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EC number: 284-943-5 | CAS number: 84989-53-7
- 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:
- 2016-11-07 to 2016-12-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 06-Jul-2012
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(N,N-dimethylpropane-1,3-diamine-N)[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]cobalt(1+) chloride
- EC Number:
- 284-943-5
- EC Name:
- Bis(N,N-dimethylpropane-1,3-diamine-N)[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]cobalt(1+) chloride
- Cas Number:
- 84989-53-7
- Molecular formula:
- C42H44CoN12.Cl
- IUPAC Name:
- hydroxylamine
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: human-derived epidermal keratinocytes
- Source strain:
- not specified
- Vehicle:
- other: DPBS
- Remarks:
- to improve the contact between the test item and the epidermis, DPBS was used
- Details on test system:
- - Source: MatTek Corporation (82105 Bratislava, Slovakia)
- The EpiDerm™ tissue: normal, human-derived epidermal keratinocytes which have been cultured to
form a multilayered, highly differentiated model of the human epidermis
- Surface: 0.63 cm2
- Pre-incubation: 60 minutes in the incubator (37 ± 1 °C, 5% CO2). Then transferred to new wells for about 24 ± 2 hours (37 ± 1.5 °C, 5 ± 1%
CO2, 95 ± 5% RH). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg test item + 25 µL DPBS
- Duration of treatment / exposure:
- 60 min.
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Test system
- Details on study design:
- Details of the test procedure used
- EpiDerm™ tissue of human-derived epidermal keratinocytes was used (EPI-200-SIT Kit, Lot No.: 23378 Kit E, 23385)
- Conditions of exposure: 37 ± 1 C°C, 5 % CO2, 95% RH
- Washing: inserts gently rinsed with DPBS at least 15 times
- Number of tissue replicates used per test chemical and controls: 3
- MTT assay: incubation with 1 mL of MTT solution for 60 minutes at 37 ± 1 °C
- Data evaluation: the following was calculated: The mean OD of the three negative control tissues was calculated after blank correction. This value corresponds to 100% tissue viability in the current test. For each individual tissue treated with the test item or the positive control the individual relative tissue viability is calculated according to the following formula:
Relative viability(%) = (mean OD test item / positive control / mean OD negative control) x 100.
For the test item and the positive control the mean relative viability ± rel. standard deviation of the three individual tissues was calculated
- Description of evaluation criteria: The test substance may be considered as non-irritant to skin in accordance with UN GHS “No Category” if the tissue viability after exposure and post-treatment incubation is more than 50%.
- Historical data positive control: Mean Viability: 3.9%; Rel. Standard Deviation: 4.4%; Mean Absorption: 1.831
- Acceptability of the Assay: the results are acceptable if
(1) tissue viability is meeting the acceptance criterion, i.e. if the mean OD570 of the negative control tissues is ≥ 0.8 and ≤ 2.8 (negative control),
(2) the relative tissue viability of the positive control is ≤ 20% (positive control) and
(3) the SD of 3 identical replicates is < 18%.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Single test with three tissues
- Value:
- >= 88.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The acceptance criteria were met
Any other information on results incl. tables
Pre-experiments:
The MTT-reducing capacity was tested. The mixture turned blue/purple.
The non-specific MTT reducing capacity (NSMTT) was assessed. The NSMTT was 8.2 % (≤ 30 %), hence correction is needed.
The non-specific coloring was also assessed. The NSC was found to be 2.1 % (≤ 5 %). Therefore, no correction of the results was necessary.
Main test:
Name |
Negative control |
Positive Control |
Test Material |
||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
absolute OD570 |
2.021 |
1.928 |
1.971 |
0.105 |
0.107 |
0.113 |
1.927 |
1.822 |
2.005 |
2.020 |
1.959 |
2.045 |
0.114 |
0.110 |
0.118 |
1.995 |
1.824 |
2.022 |
|
OD570(blank-corrected) |
1.978 |
1.885 |
1.928 |
0.062 |
0.064 |
0.070 |
1.884 |
1.779 |
1.962 |
1.977 |
1.916 |
2.002 |
0.071 |
0.067 |
0.075 |
1.952 |
1.782 |
1.979 |
|
mean OD570of the duplicates (blank-corrected) |
1.978 |
1.900 |
1.965 |
0.067 |
0.066 |
0.073 |
1.918 |
1.780 |
1.970 |
total mean OD570of 3 replicate tissues (blank-corrected) |
1.948* |
0.068 |
1.890 |
||||||
TODTT |
- |
- |
1.808 |
||||||
SD OD570 |
0.042 |
0.004 |
0.098 |
||||||
relative tissue viability [%] |
101.5 |
97.6 |
100.9 |
3.4 |
3.4 |
3.7 |
98.5 |
91.4 |
101.2 |
mean relative tissue viability [%] |
100.0 |
3.5 |
97.0 |
||||||
NSMTT-corrected mean relative tissue viability [%] |
- |
- |
88.8 |
||||||
SD tissue viability [%] |
2.1 |
0.2 |
5.0 |
||||||
CV [% viabilities] |
2.1 |
5.5 |
5.2 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean tissue viability was 88.8% (NSMTT corrected). Since this is above 50%, it is concluded that the test item shows no irritant effects.
- Executive summary:
The potential of the test item to induce skin irritation was analysed by using the three-dimensional human epidermis model EpiDerm (MatTek) comprising a reconstructed epidermis with a functional stratum corneum. The test was according to OECD 439 guideline and in compliance to GLP.
The test substance was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay. Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS.
The test item showed MTT-reducing capability. Since the substance was classified as “non-irritant” in the main experiment, a correction procedure for determination of NSMTT (non-specific reduction of MTT) was necessary. The true MTT metabolic conversion (TODTT) of the test item treated living tissues TM was therefore corrected to 1.808, NSMTT was calculated to 8.2%.
The test item showed colouring potential after mixture with water and isopropanol. The spectral analysis of the mixture showed relevant absorption in the range of 570 ± 30 nm. Since the substance was classified as “non-irritant” in the main experiment (mean relative tissue viability > 50%), a correction procedure for determination of NSCliving (non-specific colour of additional viable tissues) was necessary. NSClivingwas 2.1 % (≤ 5%) relative to the negative control of living epidermis, therefore no correction of the results and no determination of NSCkilled ( non-specific colour of additional killed tissues) was necessary.
The mean relative tissue viability (% negative control) was 88.8% (NSMTT-corrected) after 60 min treatment and 42 h post-incubation. Since this is > 50% it can be concluded that the test item showed no irritant effects.
The controls confirmed the validity of the study.
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