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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:
2013-11-04 to 2013-11-18
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:
2014
Report date:
2014

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

Test material

Constituent 1
Chemical structure
Reference substance name:
tetrasodium 1,8,15,22-tetra-(3-sulfoxypropylsulfonyl)copper phthalocyanine
EC Number:
696-145-8
Cas Number:
944730-39-6
Molecular formula:
C44H36CuN8O20S8 .4Na
IUPAC Name:
tetrasodium 1,8,15,22-tetra-(3-sulfoxypropylsulfonyl)copper phthalocyanine
Test material form:
other: solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
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 2.74 to 3.31 kg and were twelve to twenty weeks old. After an acclimatization 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 (2930C Teklad Global 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. 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:
other: left eye of test animals remained untreated and was used for control purposes.
Amount / concentration applied:
A volume of 0.1 mL of the test item, which was found to weigh approximately 89 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.
Duration of treatment / exposure:
single application
Observation period (in vivo):
Immediately after administration of the test item, an assessment of the initial pain reaction was made according to a six point scale.

Eight hours after test item application, a subcutaneous injection of post dose analgesia, buprenorphine 0.01 mg/kg and meloxicam 0.5 mg/kg, was administered to provide a continued therapeutic level of systemic analgesia. The treated animal was checked for signs of pain and suffering approximately 12 hours later. No further analgesia was required.

After consideration of the ocular responses produced in the first treated animal, two additional animals were similarly treated.

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation (Draize, J.H, 1977) Draize Scale for Scoring Ocular Irritation.
Number of animals or in vitro replicates:
3
Details on study design:
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 recorded.

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

Individual body weights 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: 73667 Male
Time point:
other: highest score at 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effect on cornea therefore not applicable
Irritation parameter:
cornea opacity score
Basis:
animal: 73718 Male
Time point:
other: highest score at 24,48 & 72h
Score:
0
Max. score:
4
Reversibility:
other: no effect on cornea therefore not applicable
Irritation parameter:
cornea opacity score
Basis:
animal: 73719 Male
Time point:
other: highest score at 24,48 & 72h
Score:
0
Max. score:
4
Reversibility:
other: no effect on cornea therefore not applicable
Irritation parameter:
iris score
Basis:
animal: 73667 Male
Time point:
other: highest score at 24, 48 & 72h
Score:
0
Max. score:
2
Reversibility:
other: no effect on iris therefore not applicable
Irritation parameter:
iris score
Basis:
animal: 73718 Male
Time point:
other: highest score at 24, 48 & 72h
Score:
0
Max. score:
2
Reversibility:
other: no effect on iris therefore not applicable
Irritation parameter:
iris score
Basis:
animal: 73719 Male
Time point:
other: highest score at 24, 48 & 72h
Score:
0
Max. score:
2
Reversibility:
other: no effect on iris therefore not applicable
Irritation parameter:
chemosis score
Basis:
animal: 73667 Male
Time point:
other: highest score at 24, 48 & 72h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal: 73718 Male
Time point:
other: highest score at 24, 48 & 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 73719 male
Time point:
other: highest score at 24, 48 & 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: redness
Basis:
animal: 73667 male
Time point:
other: highest score at 24, 48 & 72h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
other: redness
Basis:
animal: 73718
Time point:
other: highest score at 24, 48 & 72h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: redness
Basis:
animal: 73719 male
Time point:
other: highest score at 24, 48 & 72h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: discharge
Basis:
other: 73667 male
Time point:
other: highest score at 24, 48 & 72h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72h
Remarks on result:
other: blue coloured staining of fur noted around treated eye
Irritation parameter:
other: discharge
Basis:
other: 73718 male
Time point:
other: highest score at 24, 48 & 72h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24h
Remarks on result:
other: blue coloured staining of fur noted around treated eye
Irritation parameter:
other: discharge
Basis:
other: 73719 male
Time point:
other: highest score at 24, 48 & 72h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24h
Remarks on result:
other: blue coloured staining of fur noted around treated eye
Irritant / corrosive response data:
The test item produced a maximum group mean score of 6.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Other effects:
All anmials showed expected gain in body weight during the study

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information mild irritant Criteria used for interpretation of results: EU
Conclusions:
The test item produced a maximum group mean score of 6.0 and was classified as 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 item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
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. This study was designed to be compatible with the procedures indicated by the following internationally accepted guidelines and recommendations:

·     OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 02 October 2012)     

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

Results & Conclusions

The test item produced a maximum group mean score of 6.0 and was classified as 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 item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.