1,2,4-Benzenetricarboxylic acid, mixed lauryl and octyl triesters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30.4.2015 - 21.5.2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Remarks:

Health Care Inspectorate of Health, Welfare and Sport, Den Haag, The Netherlands

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2,4-Benzenetricarboxylic acid, mixed dodecyl and octy triesters

IUPAC Name:

1,2,4-Benzenetricarboxylic acid, mixed dodecyl and octy triesters

Constituent 2

Reference substance name:

tris(mixed dodecyl and octyl)benzene-1,2,4-tricarboxylate

EC Number:

700-342-7

Cas Number:

1163775-81-2

Molecular formula:

C14H47O6 to C18H55O6

IUPAC Name:

tris(mixed dodecyl and octyl)benzene-1,2,4-tricarboxylate

Constituent 3

Reference substance name:

Linplast 812 TM

IUPAC Name:

Linplast 812 TM

Specific details on test material used for the study:

N/A

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Beijing Vital Rive Laboratory Animal Technology Co., Ltd., China
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 193 - 212 g
- Fasting period before study: overnight
- Housing: Animals were raised in suspended, stainless steel cages (32x28x20cm) on cage racks (167x70x171 cm). There were 10 cages per layer, and 4 layers per rack. Animals were housed individually during the test.
- Diet (e.g. ad libitum): sterilized diet with complete nutrition supplied by Beijing keaoxieli Feed Co., Ltd.
- Water (e.g. ad libitum): was purified by HT-R01000 purity system, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1 - 24.1
- Humidity (%): 44 - 69
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2015-04-30 To: 2015-05-21

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Formulations were gavaged to animals' stomach using a standard gavage tube attached to a disposal syringe. Each animal was dosed once. The dosing volume was calculated according to the fasted body weight weighed before dosing. After the test item had been administered, food would be withheld for a furher 3-4 hours.
DOSAGE PREPARATION: test substance was applied undiluted

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once in the first 30 minutes and at 1,2 and 4 hours after dosing and then once each day for up to 14 days. Observation included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention had been directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma; bodyweights were determined on day of dosing (day 0) 7 and 14 days thereafter or at death.
- Necropsy of survivors performed: yes, all animals under test, included carefully eye examinations of the abdominal, thoracic organs and their contents
- Other examinations performed: no

Statistics:

The means of the body weights were calculated.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

0/6

Clinical signs:

other: no clinical effects observed

Gross pathology:

no abnormalities were found at necropsy in all animals

Other findings:

none

Any other information on results incl. tables

N/A

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results, the oral LD50 in the rats for the test item was more than than 2000 mg/kg bw.

Executive summary:

The study was performed to assess the acute oral toxicity of 1,2,4 -Benzenetricarboxylic acid, mixed dodecyl and octyl ester in Sprague Dawley rats according to OECD 423. Based on the results, the oral LD50 in the rats for the test item was more than than 2000 mg/kg bw.