Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: reliable scientific study, precedes guidelines and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1954
Report Date:
1954

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Lifetime dietary study, precedes guideline and GLP
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Details on exposure:
dietary
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 0.33%, 1.0% and 3.0%
Basis:
nominal in diet
No. of animals per sex per dose:
15

Results and discussion

Results of examinations

Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
transiently decreased body weight
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
transiently decreased food consumption
Histopathological findings: neoplastic:
no effects observed
Details on results:
No adverse effect; no carcinogenicity noted using the available technology at the time of the study.
Body weight data showed that males in the high-dose group had transiently lower weights, but there were no significant differences between the growth of TEC treated animals and control animals for the high-dose females or either sex in the low- and mid-dose groups. The effect in high-dose males may be attributable to their lower food consumption as compared to males in the other dose groups. There were no significant differences observed between treated and control groups for clinical evaluations or mortality. There were no significant differences between the groups for the following blood examinations: hemoglobin, erythrocyte count, nonprotein nitrogen and sugar determination. Urine tests for reaction, albumin, reducing substances and microscopic evaluation were all considered to be normal.
Terminal and interim autopsies disclosed no findings that were significant or attributable to TEC treatment. Size and weight of organs of the principal tissues at the time of autopsy were unremarkable. There were no significant differences between treated and control animals in comparison to the pathological findings.
Relevance of carcinogenic effects / potential:
In rats fed a diet of up to 3% triethyl citrate for two years (lifetime), there were increases in the incidence of neoplastic disease.

Effect levels

Dose descriptor:
NOAEL
Effect level:
600 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: 3% = 600 mg/kg bw/d. Initial doses were from 0.2 to 2.0 g/kg bw/d, as reviewed by JECFA. The 2.0 g/kg bw/d concentration was chosen by JECFA as the point of departure for risk assessment.
Remarks on result:
other: Effect type: carcinogenicity (migrated information)

Applicant's summary and conclusion