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EC number: 812-378-1 | CAS number: 210420-85-2
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 July 2017 - 21 July 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Not applicable
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC Guideline No. 440/2008. Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test". Official Journal of the European Union No. L142
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 210420-85-2
- Reference substance name:
- N-methyldidecylamine
- EC Number:
- 230-990-1
- EC Name:
- N-methyldidecylamine
- Cas Number:
- 7396-58-9
- Molecular formula:
- C21H45N
- IUPAC Name:
- N-decyl-N-methyldecan-1-amine
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Reference substance name:
- Adipic acid
- EC Number:
- 204-673-3
- EC Name:
- Adipic acid
- Cas Number:
- 124-04-9
- Molecular formula:
- C6H10O4
- IUPAC Name:
- adipic acid
- Test material form:
- solid
- Details on test material:
- - Appearance: Slightly yellow gel
- Storage conditions: At room temperature; container flushed with nitrogen
Constituent 1
Constituent 2
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- not applicable
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Details on animal used as source of test system:
- not applicable
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model
- Tissue batch number(s): 26490 (kit K and L) and 26708 (kit L and M)
- Surface: 0.6 cm^2
- On the day of receipt the tissues were kept on agarose and stored in the refrigerator.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 minute exposure: room temperature, 1 hour exposure: 36.8 - 37.5°C.
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: the tissues were washed with phosphate buffered saline (one washing step)
- Observable damage in the tissue due to washing: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Amount of MTT medium used: 300 µL
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 4 (2 tissues for the 3 minute exposure period, 2 tissues for the 1 hour exposure period) + 2 tissue for the negative and the positive control for each exposure period
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (see table 1 in ''any other informatin on methods'')
A test item is considered corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%.
b) In addition, a test item considered non-corrosive (viability = 50%) after the 3-minute treatment is considered corrosive if the relative tissue viability after 1-hour treatment with the test item is decreased below 15%.
A test item is considered non corrosive in the in vitro skin corrosion test if:
a) The relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%.
b) In addition, the relative tissue viability after the 1-hour treatment is not decreased below 15%.
ACCEPTABILITY CRITERIA:
a) The absolute mean OD570 of the two tissues of the negative control should reasonably be within the acceptance limits of OECD 431 (lower acceptance limit =0.8 and upper acceptance limit =2.8)
b) The mean relative tissue viability following 1-hour exposure to the positive control should be <15 %.
c) In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates should be = 30%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: an excess amount (undiluted)
NEGATIVE CONTROL
- Amount applied: 50 µL
POSITIVE CONTROL
- Amount applied: 50 µL (8N KOH) - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 4 in total; 2 per exposure period
Test animals
- Details on test animals or test system and environmental conditions:
- not applicable
Test system
- Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Liquid test item applied directly on top of the tissue
- Duration of treatment / exposure:
- 3 minute exposure and 1 hour exposure
- Observation period:
- not applicable
- Number of animals:
- not applicable
- Details on study design:
- not applicable
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean of 2 replicates
- Run / experiment:
- 3-minute exposure period; experiment 1
- Value:
- 53
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 6.7%
- Remarks on result:
- other: CV between replicates: 16%
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean of 2 replicates
- Run / experiment:
- 3-minute exposure period; experiment 2
- Value:
- 39
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 6.3%
- Remarks on result:
- other: CV between replicates: 10%
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean of 2 replicates
- Run / experiment:
- 1-hour exposure period
- Value:
- 36
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 9.6%
- Remarks on result:
- other: CV between replicates: 23%
- Other effects / acceptance of results:
- - The individual viabilities of the tissues treated with test item were spread over 2 categories (48% and 57%) therefore the 3-minute exposure period was repeated. The repeated experiment showed individual tissue viabilities of 37% and 42% and was therefore considered acceptable and used to determine the final conclusion.
- OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, the absolute mean OD570 was between the acceptance limits (i.e., 1.971 for the 3-minute exposure and 1.744 for the 1-hour exposure).
- Acceptance criteria met for positive control: yes, the mean relative tissue viability following 1 hour exposure was <15% (i.e., 9.6%).
- Acceptance criteria met for variability between replicate measurements: yes, CV between tissue replicates was =30% (i.e., 10% for the 3 minute exposure periods and 23% for the 1 hour exposure period).
In vivo
- Irritant / corrosive response data:
- not applicable
- Other effects:
- not applicable
Any other information on results incl. tables
Table 2 Individual OD measurements at 570 nm
|
3-minute application (OD570) A B |
1-hour application (OD570) A B |
||
Negative control OD570measurement 1 OD570measurement 2 OD570measurement 3 |
|
|
||
1.6481 |
1.7265 |
1.7199 |
1.8792 |
|
1.6399 |
1.7571 |
1.6803 |
1.8309 |
|
1.7038 |
1.7773 |
1.7232 |
1.8794 |
|
1-Decanaminium, N-decyl-N,N-dimethyl-, hexanedioate (2:1) OD570measurement 1 OD570measurement 2 OD570measurement 3 |
|
|
||
0.8198 |
0.9787 |
0.5830 |
0.7528 |
|
0.8592 |
1.0003 |
0.5961 |
0.7578 |
|
0.8449 |
1.0043 |
0.6021 |
0.7686 |
|
Positive control OD570measurement 1 OD570measurement 2 OD570measurement 3 |
|
|
||
0.1488 |
0.1510 |
0.2237 |
0.1978 |
|
0.1585 |
0.1482 |
0.2186 |
0.1980 |
|
0.1607 |
0.1536 |
0.2237 |
0.1954 |
Repeat experiment |
3-minute application (OD570) A B |
|
Negative control OD570measurement 1 OD570measurement 2 OD570measurement 3 |
|
|
1.9161 |
2.0235 |
|
2.0228 |
2.0685 |
|
2.0073 |
2.0446 |
|
1-Decanaminium, N-decyl-N,N-dimethyl-, hexanedioate (2:1) OD570measurement 1 OD570measurement 2 OD570measurement 3 |
|
|
0.7352 |
0.8733 |
|
0.7976 |
0.8560 |
|
0.8016 |
0.8579 |
|
Positive control OD570measurement 1 OD570measurement 2 OD570measurement 3 |
|
|
0.1424 |
0.1780 |
|
0.1579 |
0.1833 |
|
0.1567 |
0.1826 |
OD = Optical density; Duplicate exposures are indicated by A and B.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The results of a skin corrosion test, performed according to OECD guideline 431, showed that 1-Decanaminium, N-decyl-N,N-dimethyl-, hexanedioate (2:1) was corrosive to the skin (tissue viability of 39% after 3-minute exposure). The test substance is therefore classified as category 1 according to GHS and according to Regulation (EC) 1272/2008.
- Executive summary:
The results of a skin corrosion test, performed according to OECD guideline 431, showed that 1-Decanaminium, N-decyl-N,N-dimethyl-, hexanedioate (2:1) was corrosive to the skin (tissue viability of 39% after 3-minute exposure). The test substance is therefore classified as category 1 according to GHS and according to Regulation (EC) 1272/2008.
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