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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:
1991

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

Constituent 1
Chemical structure
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

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