Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate

EC Number:

222-020-0

EC Name:

Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate

Cas Number:

3319-31-1

Molecular formula:

C33H54O6

IUPAC Name:

tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): 1,2,4 Tris benzenetricarboxylic acid (2-ethylhexyl) ester
- Analytical purity: 99.0%
- Lot/batch No.: 60601
- Stability under test conditions: room temperature
- Storage condition of test material: kept in the dark at room temperature until use
- Other: stored in fridge for 7 days

Test animals

Species:

rat

Strain:

other: Crj:CD (SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Japan
- Age at study initiation: 5 w
- Weight at study initiation: during treatment; males: 149-163 g; females: 126-140 g
- Fasting period before study:
- Housing: 5 same sex in stainless steel breeding cages
- Diet (e.g. ad libitum): yes, Oriental Yeast Co. Ltd, pelleted diet
- Water (e.g. ad libitum): yes drinking water
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23+/- 2 degrees C
- Humidity (%): 55+/- 10
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12: 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40% w/v
- Amount of vehicle (if gavage): 5 ml/kg
- Justification for choice of vehicle: TOTM is soluble in oil
- Lot/batch no. (if required): No batch no. but supplied by Nakaraitesuku
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: 5.0 ml/kg

DOSAGE PREPARATION (if unusual): liquid mixed with oil

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 3 preliminary studies performed previously

Doses:

2000 mg/kg; in preliminary study 200 and 2000 mg/kg did not cause mortality.

No. of animals per sex per dose:

5 males & 5 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days (or other?) 14d
- Frequency of observations and weighing: frequently for 6h on day of dosing then twice daily
- Necropsy of survivors performed: yes/no: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: clinical signs, body weight, macroscopic pathology

Statistics:

Not required as a limit test

Results and discussion

Preliminary study:

In preliminary study 200 and 2000 mg/kg did not cause mortality.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths occurred

Mortality:

None in controls or TOTM group

Clinical signs:

other: Loose stools were seen in both control and TOTM groups from 1-4h after dosing. The incidence was similar in both groups

Gross pathology:

There were no differences between the incidence of findings in the control & TOTM groups.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 was established at > 2,000 mg/kg for both sexes.

Executive summary:

Acute oral toxicity (LD50) in the rat is in excess of 2000 mg/kg