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Diss Factsheets
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Reaction mass of sodium amino-bis{[4-(ethenylsubstituted)phenyl]diazenyl}-hydroxynaphthalenesulfonate and polysodium amino-{[4-(ethenylsubstituted)phenyl]diazenyl}-{[4-(ethenylsubstituted)-2-sulfonatophenyl]diazenyl}-hydroxynaphthalenesulfonate and polysodium amino-bis{[4-(ethenylsubstituted)-2-sulfonatophenyl]diazenyl}-hydroxynaphthalenesulfonate
EC number: - | CAS number: -
- 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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- None
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Reconstituted human epidermis
- Source strain:
- not specified
- Vehicle:
- other: Dulbecco’s phosphate buffered saline (DPBS)
- Details on test system:
- EPISKIN Kit
- Duration of treatment / exposure:
- 15 minutes
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 68.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Basis: Assessment of Irritation Potential was based on the % Formazan production. Assessment was as follows: ≤ 50% of negative control- Irritant. > 50% of negative control - Non-irritant. Reversibility: other:. Remarks: The % viability of the test item was 68.1% and it was greater than 50% of the negative control. Hence under the conditions of the study the test item was found to be non-irritant to skin.
In vivo
- Other effects:
- The negative controls mean OD was found to be 1.377, which is well within the acceptability range. The % viability of the positive control was 17.8% and it was lesser than 50% of the negative control, which reflects the irritant nature of positive control and the sensitivity of the tissues used in the study.
Any other information on results incl. tables
RESULTS
BLANK CORRECTED OPTICAL DENSITY (OD) VALUES FOR EACH TISSUE
Blank Corrected ODs |
|||
Replicate |
NC |
PC |
Test item |
Rep 1 |
NCR1a |
PCR1a |
4819R1a |
1.351 |
0.294 |
0.985 |
|
NCR1b |
PCR1b |
4819R1b |
|
1.290 |
0.226 |
0.842 |
|
Rep 2 |
NCR2a |
PCR2a |
4819R2a |
1.505 |
0.232 |
0.946 |
|
NCR2b |
PCR2b |
4819R2b |
|
1.439 |
0.257 |
1.112 |
|
Rep 3 |
NCR3a |
PCR3a |
4819R3a |
1.336 |
0.242 |
0.848 |
|
NCR3b |
PCR3b |
4819R3b |
|
1.341 |
0.226 |
0.898 |
Mean OD of blank: 0.070
MEAN OPTICAL DENSITY (OD) VALUES FOR EACH TISSUE
Mean ODs |
|||
Replicate |
NC |
PC |
Test item |
Rep 1 |
1.320 |
0.260 |
0.913 |
Rep 2 |
1.472 |
0.244 |
1.029 |
Rep 3 |
1.338 |
0.234 |
0.873 |
Mean |
1.377 |
0.246 |
0.938 |
SD |
0.083 |
0.013 |
0.081 |
%RSD |
6.01 |
5.32 |
8.63 |
Key: Rep/R: Replicate; NC: Negative control; PC: Positive control; SD: Standard deviation; %RSD: Percent relative standard deviation; 4819= study number for test item FAT 40865/A TE
PERCENT VIABILITY (%)
% Viability |
||
Replicate |
PC |
Test item |
Rep 1 |
18.852 |
66.328 |
Rep 2 |
17.726 |
74.718 |
Rep 3 |
16.963 |
63.385 |
Mean |
17.847 |
68.144 |
SD |
0.950 |
5.881 |
% RSD |
5.32 |
8.63 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be a non-irritant to skin.
- Executive summary:
An in vitro study was performed in accordance to OECD Guideline 439 in compilance with GLP to assess the skin irritation potential of test item FAT 40865/A . The percent viability of the test item was 68.1% and it was greater than 50% of the negative control. Hence under the conditions of the study the test item was found to be a non-irritant to skin in accordance with UN GHS.
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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