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EC number: 690-526-2 | CAS number: 38632-47-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
- Principles of method if other than guideline:
- Three New Zealand White (Hsdlf: NZW) strain rabbits were used for the eye irritation study. 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. The left eye remained untreated and was used for control purposes. I
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 Draize, (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). - GLP compliance:
- yes
Test material
- Reference substance name:
- Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt
- EC Number:
- 690-526-2
- Cas Number:
- 38632-47-2
- Molecular formula:
- C8H14S2N2O8.Na2
- IUPAC Name:
- Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt
- Details on test material:
- Description: white powder
Purity: 84.7%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- For the purpose of the study the test item was used as supplied
- Controls:
- not required
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable - score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Other effects:
- All animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
No corneal or iridial effects were noted during the study.
In the conjunctivae, grade 2 redness and grade 1 chemosis and discharge were noted in all treated eyes one hour after treatment. Grade 1 redness was noted in all treated eyes and grade 1 chemosis was noted in two treated eyes at the 24-hour observation. Grade 1 redness was noted in two treated eyes at the 48-hour observation.
One treated eye appeared normal at the 48-hour observation and two treated eyes appeared normal at the 72-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
Three New Zealand White (Hsdlf: NZW) strain rabbits were used for the eye irritation study. 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. The left eye remained untreated and was used for control purposes. I 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 Draize.
No corneal or iridial effects were noted during the study.
In the conjunctivae, grade 2 redness and grade 1 chemosis and discharge were noted in all treated eyes one hour after treatment. Grade 1 redness was noted in all treated eyes and grade 1 chemosis was noted in two treated eyes at the 24-hour observation. Grade 1 redness was noted in two treated eyes at the 48-hour observation.
One treated eye appeared normal at the 48-hour observation and two treated eyes appeared normal at the 72-hour observation.
As a result, the test item has not to be classified as irritating to the eyes.
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