Tributyl O-acetylcitrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute 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:

other: Older study: meets scientific standards with acceptable restrictions (limited number of animals in study, partly limited documentation)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1959

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1959

Materials and methods

Test guideline

Qualifier:

no guideline available

Guideline:

other: Study from 1959 (no guidelines available at the time the study was performed)

Deviations:

not applicable

GLP compliance:

no

Remarks:

Study from 1959 (GLP was not compulsory at the time the study was performed)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

not specified

Details on test material:

Name of test material (as cited in study report): Acetyl tributyl citrate (CAS RN 77-90-7)
Analytical purity: not stated

Test animals

Species:

rat

Strain:

Wistar

Sex:

not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

Single dosing with 10 - 30 mL/kg (ca. 10.5 - 31.5 g)

No. of animals per sex per dose:

Dosed was a group of 5 animals (no further details reported)

Control animals:

not specified

Details on study design:

Duration of observation period following administration: 21 d
Frequency of observations and weighing: not reported
Necropsy of survivors performed: not reported
Other examinations performed: body weight,organ weights, histopathology

Statistics:

Not further specified

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 31 500 mg/kg bw

Remarks on result:

other: Endpoint was estimated, as there were no signs of toxicity to be found at test doses

Mortality:

No deaths occured at any dose level throughout the study.

Clinical signs:

other: Shortly after administration, the material began to leak from the rectum. Transient sluggishness was reported.

Gross pathology:

Not reported

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category V

Remarks:

Migrated information

Conclusions:

In this older study with Wistar rats the LD50 was estimated with > 30 mL/kg (ca. 31500 mg/kg)

Executive summary:

In this older study Wistar rats were dosed once with 10 - 30 mL/kg (ca. 10500 - 31500 mg/kg) via gavage. All animals were observed for signs of toxicity for 21 d following dosing. The dosing caused no deaths and the estimated LD50 was given with > 30 mL/kg (ca. 31500 mg/kg).