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EC number: 248-983-7 | CAS number: 28348-53-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium cumenesulphonate
- EC Number:
- 248-983-7
- EC Name:
- Sodium cumenesulphonate
- Cas Number:
- 28348-53-0
- Molecular formula:
- C9H12O3S.Na
- IUPAC Name:
- sodium cumenesulphonate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Test Substance
CAS Number: 28348-53-0
Identity: Cumene sulfonic acid, sodium salt
Purity: 96.0%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.0 - 2.4 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GembH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye
- Amount / concentration applied:
- Application of 50 mg into the conjunctival sac of one eye.
- Duration of treatment / exposure:
- The test substance was not washed out of the eyes of the treated animals and remained until the test was terminated.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, and 6, 8 and 14 days after application
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Test substance was not washed out
SCORING SYSTEM: according to guideline
TOOL USED TO ASSESS SCORE: ophthalmic lamp, the disappearance of corneal findings was checked by adding Sodium-Fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.94
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Slight irritation at 60% solution.Eye irritation is slight .
Any other information on results incl. tables
Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
1/1/1/1/1/1 |
0/0/0/0/0/0 |
1/1/1/1/1/1 |
1/1/1/3/1/2 |
24 h |
1/1/1/1/1/1 |
1/1/1/1/1/1 |
2/1/1/1/2/1 |
1/1/0/2/1/0 |
48 h |
1/1/1/1/1/1 |
0/1/0/1/0/0 |
1/1/1/1/1/1 |
0/0/0/1/0/0 |
72 h |
1/1/1/1/1/1 |
0/0/0/0/0/0 |
0/1/0/1/1/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
1.00 |
0.44 |
0.94 |
0.33 |
Reversibility*) |
c. |
c. |
c. |
c. |
Average time (unit) for reversion |
14 days |
72 hours |
6 days |
72 hours |
*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible
Animals #1 -3: male; #4 -6: femaApplicant's summary and conclusion
- Interpretation of results:
- other: Slight irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Slight irritation at 60% solution.Eye irritation is slight .
Result: Slight irritating at 60% solution - Executive summary:
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