2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione

EC Number:

233-701-7

EC Name:

2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione

Cas Number:

10319-14-9

Molecular formula:

C18H10BrNO3

IUPAC Name:

2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

not specified

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

0.5 g of tested substance was mixed with 0.5 ml distilled water before application to skin

Duration of treatment / exposure:

72 hours

Observation period:

24 and 72 h

Number of animals:

6

Details on study design:

The procedure employed was that prescibed by the consumer product safety commission of the U.S.A. in the code of federal regulations, title 16, section 1500.41.
Following the regulations, it is a patch-test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. A minimum of six subjects are used in abraded and intact skin tests. Introduce under a square patch, such as surgical gauze measuring 1 inch by 1 inch and two single layers thick, 0.5 milliliter (in the case of liquids) or 0.5 gram (in the case of solids and semisolids) of the test substance. Dissolve solids in an appropriate solvent and apply the solution as for liquids. The animals are immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material, such as rubberized cloth, for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours of exposure, the patches are removed and the resulting reactions are evaluated on the basis of the designated values

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #6

Time point:

24/48/72 h

Score:

ca. 0.66

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: intact and abraded skin

Results 2

Irritation parameter:

erythema score

Basis:

animal: #2, #3, #4, #5

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

other: intact and abraded skin

Results 3

Irritation parameter:

edema score

Basis:

animal: 1-6

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

other: intact and abraded skin

Irritant / corrosive response data:

Very slight erythema was observed in the intact and abraded sites of two animals at the 24 hours reading only. the reaction had ameliorated by the 72hours reading.
Fours animals did not show any observable response to treatment throughout the 72 hours observation period.

Any other information on results incl. tables

In the test report, skin reaction scores at 0 h and 72 h after patch removal are given. For the purposes of calculating erythema and oedema scores at non-given time points (after patch removal), the following is done: - scores at 24 h are taken also as scores at 48 h. The mean skin reaction scores are calculated from values at 24, 48 and 72 h after patch removal.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to CLP regulation (EC 1272/2008)

Conclusions:

not skin.irritant

Executive summary:

The substance was tested for skin irritation potential using the patch test technique described in the consumer product safety commission of the U.S.A. in the code of federal regulations, title 16, section 1500.41.

In the test report, skin reaction scores at 0 h and 72 h after patch removal are given. For the purposes of calculating erythema and oedema scores at non-given time points (after patch removal), the following is done: - scores at 24 h are taken also as scores at 48 h. The mean skin reaction scores are calculated from values at 24, 48 and 72 h after patch removal.

Intact and abraded skin showed no skin reactions at all for oedema; 2/6 rabbits show very slight edema at 24h, but this skin reactions were reversible within 72h.

For all animals, the calculation of mean skin reaction scores (24, 48 and 72 h) after patch removal gave the following values for intact skin: erythema score abraded and intact skin <1 and oedema score = 0 for abraded and intact skin.

Therefore, the test substance is a non-skin irritant.