Registration Dossier
Registration Dossier
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EC number: 239-854-6 | CAS number: 15763-76-5
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium p-cumenesulphonate
- EC Number:
- 239-854-6
- EC Name:
- Sodium p-cumenesulphonate
- Cas Number:
- 15763-76-5
- Molecular formula:
- C9H12O3S.Na
- IUPAC Name:
- sodium 4-isopropylbenzenesulfonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kuiper RAbbitry, Gary, Indiana- Age at study initiation: 8-10 weeks- Weight at study initiation: 2.59-2.66 kg- Housing: individually in steel cages- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum):ad libitum- Acclimation period: conditioned for at least 5 days prior to study. Animals were maintained according to "Guide for the Carre and Use of Laboratory Animals", National Academy Press, 1996. ENVIRONMENTAL CONDITIONS- Temperature (°C): 16 - 22- Humidity (%): 30-70- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): "light controlled room"IN-LIFE DATES: From: August 7, 2007 To: August 14, 2007
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: unexposed eye of each animal served as its own control
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit):0.1 gram- Concentration (if solution): undiluted is 40% active ingredientVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle
- Duration of treatment / exposure:
- single dose (no washing)
- Observation period (in vivo):
- at 1, 24, 48 and 72 hours and at 7 days
- Number of animals or in vitro replicates:
- 3 (males)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): no washingSCORING SYSTEM: DraizeTOOL USED TO ASSESS SCORE: fluorescein (2%) and ultraviolet light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The maximum irritation (noted as "moderate") occurred at 24 hours, with effects observed in the cornea, iris and conjunctiva of all three animals. The scores were noticeably lower at 48 hours and again at 72 hours. No irritation was detected at 7 days.
- Other effects:
- Final body weights were within expected range.
Any other information on results incl. tables
See attached tables
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Irritant
- Executive summary:
The eye irritation of Sodium p-cumenesulphonate was assessed following official guideline OECD 405, Acute Eye Irritation/Corrosion.
The maximum irritation occurred at 24 hours, with effects observed in the cornea, iris and conjunctiva of all three animals. The scores were noticeably lower at 48 hours and again at 72 hours. No irritation was detected at 7 days.
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