Tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate

Carcinogenicity

Administrative data

Endpoint:

carcinogenicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: secondary literature

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

Toxicity Profile Triethyl citrate

Author:

TNO BIBRA International Ltd.

Year:

1998

Bibliographic source:

Toxicity Profile Triethyl citrate, TNO BIBRA, 1998

Reference 2

Reference Type:

other: primary source

Title:

No information

Author:

LaWall & Harrison

Year:

1954

Bibliographic source:

Unpublished report prepared for Fleischmann Laboratories, Consultants, Philadelphia; cited in FASEB, 1977 & JEFCA, 1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: no data

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Triethyl citrate

EC Number:

201-070-7

EC Name:

Triethyl citrate

Cas Number:

77-93-0

IUPAC Name:

triethyl citrate

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

oral: feed

Vehicle:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

2 years

Doses / concentrations

Remarks:

Doses / Concentrations:
1.5 g/kg bw/day (3%)
Basis:
nominal in diet

No. of animals per sex per dose:

15 male and 15 female

Results and discussion

Results of examinations

Details on results:

There was no evidence of carcinogenic activity in the limited study.

Relevance of carcinogenic effects / potential:

The results of the study did not indicate a carcinogenic potential for triethyl citrate in rats.

Applicant's summary and conclusion

Conclusions:

There was no evidence of a carcinogenic potential of triethyl citrate in rats.

Executive summary:

In a limited study in which rats were given triethylcitrate in the diet at up to 3% (about 1.5 g/kg bw/day) for 2 years no evidence of carcinogenic activity was noted (La Wall and Harrison, 1954, cited in TNO BIBRA, 1998). It can be assumed that the same applies to tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate (CAS 144 -15 -0) as it is a near analogue to the test substance triethyl citrate.