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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4.2.2015-13.8.2015

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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

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

Test type:

standard acute 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:

male/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: 245-268 g (males), 224-243 g (females)
- Housing: Animals were raised in suspended, stainless steel cages (32x28x20cm) on cage racks (16 7x70x171 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): drinking water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1 ± 24
- Humidity (%): 44-69
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2015-04-30 To: 2015-05-19

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the test animals by shaving. Care was taken to avoid abrading the skin, which could alter its permeability.
Each animal was dosed once and only animals with healthy and intact skin were used.
The gauze with the test item was placed uniformly over the treatment area and semi-occluded with a piece of self-adhesive bandage. Shortly after dosing the dressing should be examined to ensure that the animals cannot ingest the test item.
- Area of exposure: dorsal surfaces of the trunk (clear area 40 cm²)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, at the end of exposure period for approximately 24 hours, residual test item was removed by cotton wool soaked in water.


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Because the test item was liquid, before administration calculate the theoretical test item used for each animal in accordance with the design of dose and animal body weight. The mean density was 941 mg/L.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

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 tr emors, convulsions, salivation, diarrhoea, lethargy, sleep and coma; bodyweights were determined on day of dosing (day 0) 7 and 14 days thereafter or at death.
- Skin irritation: Adverse skin reactions at the site of application were recorded daily following the removal of the dressings.
- Necropsy of survivors performed: yes, all animals under test, included carefully eye examinations of the abdominal, thoracic organs and their contents

Statistics:

not performed

Results and discussion

Preliminary study:

N/A

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 3

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occurred

Clinical signs:

other: no clinical signs were observed

Gross pathology:

No abnormalities found.

Other findings:

No signs of dermal irritation.

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 acute dermal LD50 in rats for 1,2,4-Benzenetricarboxylic Acid, mixed dodecyl and octyl triesters for male rats was > 2000 mg/kg and for female rats also > 2000 mg/kg.

Executive summary:

The study was performed to assess the acute dermal toxicity of 1,2,4 -Benzenetricarboxylic acid, mixed dodecyl and octyl triesters in Sprague Dawley rats according to OECD 402. At test at one dose level of 2000 mg/kg bw was carried out in a group of 10 animals (5 males and 5 females). Clinical observations were made during the first 30 minutes, and at 1,2, and 4 hours after dosing and then once each day for up to 14 days. Individual weights of animals were determined at grouping, day 0 (day of dosing), on day 7 and 14. At the end of the test, a gross necroscopy was performed on all animals under test. There were not deaths of moribund during the test. There were no abnormal findings in all animals after dosing from the first day until the end of the test. There were no signs of dermal irritation. One animal showed a small decrease in body weight during the second week.

Based on the results, the acute dermal LD50 in rats for 1,2,4-Benzenetricarboxylic Acid, mixed dodecyl and octyl triesters for male rats was > 2000 mg/kg and for female rats also > 2000 mg/kg.