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EC number: 629-764-9 | CAS number: 164524-02-1
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Please see Category Approach
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Hazelton Research Products, Michigan- Age at study initiation: 4 months- Weight at study initiation: males 2722-2783g; females 2600-2779g- Housing: individually in hanging stainless steel wire mesh cages- Diet: up to 125 g/day - Water: ad libitum- Acclimation period: minimum of 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): controlled - Humidity (%): controlled- Air changes (per hr): controlled- Photoperiod (hrs dark / hrs light): 12/12- other: animals were maintained in accordance with the recommendations contained in the D.H.H.S. Publication "Guide for Care and Use of Laboratory Animals IN-LIFE DATES: From: April 13 To: April 18
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye of animal served as control
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 mL- Concentration (if solution): 31.2% active ingredientVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle used
- Duration of treatment / exposure:
- The test substance was instilled into the cupped conjunctival sac of the right (test) eye and the eyelids were then gently held together for one second before release.
- Observation period (in vivo):
- 72 hours total
- Number of animals or in vitro replicates:
- 4 male and 4 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): not doneSCORING SYSTEM: Draize methodTOOL USED TO ASSESS SCORE: fluoresceinLeft eye of each test animal served as control. Manipulated in an identical manner as right (test) eye except no test substance administered
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- >= 0 - <= 18.6
- Max. score:
- 18.6
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- hour 1 = 18.6; hour 24 = 6.2; hour 48 = 0.8; hour 72 = 0.0
- Other effects:
- The score for redness of the conjunctivae ranged from 3-2 at 1 hour but cleard by 48 hour in 3 animals and by 72 hour in all animals.The score for chemosis of the lids and /or nictitating membranes ranged from 3-2 at 1 hour but cleared by 48 hour in all animals.The score for conjuntival discharge ranged from 2-1 at 1 hour but none noted by 24 hours. Discharge was clear at 1 hour.
- Interpretation of results:
- other: mildly irritating
- Remarks:
- Criteria used for interpretation of results: not specified
- Conclusions:
- The test substance is mildly irritating to the eye
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- potassium 4-isopropylbenzenesulphonate
- EC Number:
- 629-764-9
- Cas Number:
- 164524-02-1
- Molecular formula:
- C9H12O3S.K
- IUPAC Name:
- potassium 4-isopropylbenzenesulphonate
- Reference substance name:
- no EINECS yet
- IUPAC Name:
- no EINECS yet
- Test material form:
- solid: bulk
- Details on test material:
- - Name of test material : K-Cumenesulfonate (dried material)
- Substance type: Product
- Physical state: solid
- Analytical purity:
- Impurities (identity and concentrations):
- Purity test date:
- Lot/batch No.: T7714
- Expiration date of the lot/batch:
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Hazelton Research Products, Michigan- Age at study initiation: 4 months- Weight at study initiation: males 2722-2783g; females 2600-2779g- Housing: individually in hanging stainless steel wire mesh cages- Diet: up to 125 g/day - Water: ad libitum- Acclimation period: minimum of 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): controlled - Humidity (%): controlled- Air changes (per hr): controlled- Photoperiod (hrs dark / hrs light): 12/12- other: animals were maintained in accordance with the recommendations contained in the D.H.H.S. Publication "Guide for Care and Use of Laboratory Animals IN-LIFE DATES: From: April 13 To: April 18
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye of animal served as control
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 mL- Concentration (if solution): 31.2% active ingredientVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle used
- Duration of treatment / exposure:
- The test substance was instilled into the cupped conjunctival sac of the right (test) eye and the eyelids were then gently held together for one second before release.
- Observation period (in vivo):
- 72 hours total
- Number of animals or in vitro replicates:
- 4 male and 4 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): not doneSCORING SYSTEM: Draize methodTOOL USED TO ASSESS SCORE: fluoresceinLeft eye of each test animal served as control. Manipulated in an identical manner as right (test) eye except no test substance administered
Results and discussion
In vivo
Results
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- >= 0 - <= 18.6
- Max. score:
- 18.6
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- hour 1 = 18.6; hour 24 = 6.2; hour 48 = 0.8; hour 72 = 0.0
- Other effects:
- The score for redness of the conjunctivae ranged from 3-2 at 1 hour but cleard by 48 hour in 3 animals and by 72 hour in all animals.The score for chemosis of the lids and /or nictitating membranes ranged from 3-2 at 1 hour but cleared by 48 hour in all animals.The score for conjuntival discharge ranged from 2-1 at 1 hour but none noted by 24 hours. Discharge was clear at 1 hour.
Applicant's summary and conclusion
- Interpretation of results:
- other: mildly irritating
- Remarks:
- Criteria used for interpretation of results: not specified
- Conclusions:
- The test substance is mildly irritating to the eye
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