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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
Skin irritation / corrosion
Administrative data
- 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
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: 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
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
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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.
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