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EC number: 700-700-2 | CAS number: 1369492-55-6
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 January 2011 to 16 August 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[(3E)-11-(dichloromethylidene)tricyclo[6.2.1.0²,⁷]undec-2(7)-en-3-ylidene]hydroxylamine
- EC Number:
- 700-700-2
- Cas Number:
- 1369492-55-6
- Molecular formula:
- C12H13Cl2NO
- IUPAC Name:
- N-[(3E)-11-(dichloromethylidene)tricyclo[6.2.1.0²,⁷]undec-2(7)-en-3-ylidene]hydroxylamine
- Details on test material:
- - Physical state: solid
- Stability under test conditions: not reported
- Storage condition of test material: At room temperature at about 20 °C
Constituent 1
Test animals
- Species:
- other: EpiDerm tissues (three-dimensional human skin model)
- Details on test animals or test system and environmental conditions:
- No test animals were used.
EpiDerm tissues were supplied by MatTek Corporation, Ashland, Massachusetts, USA and stored refrigerated. Tissues were transferred to 6-well plates with the assay medium 90 minutes before starting the assay.
Test system
- Type of coverage:
- other: Not applicable
- Preparation of test site:
- other: Not applicable
- Vehicle:
- other: Not applicable - no vehicle used
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 40 mg
- Concentration (if solution): Undiluted test material - Duration of treatment / exposure:
- Contact time of 3 minutes or 1 hour
- Observation period:
- Incubated at 37°C for 3 hours
- Number of animals:
- No animals were used on this test.
Four EpiDerm tissues were used per test substance, negative and positive control - Details on study design:
- APPLICATION OF TEST AND CONTROL MATERIALS:
Immediately prior to treatment was intitiated the assay medium was replaced.
Approximately 40 mg of solid test substance was placed onto the tissue and moistened with 25 µL water to ensure good contact with the tissue surface. Further tissues were treated with 40 mL distilled water (negative control) and with 40 mL 8N potassium hydroxide (positive control).
Duplicate tissues were used for each contact time (3 minutes or 1 hour).
After the 3 minute or 1 hour contact periods, the tissues were washed with phosphate buffered saline (PBS) to remove residual material.
CELL VIABILITY MEASUREMENTS:
The assay medium was replaced with 300 mL of 1 mg/mL MTT-medium and tissues were incubated for 3 hours at 37°C. After incubation, the tissues were washed with PBS and formazan was extracted with 2 mL isopropanol overnight, without shaking.
The optical density of the extracted formazan was determined spectrophotometrically at 570 nm and cell viability was calculated for each tissue as a percentage of the mean of the negative control tissue. Skin corrosivity potential of the test article was classified according to the remaining cell viability obtained after test article treatment with either of the two treatment times.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 105
- Remarks on result:
- other: Basis: mean
- Remarks:
- Time point: 3 minutes. Reversibility not measured.
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 101
- Remarks on result:
- other: Basis: mean.
- Remarks:
- Time point: 1 hour. Reversibility not measured.
Any other information on results incl. tables
Skin corrosion assay; cell viability measurements
3 minute treatment
Substance |
Tissue replicate |
OD540 |
Mean |
Tissue mean |
% difference between Rep’s |
% Relative survival |
||
Aliquot 1 |
Aliquot 2 |
Aliquot 3 |
||||||
Negative control |
A |
1.521 |
1.527 |
1.527 |
1.525 |
1.617 |
10.8 |
100 |
B |
1.710 |
1.709 |
1.708 |
1.709 |
||||
Test article |
A |
1.662 |
1.777 |
1.793 |
1.744 |
1.702 |
-5.0 |
105 |
B |
1.602 |
1.688 |
1.692 |
1.660 |
||||
Positive control |
A |
0.418 |
0.428 |
0.426 |
0.424 |
0.425 |
-0.4 |
26 |
B |
0.424 |
0.425 |
0.428 |
0.426 |
1 hour treatment
Substance |
Tissue replicate |
OD540 |
Mean |
Tissue mean |
% difference between Rep’s |
% Relative survival |
||
Aliquot 1 |
Aliquot 2 |
Aliquot 3 |
||||||
Negative control |
A |
1.854 |
1.852 |
1.844 |
1.850 |
1.771 |
-9.3 |
100 |
B |
1.711 |
1.684 |
1.683 |
1.693 |
||||
Test article |
A |
1.762 |
1.767 |
1.752 |
1.760 |
1.791 |
3.4 |
101 |
B |
1.823 |
1.841 |
1.804 |
1.823 |
||||
Positive control |
A |
0.224 |
0.238 |
0.228 |
0.230 |
0.239 |
-8.0 |
13 |
B |
0.247 |
0.251 |
0.246 |
0.248 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered not to be corrosive to the invitro skin testing model, EpiDerm.
- Executive summary:
The result indicates that the substance should be non-corrosive to skin. Without furtherin vivodata the result has to be considered as inconclusive regarding classification.
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