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EC number: 946-565-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Study in accordance with US FHSA/CPSC design, 16 CFR 1500 for Eye Irritation testing
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:
- other: US FHSA/CPSC design, 16 CFR 1500 for Eye Irritation testing
- Principles of method if other than guideline:
- Instillation of 0.1 mL of test item in one eye of each rabbit and eye examination at 24, 48 and 72h after instillation
- GLP compliance:
- yes
Test material
- Reference substance name:
- Acetic acid, chloro-, reaction products with 2-heptyl-4,5-dihydro-1H-imidazole-1-ethanol and sodium hydroxide
- EC Number:
- 271-792-5
- EC Name:
- Acetic acid, chloro-, reaction products with 2-heptyl-4,5-dihydro-1H-imidazole-1-ethanol and sodium hydroxide
- Cas Number:
- 68608-64-0
- Test material form:
- solid - liquid: aqueous solution
- Details on test material:
- Substance tested as different commercial products:
- Mackam 2CY-75, 15% solids (active + impurities) [batch L-48049] in Acute Oral Toxicity, Skin Irritation and Eye Irritation
- Miranol J2M Conc, 49% solids (typical) [batch 2902D77] in Acute Oral Toxicity, or [batch 4349D78] in Skin Irritation and Eye Irritation
- Miranol J2M Anhydrous Acid, 100% solids (assumed) [batch 5958D80] in Acute Oral Toxicity
- Miranol J2M Freeze Dried, 100% solids (measured) [batch R-0469-203-19] in Genetic Toxicity In Vitro
Constituent 1
- Specific details on test material used for the study:
- Trade name: Mackam 2CY-75
Purity: 15% solids (active and impurities)
Chemical active ingredient: Disodium caprylo amphoacetate
CAS No.: 68608-64-0
Batch No.: L-48049
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 to 10 weeks
- Weight at study initiation: not specified
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature, humidity and light controlled rooms (no details provided)
IN-LIFE DATES: Not detailed
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye served as untreated control for each rabbit
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 15% solid content - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 72 hours
- Duration of post- treatment incubation (in vitro):
- Not applicable
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize Scoring System
TOOL USED TO ASSESS SCORE: visual examination
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
| Rabbit | Cornea | Iris | Conjunctival redness | Conjunctival chemosis | Reversibility | ||||||||||||
| 24h | 48h | 72h | Mean | 24h | 48h | 72h | Mean | 24h | 48h | 72h | Mean | 24h | 48h | 72h | Mean | ||
| 548 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | N/A |
| 549 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | N/A |
| 550 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | 1 | 0 | 0 | 0.3 | 0 | 0 | 0 | 0.0 | Yes |
| 551 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | 1 | 0 | 0 | 0.3 | 0 | 0 | 0 | 0.0 | Yes |
| 552 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | N/A |
| 553 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0.0 | 1 | 0 | 0 | 0.3 | 0 | 0 | 0 | 0.0 | Yes |
| N/A Not applicable | |||||||||||||||||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Conjunctival redness individual mean scores remained below 2 (GHS threshold for classification)
- Conclusions:
- Not an eye irritant based on in vivo testing
- Executive summary:
Disodium caprylo amphodiacetate, as Mackam 2CY-75, 15% solids, was tested for its eye irritation potential in New-Zealand White rabbits. The test article was insitllated as such at a dose of 0.1 mL in one eye of each of 6 rabbits, the contralateral eye serving as an untreated control. The treated eyes were graded for indications of irritation (cornea, iris, conjunctival redness and conjunctival chemosis) using the Draize Scoring System at 24, 48 and 72 hours after sample instillation.
No significant ocular reactions occurred over the observation period, except slight conjunctival redness at 24h in 3 out of 6 rabbits with full reversibility.
Under the conditions of the experiment, disodium caprylo amphoacetate, as Mackam 2CY-75, 15% solids, was not irritating to the eyes.
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