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Diss Factsheets

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Test procedure:
Citroflex B-6 was administered to 4 male and 4 female beagle
dogs by i.v. administration at doses of 4.62, 46.2 and 462
mg/kg. The dogs were observed for 14 days. Toxicity was
assessed on the basis of overt clinical signs, animal
survival, body weight, body weight gain, ophthalmic
examination, urinalysis, hematology and clinical chemistry
profiles, organ weight and gross and microscopic
pathological changes.
GLP compliance:
yes
Type of method:
in vivo

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

Results and discussion

Details on results:
Increases in SGPT and alkaline phosphatase activities were
seen at 462 mg/kg on the eighth day after administration.
These increases largely reversed themselves by the fifteenth
day after administration.

Applicant's summary and conclusion

Conclusions:
Under the conditions of the test, toxicologically significant effects following the intravenous administration of Citroflex B-6 were restricted to a transient and reversible increase in SGPT and alkaline phosphatase in the 100X dosage group.