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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study was performed between 2002-05-09 and 2002-05-29. Study report signed off 2002-12-23.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
443-510-2
EC Name:
-
Cas Number:
738587-10-5
Molecular formula:
C26H14N10Ni2O18S4 as free acid
IUPAC Name:
dinickel(2+) sodium 3-carboxy-5-[(1E)-2-(7-oxido-2,6-disulfonaphthalen-1-yl)diazen-1-yl]-1H-1,2,4-triazol-1-ide 3-carboxy-5-[(1E)-2-(7-oxido-2-sulfo-6-sulfonatonaphthalen-1-yl)diazen-1-yl]-1H-1,2,4-triazol-1-ide
Details on test material:
Nature of substance: crystalline solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three New Zealand White rabbits were supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK. At the start of the study the animals were in the weight range of 2.0 to 3.5 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 metal 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.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye remained untreated and was used for control purposes
Amount / concentration applied:
A volume of 0.1ml of the test substance which was found to weigh approx. 88mg.
Duration of treatment / exposure:
single application
Observation period (in vivo):
7 days (observations at 1, 24, 48, 72 hours and 7 days)
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, 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 a 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 given in (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49). Any other ocular effects were also noted. Examination of the eye was facilitated by the use of a light source from a standard ophthalmoscope.

An additional observation was made on day 7 to assess the reversibility of the ocular effects.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: (redness)
Basis:
animal: 140 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Pink staining prevented evaluation of conjunctival redness at 1h
Irritation parameter:
other: (redness)
Basis:
animal: 60 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Pink staining prevented evaluation of conjunctival redness at 1h and 24h.
Irritation parameter:
other: (redness)
Basis:
animal: 79 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Pink staining prevented evaluation of conjunctival redness at 1h and 24h.
Irritation parameter:
chemosis score
Basis:
animal: 140 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal: 60 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal: 79 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
cornea opacity score
Basis:
animal: Male 140
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Pink staining prevented evaluation of cornea at 1h and 24h
Irritation parameter:
cornea opacity score
Basis:
animal: 60 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Pink staining prevented evaluation of cornea at 1h and 24h
Irritation parameter:
cornea opacity score
Basis:
animal: 79 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Pink staining prevented evaluation of the cornea at 1h and 24h.
Irritation parameter:
iris score
Basis:
animal: 140 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Pink staining prevented evaluation of the iris at 1h and 24h
Irritation parameter:
iris score
Basis:
animal: 60 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Pink staining prevented evaluation of the iris at 1h and 24h.
Irritation parameter:
iris score
Basis:
animal: 79 male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Pink staining prevented evaluation of the iris at 1h and 24h.
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
Pink-coloured staining was noted in all treated eyes at the 1, 24 and 48 hour observations and persisted in two treated eyes at the 72 hour observation.

Staining prevented evaluation of corneal and iridial effects in all treated eyes at the 1 and 24h observations and the evaluation of conjunctival redness in all treated eyes at the 1h observation and in two treated eyes at the 24h observation.

Slight to moderate conjunctival chemosis and severe discharge were noted in all treated eyes at the 1h observation period. Minimal chemosis and discharge were noted in two treated eyes at the 24h observation. Moderate conjunctival irritation was apparent in one treated eye at the 24h observation. Mininal conjunctival irritation was apparent in all treated eyes at the 48 and 72h observations.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
The test substance produced a maximum group mean score in the range of 10.7 to 106.7 and was considered to be at least a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye according to the modified Kay and Calandra classification system. Staining of the eyes was reversible within 7 days. The test substance does not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC and Regulation (EC) No. 1272/2008.

The test substance did not meet the criteria for classification as an irritant according to EU labelling regulations (Regulation EC No. 1272/2008 and Directive 2001/59/EC)
Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test substance 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 February 1987)

Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 92/69/EEC

Result & Conclusion

The test material produced a maximum group mean score in the range of 10.7 to 106.7 and was considered to be at least a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC and Regualtion (EC) No. 1272/2008.