mg/kg bw/day (nominal)
- Dose / conc.:
- 140 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Control animals:
- 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:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effect observed at highest dose
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- System:
- haematopoietic
- Organ:
- kidney
- liver
Any other information on results incl. tables
Species/strain: Rat (Crj:CD(SD))
Sex: Female [ ]; Male [ ]; Male/Female [X]; No data [ ]
Route of Administration: oral gavage
Exposure period: 28 days
Frequency of treatment: 7 days/week
Post exposure observation period: 14 days
Dose: 0, 20, 140 or 1000 mg/kg (6 animals /group)
Control group: Yes [X]; No [ ]; No data [ ]; olive oil
Concurrent no treatment [ ]; Concurrent vehicle [X]; Historical [ ]
NOEL: 1,000 mg/kg/day
Results: No test substance-related changes were noted in clinical observations,
body weight gains, food consumption, and the findings obtained from
hematology testing, blood chemical examination, urinalysis, and
pathological examination.
Method: Guidelines for 28-Day Repeat Dose Toxicity Test of Chemicals
(Japan)
GLP: Yes [X] No [ ] ? [ ]
Test substance: Commercial, purity: 99.8 %
Reference: MHW, Japan (1996b)
Applicant's summary and conclusion
- Conclusions:
- No test substance-related changes were noted in clinical observations, body weight gains, food consumption, and the findings obtained from hematology testing, blood chemical examination, urinalysis, and pathological examination. The NOAELs were considered to be 1,000 mg/kg/day in both sexes.
- Executive summary:
oral toxicity in rats according to the 28-day repeated dose toxicity test [Japanese TG ].
As the study was well controlled and conducted under GLP, it is regarded as a key study. Male and
female SD rats were orally administered (gavage) at doses of 0, 20, 140 and 1,000 mg/kg/day.
No test substance-related changes were noted in clinical observations, body weight gains, food
consumption, and the findings obtained from hematology testing, blood chemical examination,
urinalysis, and pathological examination. The NOAELs were considered to be 1,000 mg/kg/day in
both sexes (MHW, 1996b).
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