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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental start date: 10 December 2012. Experimental end date: 20 December 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N4-Benzoylcytosine
EC Number:
628-907-2
Cas Number:
26661-13-2
Molecular formula:
C11H9N3O2
IUPAC Name:
N4-Benzoylcytosine
Specific details on test material used for the study:
Sponsor's identification: N-Benzoyl Cytosine
Description: off white powder
Batch number: NBC-5-11001
Purity: not supplied
Date received: 09 July 2012
Expiry date: not supplied
Storage conditions: room temperature in the dark over silica gel

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals and Animal Husbandry
Three New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals weighed 2.40 to 2.83 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, drinking water and food (2930C Teklad Global Certified Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study,
drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Free access to mainsdrinking water and food (2930C Teklad Global Certified Rabbit diet supplied by Harlan Laboratories UK Ltd., 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

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A volume of 0.1 ml of the test item, which was found to weigh approximately 63 mg
Observation period (in vivo):
72
Number of animals or in vitro replicates:
3
Details on study design:
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
Initially, a single rabbit was treated. A volume of 0.1 ml of the test item, which was found to weigh approximately 63 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test item, an assessment of the initial pain reaction was made according to the six point scale.
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation (see any other information on materials and methods) Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Any clinical signs of toxicity, if present, were also recorded.
Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48h
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48h
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48
Remarks on result:
probability of weak irritation
Other effects:
Ocular Reactions
No corneal effects were noted during the study.
Iridial inflammation was noted in all treated eyes one hour after treatment.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment.
Minimal conjunctival irritation was noted in two treated eyes at the 24-Hour observation.
One treated eye appeared normal at the 24-Hour observation and two treated eyes
appeared normal at the 48-Hour observation.

Bodyweight
One animal showed a slight bodyweight loss and two animals showed expected gain in
bodyweight during the study.

Any other information on results incl. tables

Individual Eye Reactions

Rabbit Number and Sex 72779 Male 72797 Male 72798 Male
Initial pain reaction = 2  Initial pain reaction = 2  Initial pain reaction = 2 
Time after treatment (hours) 1 24 48 72 1 24 48 72 1 24 48 72
Degree of Opacity 0 0 0 0 0 0 0 0 0 0 0 0
Iris 1 0 0 0 1 0 0 0 1 0 0 0
Conjunctivae redness 2 0 0 0 2 1 0 0 2 1 0 0
Chemosis 2 0 0 0 2 1 0 0 2 1 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not produce mean scores following grading at 24, 48 and 72 hours for corneal opacity ≥ 1, iritis ≥ 1, conjunctival redness ≥ 2 or conjunctival oedema (chemosis) ≥ 2, as such it does not meet the requirements to be classified as a irritant to the rabbit eye according to CLP.
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:

OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002) 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 three rabbits produced iridial inflammation and moderate conjunctival irritation. One treated eye appeared normal at the 24-Hour observation and two treated eyes appeared normal at the 48-Hour observation.

Conclusion

The test item did not produce mean scores following grading at 24, 48 and 72 hours for corneal opacity ≥ 1, iritis ≥ 1, conjunctival redness ≥ 2 or conjunctival oedema (chemosis) ≥ 2, as such it does not meet the requirements to be classified as a irritant to the rabbit eye according to CLP.