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EC number: 441-570-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20-25 September 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in a GLP compliant laboratory according to accepted regulatory guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- S-900
- IUPAC Name:
- S-900
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- Nature of substance: Paste
- Name of test material (as cited in study report): S-900
- Physical state: dark brown paste
- Lot/batch No.: 02869
- Storage condition of test material:room temperature In the dark
- Other:
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: reputable commercial supplier
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.54-2.84kg
- Housing: The animals were individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23C
- Humidity (%): 30-70%
- Air changes (per hr): ca 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h light: 12h dark
IN-LIFE DATES: From: To: 20-25 September 1999
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- .1 ML
- Duration of treatment / exposure:
- 72h
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed
- Time after start of exposure:
SCORING SYSTEM: according to the numerical evaluation given in Appendix I, (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 pA8 to 49).
TOOL USED TO ASSESS SCORE: ophthalmascope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 1 day
- Other effects:
- A single instillation of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. Alopecia (loss of fur around the treated eye) was noted in all animals. No ocular effects were noted at the 24-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The test material, S-900, produced a maximum group mean score of 4.7 and was classified as a MINIMAL IRRITANT (CLASS 3 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not produce positive criteria in any rabbit according to the EU labelling regulations.
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