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EC number: 939-992-3 | CAS number: 1195028-55-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Rabbit enucleated eye test
- Version / remarks:
- ICCVAM, 2006 and 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- pentalithium(1+) pentasodium 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{3-sulfonato-4-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate
- EC Number:
- 939-992-3
- Cas Number:
- 1195028-55-7
- Molecular formula:
- Molecular formula of the main constituents: (1) C38H28N8O12S4.xLi.xNa (2) C52H38N10O18S6.xLi.xNa
- IUPAC Name:
- pentalithium(1+) pentasodium 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{3-sulfonato-4-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals were 12 to 20 weeks old. Rabbits that have previously been used in skin or eye irritation studies at the test facility may be used as eye donors. If the donor animals have been used in an eye irritation study, only the untreated eyes were used.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- A volume of 0.1 mL of the test item, which was found to weigh approximately 91 mg
- Duration of treatment / exposure:
- After 10 seconds the test item was washed off the cornea using a minimum of 20 mL of saline solution (approximately 32 °C).
Immediately following washing of the corneal surface, the treated eye was returned to the superfusion chamber and the saline drip repositioned to irrigate the eye. - Number of animals or in vitro replicates:
- 3
- Details on study design:
- Assessment of corneal cloudiness was made pre-enucleation, post equilibration and approximately 60, 120, 180 and 240 minutes following treatment.
Measurements for corneal thickness were carried out pre-enucleation, post equilibration and approximately 60, 120, 180 and 240 minutes following treatment.
The condition of the corneal epithelium was assessed approximately 60, 120, 180 and 240 minutes following treatment.
The uptake of fluorescein by the corneal epithelium was assessed pre-enucleation, post equilibration and approximately 240 minutes following treatment
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1A
- Value:
- 0
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 3A
- Value:
- 0
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 5A
- Value:
- 0
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 1A
- Value:
- 0
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 3A
- Value:
- 0
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 5A
- Value:
- 0
- Irritation parameter:
- percent corneal swelling
- Remarks:
- % Mean corneal swelling 1 hour following treatment
- Run / experiment:
- mean of 3 test eyes
- Value:
- 12.2
- Irritation parameter:
- percent corneal swelling
- Remarks:
- % Mean corneal swelling 2 hour following treatment
- Run / experiment:
- Mean of 3 test eyes
- Value:
- 11.4
- Irritation parameter:
- percent corneal swelling
- Remarks:
- Mean corneal swelling 4 hours following treatment
- Run / experiment:
- mean of 3 test eyes
- Value:
- 6.6
- Irritation parameter:
- percent corneal swelling
- Remarks:
- 60 min
- Run / experiment:
- mean of 2 control eyes
- Value:
- 7.2
- Irritation parameter:
- percent corneal swelling
- Remarks:
- 120 min
- Run / experiment:
- mean of 2 control eyes
- Value:
- 7.4
- Irritation parameter:
- percent corneal swelling
- Remarks:
- 240 min
- Run / experiment:
- mean of 2 control eyes
- Value:
- 5.3
- Irritation parameter:
- morphological effects
- Remarks:
- Condition of Corneal Epithelium
- Run / experiment:
- 3 runs
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following assessment of the data for all endpoints the test item was considered unlikely to have the potential to cause severe ocular irritancy in vivo.
- Executive summary:
A study was performed to assess the ocular irritancy potential of the test item in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test item in man.
0.1 mL of the test item, which was found to weigh approximately 91 mg, was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32 ±1.5 °C within the superfusion chamber. A further two enucleated eyes remained untreated for control purposes.
Maximal ocular irritation observations recorded for the test eyes were as follows: Corneal Opacity (score 0), Fluorescein Uptake (score 0), Corneal Swelling (60 mins 12.2% test eyes mean of 3 runs vs 7.2% control eyes mean of 2 runs, 120 mins 11.4% test eyes mean of 3 runs vs 7.4% control eyes mean of 2 runs, 240 min 6.6% test eyes mean of 3 runs vs 5.3% control eyes mean of 2 runs), condition of corneal Epithelium (normal).
Following assessment of the data for all endpoints the test item was considered unlikely to have the potential to cause severe ocular irritancy in vivo.
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