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Toxicological information

Eye irritation

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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:
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:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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:

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