Registration Dossier

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

Referenceopen allclose all

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 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Unpublished report prepared for Fleischmann Laboratories, Consultants, Philadelphia; cited in FASEB, 1977 & JEFCA, 1979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:
other: no data
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

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.