Trihexadecyl citrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

Study conducted before GLP was adopted in USA.

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trihexadecyl citrate

EC Number:

224-931-9

EC Name:

Trihexadecyl citrate

Cas Number:

4560-68-3

Molecular formula:

C55H106O6

IUPAC Name:

trihexadecyl citrate

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Albino (not otherwise specified).

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 218-260 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test article was used as received (sp.g. = 0.92).

Doses:

5 g/kg bw

No. of animals per sex per dose:

5 male 5 female

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 3, 6 and 24 hours and then daily
- Necropsy of survivors performed: yes
- Other examinations performed: pharmacologic activity and drug toxicity

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the study period.

Clinical signs:

other: No clinical signs were reported.

Gross pathology:

No effects were observed during necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test article was determined to have an acute oral LD50 of >5000 mg/kg bw in rats under the conditions of the test.

Executive summary:

In this study (equivalent to EPA OPPTS 870.1100), the test article was determined to have an acute oral LD50 of >5000 mg/kg bw in rats under the conditions of the test.