Registration Dossier
Registration Dossier
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EC number: 201-071-2 | CAS number: 77-94-1
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
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Toxicity Profile Triethyl citrate
- Author:
- TNO BIBRA International Ltd.
- Year:
- 1 998
- Bibliographic source:
- Toxicity Profile Triethyl citrate, TNO BIBRA, 1998
- Reference Type:
- other: primary source
- Title:
- Triethyl citrate lifetime study on rats.
- Author:
- LaWall & Harrison
- Year:
- 1 954
- Bibliographic source:
- Unpublished report prepared for Fleischmann Laboratories, Standard Brands, Inc., Stamford, Conn., USA; cited in FASEB, 1977 & JEFCA, 1979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
- Reference substance name:
- Triethyl citrate
- EC Number:
- 201-070-7
- EC Name:
- Triethyl citrate
- Cas Number:
- 77-93-0
- Molecular formula:
- C12H20O7
- IUPAC Name:
- triethyl citrate
Constituent 1
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.
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