Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 946-565-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
- Skin irritation: based on the results of 2 distinct in vivo studies in rabbits (using aqueous solutions with a concentration of 15% or 49% solid content, respectively), the registered substance is not irritating to the skin.
- Eye irritation: based on the results of 2 distinct in vivo studies in rabbits (using aqueous solutions with a concentration of 15% or 49% solid content, respectively), the registered substance is not irritating to the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin 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 Skin Irritation testing
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA/CPSC Design, 16 CFR 1500 for Skin Irritation testing
- Principles of method if other than guideline:
- Occlusive 24h application of 0.5 mL of test item to unabraded and abraded skin sites of each rabbit and skin examination at 24 and 72h after application
- GLP compliance:
- yes
- 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 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL per site to unabraded and abraded skin sites
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- Skin reactions graded at 24 and 72 hours after application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: approximately 1'' square
- % coverage: 100 (2-layer gauze patch secured with non-irritation porous adhesive tape)
- Type of wrap if used: entire site covered wth 4 mil plastic wrap and secured with more adhesive tape
REMOVAL OF TEST SUBSTANCE
- At the end of the 24-hour contact period, excess material was removed from the sites
OBSERVATION TIME POINTS
- 24 and 72 hours after application
SCORING SYSTEM:
- Method of calculation: Draize Scoring System - Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24/72h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See details in Table below
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not a skin irritant based on in vivo testing
- Executive summary:
Disodium caprylo amphodiacetate, as Mackam 2CY-75, 15% solids, was tested for its skin irritation potential in New-Zealand White rabbits. The test article was applied as such at a dose of 0.5 mL to unabraded and abraded skin sites on a clipped area of each of 6 rabbits. The test sites were occluded and the test material remained on the skin for a 24-hour contact period. The application sites were graded for indications of skin reactions (erythema and/or edema) using the Draize Scoring System at 24 and 72 hours after sample application.
No significant skin reactions occurred over the observation period.
Under the conditions of the experiment, the primary dermal irritation score was 1.0, indicating that disodium caprylo amphoacetate, as Mackam 2CY-75, 15% solids, is not irritating to the skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Only two-page summary report available
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Determine the degree of skin irritation by the test material when applied to the clipped intact and abraded skin of rabbits
- GLP compliance:
- no
- Specific details on test material used for the study:
- Trade name: Miranol J2M Conc
Purity: not specified
Typical solid content (active + impurities) for the commercial product: 49%
Chemical active ingredient: Disodium caprylo amphoacetate
CAS No.: 68608-64-0
Batch No.: 4349D78 - Species:
- rabbit
- Strain:
- other: albino (strain not specified)
- Details on test animals or test system and environmental conditions:
- No details provided
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL per site to unabraded and abraded skin sites
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- Skin reactions graded at 24 and 72 hours after application
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 10% of total body area
- % coverage: patch area was covered with Webril patches
- Type of wrap if used: entire experimental area sealed with Blenderm Surgical Tape
REMOVAL OF TEST SUBSTANCE
Not specified
OBSERVATION TIME POINTS
- 24 and 72 hours after application
SCORING SYSTEM:
- Method of calculation: Draize Scoring System - Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: Unabraded skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24/72h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See details in Table below
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not a skin irritant based on in vivo testing
- Executive summary:
Disodium caprylo amphodiacetate, as Miranol J2M Conc, was tested for its skin irritation potential in albino rabbits. The test article was applied as such at a dose of 0.5 mL to unabraded and abraded skin sites on a clipped area of each of 3 rabbits. The test sites were occluded and the test material remained on the skin for a 24-hour contact period. The application sites were graded for indications of skin reactions (erythema and/or edema) using the Draize Scoring System at 24 and 72 hours after sample application.
No significant skin reactions occurred over the observation period.
Under the conditions of the experiment, the primary dermal irritation score was 2.0, indicating that disodium caprylo amphoacetate, as Miranol J2M Conc, is not irritating to the skin.
