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EC number: 260-694-8 | CAS number: 57357-85-4
- 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:
- weight of evidence
- Study period:
- 2016-02-25 to 2016-09-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 2015-06-28
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [1S-(1α,2β,3α,5α)]-[2,6,6-trimethylbicyclo[3.1.1]hept-3-yl]methylamine
- EC Number:
- 260-694-8
- EC Name:
- [1S-(1α,2β,3α,5α)]-[2,6,6-trimethylbicyclo[3.1.1]hept-3-yl]methylamine
- Cas Number:
- 57357-85-4
- Molecular formula:
- C11H21N
- IUPAC Name:
- 1-[(1S,2S,3S,5R)-2,6,6-trimethylbicyclo[3.1.1]heptan-3-yl]methanamine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: WE 20PA15
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS:
- Liquid / colorless, clear
- pH ~7, undiluted test substance
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Source strain:
- other: 00267
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm EPI-200, MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Tissue lot number: 23317
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 min exposure at room temperature, 1 h exposure at 37 °C.
- Temperature of post-treatment incubation: 3 h at 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing steps: at least one washing step with PBS.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS
- Viability: 1.567 ± 0.068 (MTT QC assay, 4 h, n = 3; acceptance criteria: OD(540 - 570 nm) [1.0 - 3.0])
- Barrier function: 6.7 h (ET-50 assay, 100 µL 1 % tritinX-100, 4 time points, n = 3, MTT Assay; acceptance criteria: ET-50 [4.77 -8.72 h])
- Contamination: No
NUMBER OF REPLICATE TISSUES:
2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed EPI-200 tissues
- Procedure used to prepare the killed tissues: killed by freezing at -20 °C
- No. of replicates : 2
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50 %. In addition, those materials with a viability of > 50 % after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15 %. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 µL
NEGATIVE CONTROL
- Amount applied: 50 µL
POSITIVE CONTROL
- Amount applied: 50 µL - Duration of treatment / exposure:
- 3 min, 1 h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h
- Value:
- 13.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct-MTT reduction: yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Any other information on results incl. tables
Table 1: Exposure period 3 min: Individual and mean OD570 values, individual and mean viability values, standard deviations and coefficient of variation.
|
|
|
|
|
|
|
|
Test substance identification |
|
|
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV [%] |
NC |
Viable tissues |
Mean OD570 |
1.550 |
1.836 |
1.693 |
|
|
|
Viability [% of NC] |
91.6 |
108.4 |
100 |
11.9 |
11.9 |
|
KC tissues |
Mean OD570 |
0.115 |
|
|
0.115 |
|
|
|
Viability [% of NC] |
6.8 |
|
|
6.8 |
|
|
Test substance |
Viable tissues |
Mean OD570 |
0.607 |
0.771 |
0.689 |
|
|
|
Viability [% of NC] |
35.9 |
45.5 |
40.7 |
6.8 |
16.8 |
|
KC tissues |
Mean OD570 |
0.695 |
0.054 |
0.695 |
|
|
|
|
Viability [% of NC] |
41.0 |
3.2 |
41.0 |
|
|
|
Final mean viability of tissues after KC correction [% of NC]***: |
0.0 |
|
|
||||
PC |
Viable tissues |
Mean OD570 |
0.330 |
0.332 |
0.331 |
|
|
|
|
Viability [% of NC] |
19.5 |
19.6 |
19.5 |
0.1 |
0.5 |
* due to organizational reasons, only 1 KC-tissue was used for the NC
** the value of KC-tissue 2 is attributed to be an outlier, therefore it was not used for calculation
*** negative value is set to zero
Table 2: Exposure period 1 h: Individual and mean OD570 values, individual and mean viability values,
standard deviations and coefficient of variation
Test substance identification |
|
|
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV [%] |
NC |
Viable tissues |
Mean OD570 |
1.701 |
1.716 |
1.708 |
|
|
|
Viability [% of NC] |
99.6 |
100.4 |
100.0 |
0.6 |
0.6 |
|
KC tissues |
Mean OD570 |
0.090 |
0.107 |
0.098 |
|
|
|
|
Viability [% of NC] |
5.3 |
6.2 |
5.8 |
0.7 |
11.9 |
|
Test substance |
Viable tissues |
Mean OD570 |
0.777 |
1.017 |
0.897 |
|
|
|
Viability [% of NC] |
45.5 |
59.5 |
52.5 |
9.9 |
18.9 |
|
KC tissues |
Mean OD570 |
0.628 |
0.718 |
0.673 |
|
|
|
|
Viability [% of NC] |
36.8 |
42.0 |
39.4 |
3.7 |
9.4 |
|
Final mean viability of tissues after KC correction [% of NC]***: |
|
|
|
||||
PC |
Viable tissues |
Mean OD570 |
0.096 |
0.085 |
0.090 |
|
|
|
|
Viability [% of NC] |
5.6 |
4.9 |
5.3 |
0.5 |
8.6 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
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.
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