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EC number: 945-883-1 | CAS number: 1379424-11-9
Toxicological information
Repeated dose toxicity: oral
Currently viewing:
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb 1998- Mar 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- Version / remarks:
- Directive 67/548
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 444-000-2
- EC Name:
- -
- Cas Number:
- 647028-25-9
- Molecular formula:
- This is a UVCB so NA
- IUPAC Name:
- 3-[3-(pentanoyloxy)-2,2-bis[(pentanoyloxy)methyl]propoxy]-2,2-bis[(pentanoyloxy)methyl]propyl pentanoate 3-{3-[(3,5,5-trimethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propoxy}-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: straw coloured liquid
- Analytical purity: UVCB tested
- Storage condition of test material: at room temperature in darkness
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Details on oral exposure:
- Substance tested as supplied.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 male animals and 5 female animals per dose
- Control animals:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Laboratory findings:
Haematology/Blood Chemistry: No treatment-related changes in the haematological parameters measured. There were no
treatment-related changes detected in the blood chemical; parameters measured.
Effects in organs:
There were no treatment-related changes detected in the organ weights measured. Males treated with 500 mg/kg/day
showed a statistically significant reduction in absolute epididymides weight when compared with controls but, in the absence of a convincing dose-response relationship, this finding was considered to be incidental and of no toxicological significance.
There were no treatment-related macroscopic abnormalities detected at terminal kill.
Treatment-related kidney changes were observed. Three males treated with 1000 mg/kg/day demonstrated globular accumulations of eosinophilic material in the proximal tubular epithelium which should be regarded as a possible effect of treatment. This finding is consistent with the appearance of hydrocarbon nephropathy and is not considered to represent a hazard to human health.
No such effect was observed among 500 or 150 mg/kg/day animals. - Mortality:
- no mortality observed
- Haematological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment-related changes detected in the organ weights measured. Males treated with 500 mg/kg/day showed a statistically significant reduction in absolute epididymides weight when compared with controls but, in the absence of a convincing dose-response relationship, this finding was considered to be incidental and of no toxicological significance.
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Three males treated with 1000 mg/kg/day demonstrated globular accumulations of eosinophilic material in the proximal tubular epithelium which should be regarded as a possible effect of treatment. This finding is consistent with the appearance of hydrocarbon nephropathy and is not considered to represent a hazard to human health. No such effect was observed among 500 or 150 mg/kg/day animals.
- Details on results:
- There were no treatment-related macroscopic abnormalities detected at terminal kill.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: original NCD unit is mg/kg/day
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: original NCD unit is mg/kg/day
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
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