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Unpublished report prepared for Fleischmann Laboratories, Consultants, Philadelphia; cited in FASEB, 1977 & JEFCA, 1979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 triethyl citrate 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 tributyl citrate (CAS 77-94-1) as it is a near analogue to the test substance triethyl citrate.