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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
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:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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
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:
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.