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EC number: 940-123-5 | CAS number: 866889-74-9
- 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 vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2012-09-04 to 2012-09-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 24 August 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 22 July 2010
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 7651-02-7 (Stearic acid 3-(dimethylaminopropyl)amide)
- IUPAC Name:
- 7651-02-7 (Stearic acid 3-(dimethylaminopropyl)amide)
- Details on test material:
- - Chemical name: Stearic acid 3-(dimethylaminopropyl)amide
Constituent 1
Test animals
- Species:
- other: EPISKIN model
Test system
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable, in vitro test
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10.6 to 14.5 mg
- The skin was moistened with 5 μl Milli-Q water (Millipore Corp., Bedford, Mass., USA) to ensure close contact of the test substance to the tissue and the solid test substance
VEHICLE
- no - Duration of treatment / exposure:
- 15
- Observation period:
- 42 h
- Number of animals:
- not applicable, in vitro test
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 108
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean of triplicates. Time point: 15 min exposure, 42 h post exposure . Remarks: test substance. (migrated information)
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean of triplicates. Time point: 15 min exposure, 42 h post exposure . Remarks: negative control (PBS). (migrated information)
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 5
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean of triplicates. Time point: 15 min exposure, 42 h post exposure . Remarks: postitive control (5% SDS). (migrated information)
In vivo
- Irritant / corrosive response data:
- The relative mean tissue viability obtained after 15 minutes treatment with the test substance compared to the negative control tissues was 108%. Since the mean relative tissue viability was above 50%, the test substance is considered to be non-irritant. The positive control had a mean cell viability of 5% after 15 minutes exposure.
Any other information on results incl. tables
Mean absorption in thein vitroskin irritation test with the test substance
|
A |
B |
C |
Mean |
|
SD |
Negative control |
1.122 |
1.012 |
1.083 |
1.073 |
± |
0.056 |
test substance |
1.153 |
1.112 |
1.195 |
1.153 |
± |
0.042 |
Positive control |
0.056 |
0.051 |
0.059 |
0.056 |
± |
0.004 |
OD = opticaldensity
SD = Standard deviation
Triplicate exposures are indicated by A, B and C.
In this table the values are corrected for background absorption (0.000). Isopropanol was used to measure the background absorption.
Mean tissue viability in the in vitro skin irritation test with the test substance
|
|
Negative control |
100 |
test substance |
108 |
Positive control |
5 |
INDIVIDUAL OD MEASUREMENTS AT 570 NM
A |
A |
B (OD570) |
C (OD570) |
Negative control OD570measurement 1 OD570measurement 2 |
1.034 1.211 |
0.995 1.030 |
1.094 1.073 |
test substance on viable tissue OD570measurement 1 OD570measurement 2 |
1.177 1.130 |
1.191 1.033 |
1.199 1.191 |
test substance on killed tissue OD570measurement 1 OD570measurement 2 |
0.055 0.111 |
0.031 0.045 |
0.042 0.065 |
Non treated killed tissue OD570measurement 1 OD570measurement 2 |
0.068 0.085 |
0.073 0.050 |
0.039 0.037 |
Positive control OD570measurement 1 OD570measurement 2 |
0.055 0.057 |
0.050 0.053 |
0.059 0.060 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- In this in vitro skin irritation test Stearic acid 3-(dimethylaminopropyl)amide was not irritating.
- Executive summary:
In an in vitro dermal irritation study according to OECD guideline 439, adopted 22 July 2010 and EU method B.46, August 2009, Stearic acid 3-(dimethylaminopropyl)amide was applied to in triplicate to EPISKIN tissues for 15 min. PBS was used as negative control, 5% SDS as positive control. After exposure the skin tissues were thoroughly rinsed to remove the test substance and transferred to fresh medium. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed.
The relative mean tissue viability obtained after 15 minutes treatment with the test substance compared to the negative control tissues was 108%. Since the mean relative tissue viability was above 50%, the test substance is considered to be non-irritant. The positive control had a mean cell viability of 5% after 15 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 6%, indicating that the test system functioned properly.
In this in vitro skin irritation test Stearic acid 3-(dimethylaminopropyl)amide was not irritating.
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