5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, polymer with 1,2-propanediol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-2015

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)

GLP compliance:

yes (incl. QA statement)

Test type:

other: limit test

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1,2-propanediol

EC Number:

613-407-9

Cas Number:

63948-88-9

Molecular formula:

not applicable

IUPAC Name:

5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1,2-propanediol

Constituent 2

Reference substance name:

ZAN 573

IUPAC Name:

ZAN 573

Test material form:

solid: particulate/powder

Details on test material:

Product name: ZAN 573, 100% purity (UVCB)
Chemical name: 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-,
polymer with 1,2-propanediol (85%) and Trimellitic anhydride (15%)
CAS numbers : 63948-88-9: 85% and 552-30-7: 15%
Batch number: 130072591
Appearance: Yellow to brown solid, coarse powder
Purity: treated as 100% (for more details see above)
Manufacturing date: 24 January 2014
Expiry date: 24 January 2016
Storage conditions: Controlled room temperature (15-25°C, below 70 RH%)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:CRL, RMS Germany Gmbh, Sandhofer Weg 7, D-97633 Sulzfeld.
- Age at study initiation:
- Weight at study initiation: males 221-251 g, females: 208-236 g.
- Fasting period before study: no data
- Diet (e.g. ad libitum): ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance". ssniff Spezialdiäten GmbH, D-59494 Soest Germany (Batch no.: 190 1786, expiry date: January 2015), ad libitum,
- Water): tap water from the municipal supply, ad libitum.
- Acclimation period: 6 days
- Housing: Individual caging
- Cage type: Type II. polypropylene/polycarbonate
- Bedding: Lignocel Bedding for Laboratory Animals was available to animals during the study.
- Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
- Temperature: 20.5 – 25.0 °C
- Relative humidity: 42 – 68 %
- Ventilation: 15-20 air exchanges/hour
- Enrichment: Rodents were housed with deep wood sawdust bedding to allow digging and other normal rodent activities.



IN-LIFE DATES: From:15 October 2014 To: 29 Oct 2014.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

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 per day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

The back of each animal was shaved (approximately 10 % area of the total body surface) approximately 24 hours prior to treatment. The test item was applied as a single dose as supplied to the shaved skin and remained in contact with the skin for the 24-hour exposure period. A sufficient amount of water was used to dampen the test material to ensure good contact with the skin. Sterile gauze pads were placed on the skin of rats to cover the test item. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours.

At the end of the exposure period, the area of skin treated with the test item was washed with water of body temperature.

Macroscopic examination was performed on all animals. All animals were anaesthetised with Euthasol® 40 % (details in 3.1.3.) and exsanguinated. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes were recorded.

Statistics:

none

Results and discussion

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 observed

Mortality:

no deaths

Clinical signs:

other: Erosion of the skin with crust formation: 2/5 males, 1/5 females Oedema of the skin: 1/5 males, 1/5 females Erythema in 1/5 females

Gross pathology:

No adverse effects were seen which are attributable to test material exposure.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity test in Wistar rats, the LD50 of ZAN 573 was greater than 2000 mg/kg bw. The substance is not classified according to EU Regulation No. 1272/2008.