4-methyl-2,6-bis(phenylamino)nicotinonitrile

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:

Experimental phase 14 April to 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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-methyl-2,6-bis(phenylamino)pyridine-3-carbonitrile

EC Number:

810-804-0

Cas Number:

51566-48-4

Molecular formula:

C19H16N4

IUPAC Name:

4-methyl-2,6-bis(phenylamino)pyridine-3-carbonitrile

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 used for the study. At the start of the study the animals weighed 2.41 or 2.55 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 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:

occlusive

Preparation of test site:

clipped

Vehicle:

other: 0.5 ml distilled water was used to to moisten the test marterial.

Amount / concentration applied:

0.5 gram

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

2 males

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 0, 1, 24, 48, 72 h

Score:

0

Results 2

Irritation parameter:

overall irritation score

Basis:

animal #2

Time point:

other: 0, 1, 24, 48, 72 h

Score:

0

Irritant / corrosive response data:

Very slight erythema one hour after patch removal was noted in both animals. No corrosive effects were noted.

Any other information on results incl. tables

Both animals showed expected bodyweight gain during the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item 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 item to the skin of the New Zealand White rabbit. The method was designed to be compatible with the following guidelines:

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

2) Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008

Results

A single 4‑hour, semi-occluded application of the test item to the intact skin of two rabbits produced very slight erythema one hour after patch removal.

Conclusion

The test item 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.