Tributyl benzene-1,2,4-tricarboxylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted in accordance with internationally recognised test methods. For read across justification see Section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trioctyl trimellitate

IUPAC Name:

Trioctyl trimellitate

Details on test material:

- Name of test material (as cited in study report): Trioctyl benzene-1,2,4-tricarboxyiate
- Molecular formula (if other than submission substance): C33 H54 O6
- Molecular weight (if other than submission substance): 546.79
- Smiles notation (if other than submission substance): O=C(OCCCCCCCC)c(ccc(c1C(=O)OCCCCCCCC)C(=O)OCCCCCCCC)c1
- InChl (if other than submission substance): 1S/C27H42O6/c1-3-5-7-9-11-12-14-16-20-33-27(31)23-18-17-22(21-24 (23)25(28)29)26(30)32-19-15-13-10-8-6-4-2/h17-18,21H,3-16,19-20H2,1-2H3, (H,28,29)
- Structural formula attached as image file (if other than submission substance): see 89-04-3 structure.png

- Physical state: liquid
- Analytical purity: => 99.0%
- Lot/batch No.: C-120
- Stability under test conditions: Stated to be stable
- Storage condition of test material: Ambient conditions

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 weeks
- Weight at study initiation: males: 116-127 g; females: 97-108 g
- Fasting period before study: 18 hours
- Housing: 5 same sex in stainless steel breeding cages
- Diet (e.g. ad libitum): yes, except during pre-dose fasting period
- Water (e.g. ad libitum): yes
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23+/- 2 degrees C
- Humidity (%): 55+/- 10
- Air changes (per hr): 15
- 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: 20% w/v
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Substance is not miscible in aqueous vehicles but is water miscible in oil

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual): liquid test substance mixed with vehicle

Doses:

2000 mg/kg (based on findings of preliminary study in which doses of 1000 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
- Frequency of observations and weighing: frequently for 6 hours on day of dosing then daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weight - Days 1, 2, 4, 8, 11 and 15

Statistics:

Student t-test applied to bodyweight data control vs. test groups

Results and discussion

Preliminary study:

In preliminary study 1000 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 test group

Clinical signs:

other: Mucoid faeces were seen in animals from both control and test groups 1-3 hours after dosing. The incidence between groups was similar.

Gross pathology:

There were no abnormalities noted in any animal from either control or treatment group.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose (LD50) in the rat was established at > 2,000 mg/kg for both sexes.

Executive summary:

Acute oral toxicity has been investigated in the rat using methods decribed in OECD TG 401. No mortality or effects of treatment occurred following administration of a single dose at a level of 2000 mg/kg body weight. The median lethal dose (LD50) in the rat is therefore in excess of 2000 mg/kg