5,5'-sulfonylbis(2-benzofuran-1,3-dione)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-02-04 to 2015-03-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 2001-12-17

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

, signed 2014-05-14

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5,5’-sulfonylbis(2-benzofuran-1,3-dione)

IUPAC Name:

5,5’-sulfonylbis(2-benzofuran-1,3-dione)

Constituent 2

Reference substance name:

807-101-6

EC Number:

807-101-6

IUPAC Name:

807-101-6

Constituent 3

Reference substance name:

5,5'-sulfonylbis(2-benzofuran-1,3-dione)

Cas Number:

2540-99-0

Molecular formula:

C16H6O8S

IUPAC Name:

5,5'-sulfonylbis(2-benzofuran-1,3-dione)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): 4,4’-Sulfonyldiphthalic acid dianhydride (DSDA)
- Molecular formula: C16H6O8S
- Molecular weight: 358.28 g/mol
- Physical state: solid powder, beige, odourless
- Storage condition of test material: ambient temperature, dark, dry, in original container in a well-ventilated place

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 172 - 188 g
- Fasting period before study: feeding was discontinued approx. 16 hours before administration
- Housing: granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages; animals were kept in groups of 3 animals in MAKROLON cages (type III plus)
- Diet: commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum): drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C (maximum range)
- Humidity: 55% ± 15% (maximum range)
- Air changes: 12 to 18-fold air change/hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.8% aqueous hydroxypropylmethylcellulose

Details on oral exposure:

VEHICLE
- Vehicle: 0.8% aqueous hydroxypropylmethylcellulose (Fagron GmbH & Co., 22885 Barsbüttel, Germany)
- Lot/batch no.: batch no. 13 D03-N03 (Methocel)

MAXIMUM DOSE VOLUME APPLIED: 10mL/kg b.w.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed before and immediately, 5, 15, 30 and 60 minutes, as well as 3, 6 and 24 hours after administration
During the follow-up period of two weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on prematurely deceased animals were made at least once daily to minimize loss of animals during the study. The time of death would have been recorded as precisely as possible. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.

- Necropsy of survivors performed: yes

Statistics:

No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).
The LD50 value was ranked exceeding 2000 mg/kg body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

A single oral administration of 2000 mg 4,4’-Sulfonyldiphthalic acid dianhydride (DSDA)/kg b.w. did not reveal any signs of toxicity.

Body weight:

All animals gained the expected body weight at the end of the study.

Gross pathology:

No signs of abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 (female rats) > 2000 mg/kg b.w..
According to the Regulation (EC) No 1272/2008 and subsequent regulations the test material does not require classification as acute toxic via oral route.
According to the Directive 67/548/EEC and its subsequent amendments, the test material does not require classification as acute toxic via oral route.