Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Testing described in reputable secondary literature source.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Method not elaborated in secondary literature source.
GLP compliance:
not specified

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:
rat

Administration / exposure

Route of administration:
intravenous
Duration of treatment / exposure:
IV administration of BTHC (0, 5, 50, 500 mg/kg kg bw/day) on days 6-15 of gestation.
Frequency of treatment:
IV administration of BTHC (0, 5, 50, 500 mg/kg kg bw/day) on days 6-15 of gestation.
Duration of test:
IV administration of BTHC (0, 5, 50, 500 mg/kg kg bw/day) on days 6-15 of gestation.

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Remarks on result:
other: No deaths or dose dependent changes in kg bw/ or uterine weight were identified. However in line with the findings from repeat dose studies, changes were observed in liver, lung and spleen weight in the mothers.

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Dose descriptor:
NOEL
Effect level:
500 mg/kg bw/day
Basis for effect level:
other: fetotoxicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
An NOEL for foetal/embryo toxicity of 500 mg/kg kg bw/day can be estimated in this study.