Triethyl O-acetylcitrate

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1959

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Toxicology of the Citric Acid Esters: Tributyl Citrate, Acetyl Tributyl Citrate, Triethyl Citrate, and Acetyl Triethyl Citrate

Author:

Finkelstein M & Gold H

Year:

1959

Bibliographic source:

Toxicol Applied Pharmacol 1, 283 - 298

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1959

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Repeated exposure via diet.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Triethyl O-acetylcitrate

EC Number:

201-066-5

EC Name:

Triethyl O-acetylcitrate

Cas Number:

77-89-4

Molecular formula:

C14H22O8

IUPAC Name:

triethyl 2-acetoxypropane-1,2,3-tricarboxylate

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not reported
- Age at study initiation: 21 days
- Weight at study initiation: not reported
- Fasting period before study: not reported
- Housing: not reported
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not reported

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DIET PREPARATION
- Rate of preparation of diet (frequency): not detailed
- Mixing appropriate amounts with (Type of food): Basal laboratory rat diet

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Six weeks, plus 2 weeks recovery

Frequency of treatment:

Continually, ad libitum

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0.5 other: % in diet

Remarks:

approximate daily consumption of 1 g/kg in the early part of the experiment

Doses / concentrations 2

Dose / conc.:

1 other: % in diet

Remarks:

approximate daily consumption of 2 g/kg in the early part of the experiment

Doses / concentrations 3

Dose / conc.:

2 other: % in diet

Remarks:

approximate daily consumption of 4 g/kg in the early part of the experiment

No. of animals per sex per dose:

4 animals per sex per dose

Control animals:

yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:

Body weights were measured initially and weekly until study completion
CAGE SIDE OBSERVATIONS: Performed, as clinical signs were described

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: weekly

Sacrifice and pathology:

Not reported

Other examinations:

Not reported

Statistics:

No statistics were performed, because the sample size was very small

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

effects observed, treatment-related

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Details on results:

None of the three test concentrations of Acetyl Triethyl Citrate had any effect on growth and the test substance did not induce toxicity. Ingestion of Acetyl TriethylCitrate also had no effect on red blood cell count, white blood cell count, or differential blood count.

Effect levels

Dose descriptor:

NOEL

Effect level:

>= 2 other: % in diet

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no effects observed

Remarks on result:

not determinable due to absence of adverse toxic effects

Target system / organ toxicity

Critical effects observed:

no

Applicant's summary and conclusion

Conclusions:

The NOEL was at a dietary concentration of 2%, which is equal to 4000 mg/kg.

Executive summary:

ATEC was fed to rats for 6 weeks as dietary admixture at a 0.5, 1 and 2% level. Control animals received plane diet without test item. No effects were observed at dietary levels up to 2%.