Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane- l,2-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 2015-September 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study under GLP

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)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane- l,2-diol

EC Number:

500-109-8

EC Name:

Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane- l,2-diol

Cas Number:

43011-20-7

IUPAC Name:

Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane- l,2-diol

Constituent 2

Reference substance name:

BECKOPOX™ EH 694

IUPAC Name:

BECKOPOX™ EH 694

Test material form:

solid: crystalline

Details on test material:

Test Item: BECKOPOX™ EH 694
Lot Number: 310044522
CAS Number: 43011-20-7
Manufacturer: Allnex Italy
Appearance: Pale Granules
Composition: 2-{[(1,3-dioxo-1,3-dihydro-2-benzofuran-5-yl)carbonyl]oxy}ethyl 1,3-dioxo-1,3-dihydro-2-bezofuran-5-carboxylate
Expiry Date- 05.11.2015

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Source: Velaz Prague, Czech Republic.
6 females, 8-12 weeks, non-pregnant and nulliparous.
Acclimation for 5 days.
The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, with Lignocel S3/4 bedding (Lufa-ITL GmbH, Germany). Room temperature was 22 +/- 2 degrees C, relative humidity was 55 +/1 10%., 12/12 h light/dark phase.
A laboratory food Altromin (Altromin Spezialfutter GmbH, Germany) was offered in recommended doses each day approximately at the same time
The animals received tap water fit for human consumption. Supply of drinking water was unlimited.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

The test item was administered initally to 3 animals in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water was withheld overnight). Following the period of fasting, the animals were weighed and the test item administered. After the test item had been administered, food was withheld for an additional 3-4 hours. After a 24-hour observation period of the first dosed group showed no mortality, a second group of 3 animals were treated with the same dose.

Doses:

A limit dose of 2000 mg/kg was used as a starting dose.

No. of animals per sex per dose:

One group of 3 females was dosed at 2000 mg/kg. When test item mortality was not observed, another 3 females were treated at the same dose.

Control animals:

no

Details on study design:

Animals were observed individually immediately after administration of the test item and then 0.5, 1, 2 and 4 h later. Each animal was inspected daily for the next 14 days for changes in the following systems: skin and fur, eyes and mucous membranes, respiratory and circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour patterns. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethary, sleep and coma. Body weights of animals were determined shortly before the the test item was administered and weekly thereafter. Weight differences after the first and second weeks were calculated and recorded.
All animals were subjected to a gross necropsy, including careful examination of the external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes were recorded for each animal.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no adverse effects or mortality observed in any animal

Mortality:

No mortality was observed during the study. 6/6 females survived the limit dose of 2000 mg/kg.

Clinical signs:

No mortality was observed during the study. Animals lived through observation period without important visible signs of intoxication. Neither change of health nor negative reactions were registered.

Body weight:

Body weights of all animals increased during the 14-day study.

Gross pathology:

No macroscopic changes were noticed during necropsy.

Any other information on results incl. tables

Beckopox^TM EH 694 was tested in an OECD Guideline 423 test with a limit dose of 2000 mg/kg bw. No deaths or adverse effects occurred, and the LD₅₀ is greater than 2000 mg/kg bw. It can be concluded that the substance is not classified according to Regulation EC No. 1272/2008.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

BECKOPOX™ EH 694 has a LD50 value greater than 2000 mg/kg, after single oral administration to Wistar rats.