Registration Dossier

Diss Factsheets

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

Constituent 1
Chemical structure
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
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
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.