4,4'-(3-cyano-4-methylpyridine-2,6-diyl)bis(azanediyl)dibenzenesulfonic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

existing study

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 14 April 2010 and 17 April 2010. Report issued: 24 August 2010.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-({5-cyano-4-methyl-6-[(4-sulfophenyl)amino]pyridin-2-yl}amino)benzene-1-sulfonic acid

EC Number:

687-668-2

Cas Number:

815676-09-6

Molecular formula:

C19H16NO6S2

IUPAC Name:

4-({5-cyano-4-methyl-6-[(4-sulfophenyl)amino]pyridin-2-yl}amino)benzene-1-sulfonic acid

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

impurity 1

Reference substance name:

Tetrahydrothiophene 1,1-dioxide

EC Number:

204-783-1

EC Name:

Tetrahydrothiophene 1,1-dioxide

Cas Number:

126-33-0

Molecular formula:

C4H8O2S

IUPAC Name:

Sulfolane

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Two New Zealand White rabbits were supplied by Harlan Laboratories UK Ltd, Hillcrest,Belton, Loughborough, UK. At the start of the study the animals weighed 2.44 or 2.53 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.

The animals were individually housed in suspended cages. Free access to mains drinking water and food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: Test material moistened with 0.5 ml of distilled water to achieve a dry paste.

Controls:

no

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

4 hours

Observation period:

Immediately following removal of the patches and approximately 1, 24, 48 and 72 (performed approximately 67%) hours later, the test sites were examined for evidence of primary irritation and scored accordingly.

Number of animals:

2 rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Any other information on results incl. tables

See attachment in background information.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)

Method 64 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008

Method

The test substance was administered as single 4-hour, semi-occluded application of the test material to the intact skin of two rabbits.  Test sites were examined and scored for effects immediately following removal of the patches and at approximately 1, 24, 48 and 72 hours.

Conclusion

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.