Registration Dossier
Registration Dossier
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EC number: 413-890-4 | CAS number: 82469-79-2
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- other: 28-day repeated dose
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 413-890-4
- EC Name:
- -
- Cas Number:
- 82469-79-2
- Molecular formula:
- C28H50O8
- IUPAC Name:
- 1,2,3-trihexyl 2-(butanoyloxy)propane-1,2,3-tricarboxylate
Constituent 1
Test animals
- Species:
- other: Rat/Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Details on oral exposure:
- Method of administration:
gavage - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 1000 mg/kg bw/day
Male: 5 animals at 500 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 500 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
No systemic toxicity was observed in body weights or food
consumption.
Laboratory findings:
No real treatment-related trends occurred.
Effects in organs:
Statistically significant increases in relative liver
weights in the males were observed in the 500 and 1000 mg/kg
groups but no increases were seen in the absolute weights
and were thus considered to be biologically significant.
No histopathology occurred which was compound-related.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
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