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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 January 2015-05 March 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 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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:

Name:ZAN 573
Batch/Lot number:130072591
Description:Yellow to brown coarse powder
Molecular formula:C21H12O10
Molecular weight:424.314 g/mol
Purity:100%
Manufacture date:24 January 2014
Expiry date:24 January2016
Storage condition: Controlled room temperature (15-25°C, below 70 RH%)
Safety precautions:Routine safety precautions (gloves, goggles, face mask, lab coat) for unknown materials were applied to assure personnel health and safety

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species and strain:New Zealand White rabbits
Source:S&K-LAP Kft.2173 Kartal, Császár út 135, HUNGARY
Justification of strain:The New Zealand White albino rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health:Only animals in acceptable health condition were used for the test.
Number of animals:3
Age of animals at treatment:~12 weeks old
Sex:Male
Body weight range at the beginning of the life phase: 3191-3823 g
at the end of the life phase: 3256-3925 g
Date of receipt: 30 December 2014
Acclimation time: 15days

Lighting periods; 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature range during the study: 20 ± 3 °C
Relative humidity during the study: 25-34 %
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
Ventilation: 15-20 air exchanges/hour

The animals received standard diet for rabbits produced by Cargill Takarmány Zrt., H- 5300 Karcag, Madarasi út, Hungary, ad libitum. Animals were provided with the following batch: Y 0550 11 14 0014, expiry date: 26 February 2015
Tap water was provided ad libitum.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

The test item was used as a single dose of 0.5 g, applied to the test area.

Duration of treatment / exposure:

Four hours after application, the test item was removed by gently washing with body temperature water.

Observation period:

Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes and then at 24, 48 and 72 hours after patch removal

Number of animals:

3

Details on study design:

Approximately 24 hours prior to the test, the hair was clipped from the back and flanks of the animals. Removal of hair was performed in two steps. The majority of hair was clipped with an electronic hair clipper and the remaining hair was moistened with water and shaved with a razor.

The test item was applied to an approximately 6 cm² area of intact skin as follows:
• A single layer of a fine medical gauze (open-weave with large holes) of approximately 5x5 cm was placed over the application area,
• The appropriate amount of test item was carefully spread over the application area (the gauze helped maintain the test item in place),
• Three more layers of gauze were placed over the test item,
• These gauze patches were kept in contact with the skin by a patch of clear plastic with a surrounding adhesive hypoallergenic plaster to ensure continued good contact between the moistened test item and the shaved skin.
• The entire trunks of the animals were wrapped with plastic wrap for 4 hours.
• Medical elastic tubing was placed over the plastic to keep it in place.

Initially, a single animal was treated. As neither a corrosive effect nor a severe irritant effect were observed after the 1-hour observation, the test was completed using the 2 remaining animals with the same dose and an exposure period of 4 hours.

Four hours after application, the test item was removed by gently washing with body temperature water.

Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes and then at 24, 48 and 72 hours after patch removal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: no irritation observed

Results 2

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: no irritation observed

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: no irritation observed

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: no irritation observed

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: no irritation observed

Irritant / corrosive response data:

No irritation observed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

ZAN 573 is not irritating to the skin of rabbits, according to OECD 404 testing.