Registration Dossier
Registration Dossier
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EC number: 204-558-8 | CAS number: 122-62-3
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Carcinogenesis Bioassay of Di(2-ethylhexyl) Adipate
- Author:
- National Toxicology Program
- Year:
- 1 980
- Bibliographic source:
- Technical Report No. 212
Materials and methods
- Principles of method if other than guideline:
- Ten animals per sex per group were fed diets containing the test substance for 13 weeks. Clinical observations were performed twice daily. Body weights and feed consumption were measured weekly. At termination, selected tissues (not specified) were preserved and evaluated histologically.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Bis(2-ethylhexyl) adipate
- EC Number:
- 203-090-1
- EC Name:
- Bis(2-ethylhexyl) adipate
- Cas Number:
- 103-23-1
- Molecular formula:
- C22H42O4
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Details on test material:
- CAS no: 103-23-1
Lot no: LDJ4348
Purity: 99.8%
Supplier: Wako Pure Chemical Industries (Tokyo, Japan)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 600 ppm
- Remarks:
- 0.16%
- Dose / conc.:
- 3 100 ppm
- Remarks:
- 0.31%
- Dose / conc.:
- 6 300 ppm
- Remarks:
- 0.63%
- Dose / conc.:
- 12 500 ppm
- Remarks:
- 1.25%
- Dose / conc.:
- 25 000 ppm
- Remarks:
- 2.5%
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Clinical observations were performed twice daily. Body weights and feed consumption were measured weekly.
- Sacrifice and pathology:
- At termination, selected tissues (not specified) were preserved and evaluated histologically
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One female rat died at 0.16%. This was not considered to be compound-related.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Weight gain in male and female rats was decreased by at least 11% at the 2.5% dose level, and by at least 11% in male rats at the 0.63 and 1.25% dose levels.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- 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:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not specified
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 315 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- 0.63% in feed
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- LOAEL
- Effect level:
- 625 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- 1.25% in feed
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Ten animals per sex per group were fed diets containing the test substance for 13 weeks. Clinical observations were performed twice daily. Body weights and feed consumption were measured weekly. At termination, selected tissues (not specified) were preserved and evaluated histologically.
Results: One female rat died at 0.16% (~80 mg/kg bw/day). This was not considered to be compound-related. Weight gain in male and female rats was decreased by at least 11% at the 2.5% dose level (~1250 mg/kg bw/day), and by at least 11% in male rats at the 0.63 (~315 mg/kg bw/day) and 1.25% (~ 625 mg/kg bw/day) dose levels. Neither compound-related histopathology nor reduction in feed consumption were noted.
NOEL = 0.63 .. % (~315 mg/kg bw/day)
LOEL = 1.25 .. % (~625 mg/kg bw/day)
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