Referenceopen allclose all
Rabbit |
Erythema/Eschar |
Edema |
Erythema/Eschar |
Edema |
Reversibility |
||||||||||||
24h |
48h |
72h |
Mean |
24h |
48h |
72h |
Mean |
24h |
48h |
72h |
Mean |
24h |
48h |
72h |
Mean |
||
512 |
1 |
N/A |
1 |
1.0 |
2 |
N/A |
0 |
1.0 |
1 |
N/A |
1 |
1.0 |
2 |
N/A |
0 | 1.0 | N/A |
513 | 1 | N/A | 0 | 0.5 | 0 | N/A | 0 | 0.0 | 1 | N/A | 0 | 0.5 | 0 | N/A | 0 | 0.0 | N/A |
514 | 1 | N/A | 0 | 0.5 | 1 | N/A | 0 | 0.5 | 1 | N/A | 1 | 1.0 | 1 | N/A | 0 | 0.5 | N/A |
515 | 0 | N/A | 0 | 0.0 | 0 | N/A | 0 | 0.0 | 1 | N/A | 0 | 0.5 | 0 | N/A | 0 | 0.0 | N/A |
516 | 1 | N/A | 0 | 0.5 | 1 | N/A | 0 | 0.5 | 1 | N/A | 1 | 1.0 | 1 | N/A | 0 | 0.5 | N/A |
517 | 1 | N/A | 0 | 0.5 | 0 | N/A | 0 | 0.0 | 1 | N/A | 0 | 0.5 | 1 | N/A | 0 | 0.5 | N/A |
N/A Not assessed |
Erythema/Eschar |
Edema |
Erythema/Eschar |
Edema |
Reversibility |
|||||||||||||
24h |
48h |
72h |
Mean |
24h |
48h |
72h |
Mean |
24h |
48h |
72h |
Mean |
24h |
48h |
72h |
Mean |
||
1 | N/A | 0 | 0.5 | 0 | N/A | 0 | 0.0 | 1 | N/A | 0 | 0.5 | 0 | N/A | 0 | 0.0 | N/A | |
N/A Not assessed |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- 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 - 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 - 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 - 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
- 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.
- 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:
- Only short summary report available
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Instillation of 0.1 mL of test item in one eye of each rabbit and eye examination on days 1, 2, 3, 4 and 7 after instillation
- GLP compliance:
- no
- Specific details on test material used for the study:
- Trade name: Miranol J2M Conc
Purity: not specified
Typical solid content (active + impurities) for the commercial product: 49%
Chemical active ingredient: Disodium caprylo amphoacetate
CAS No.: 68608-64-0
Batch No.: 4349D78 - Species:
- rabbit
- Strain:
- other: albino (strain not specified)
- Details on test animals or tissues and environmental conditions:
- No details provided
- 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): 49% solid content (typical for this commercial product) - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 7 days
- Duration of post- treatment incubation (in vitro):
- Not applicable
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize Scoring System
TOOL USED TO ASSESS SCORE: visual examination - Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- 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:
- >= 1 - <= 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0.7 - <= 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Conjunctival redness and chemosis 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 Miranol J2M Conc, was tested for its eye irritation potential in New-Zealand White rabbits. The test article was instillated as such at a dose of 0.1 mL in one eye of each of 3 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 on Days 1, 2, 3, 4 and 7 after sample instillation.
No significant ocular reactions occurred over the observation period, except slight conjunctival redness in all 3 rabbits with full reversibility within 7 days, and slight conjunctival chemosis in all 3 rabbits with full reversibility within 72h.
Under the conditions of the experiment, disodium caprylo amphoacetate, as Miranol J2M Conc, was not irritating to the eyes.
Referenceopen allclose all
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 |
Rabbit | Cornea | Iris | Conjunctival redness | Conjunctival chemosis | Reversibility | ||||||||||||||||||||
Day 1 | Day 2 | Day 3 | Day 4 | Day 7 | Mean Days 1 -3 | Day 1 | Day 2 | Day 3 | Day 4 | Day 7 | Mean Days 1 -3 | Day 1 | Day 2 | Day 3 | Day 4 | Day 7 | Mean Days 1 -3 | Day 1 | Day 2 | Day 3 | Day 4 | Day 7 | Mean Days 1 -3 | ||
1 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 1 | 1 | 1 | 1 | 0 | 1.0 | 1 | 1 | 0 | 0 | 0 | 0.7 | Yes |
2 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 2 | 2 | 1 | 1 | 0 | 1.7 | 3 | 2 | 0 | 0 | 0 | 1.7 | Yes |
3 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 2 | 1 | 1 | 1 | 0 | 1.3 | 2 | 1 | 0 | 0 | 0 | 1.0 | Yes |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the experimental results and the 2017 CESIO recommendations for CAS 68608-64-0, no classification according to CLP or UN-GHS criteria is warranted for skin or eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.