Glycerol trioctanoate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Acceptable, well documented publication which meets basic scientific principles.

Data source

Reference

Reference Type:

publication

Title:

Tests for dominant-lethal effects of 1,2-dibromo-3-chloropropane (DBCP) in male and female mice

Author:

Generoso, W.M. et al.

Year:

1985

Bibliographic source:

Mutation research 156: 103-108

Materials and methods

Principles of method if other than guideline:

Tricaprylin was used as solvent control in a female dominant-lethal study with 1,2-dibromo-3-chloropropane (DBCP).

GLP compliance:

not specified

Type of assay:

rodent dominant lethal assay

Test material

Test material information

Constituent 1

Reference substance name:

Glycerol trioctanoate

EC Number:

208-686-5

EC Name:

Glycerol trioctanoate

Cas Number:

538-23-8

Molecular formula:

C27H50O6

IUPAC Name:

1,3-bis(octanoyloxy)propan-2-yl octanoate

Details on test material:

- Name of test material (as cited in study report): Tricaprylin

Test animals

Species:

mouse

Strain:

other: T-stock and (C3HxC57BL)F1

Sex:

female

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

- Vehicle(s)/solvent(s) used: None
- Justification for choice of solvent/vehicle: Tricaprylin served as solvent control in the study.

Details on exposure:

One experiment in T-stock females and a second experiment in T-stock and (C3HxC57BL) F1 females were conducted. Over a period of six days post dosing, the females were mated with (C3HxC57BL) F1 males.

Frequency of treatment:

single injection

Doses / concentrations

Dose / conc.:

7.6 mg/kg bw (total dose)

Remarks:

0.2 mL/animal; mean dose value as calculated from a body weight of 25 g and density of 0.954 g/L

No. of animals per sex per dose:

First experiment
T-stock: 44 females

Second experiment
T-stock: 47 females
(C3HxC57BL)F1: 37 females

Control animals:

no

Positive control(s):

none

Results and discussion

Test results

Key result

Sex:

female

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

other: Tricaprylin served as solvent control in the study.

Negative controls validity:

not examined

Positive controls validity:

not examined

Any other information on results incl. tables

Table 1: Dominant-lethal studies in female mice

Experiment	Stock of females	Number of mated females	Number of pregnant females	Number of implantations per pregnant females	Number of living embryos per pregnant females	Dead implants (%)
I	T-stock	44	41	8.4	7.3	13.4
II	(C3HxC57BL)F1	37	29	9.4	8.9	5.5
	T-stock	47	42	8.2	6.9	15.9

For both, tricaprylin and DBCP, dominant-lethal parameters were in the same range, revealing no induction of dominant lethal mutations in female germ cells.

Applicant's summary and conclusion

Conclusions:

No adverse effects on number of pregnant females, number of implantations/females, number of living embryos/pregnant female, dead implants (%) were found after single intraperitoneal injection of Glycerol trioctanoate (CAS 538-23-8) at a dose of 7.6 mg/kg bw to female mice in a dominant lethal study. The administered dose is not sufficient for assessment.