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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
existing study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental phase 21 April to 08 May 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 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Two New Zealand White rabbits were used for the study. At the start of the study the animals weighed 2.17 to 2.33 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 (Certified Rabbit Diet) 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

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml which weighed approximately 65mg
Duration of treatment / exposure:
one application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2 male rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 0, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 0, 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
10
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
10
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
4
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 48, 72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

Both animals showed expected body weight gains during the study.

No corneal or iridial effects were noted during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item produced a maximum group mean score of 10.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed to be compatible with the following:

1) OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 April 2002)

      

2) Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008

Result

A single application of the test item to the non-irrigated eye of two rabbits produced a moderate conjunctival irritation. All treated eye appeared normal at the 48‑hour observation.

Conclusion

The test item produced a maximum group mean score of 10.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.