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EC number: 287-267-9 | CAS number: 85455-32-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to OECD 439 Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UN GHS (2003, last rev. 2009)
- Deviations:
- no
- Principles of method if other than guideline:
- Based on a “Statement on the Scientific Validity of In Vitro Tests for Skin Irritation” of the European Commission (November 2008), official acceptance of the test method in the EU was achieved and implemented in EU, 2008a, Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to EC Regulation No 1907/2006 of the European Parliament and of the Council on REACH; 1st ATP 2009: EC Regulation No 761/2009 of 23 July 2009 amending, for the purpose of its ATP, EC Regulation No 440/2008 laying down test methods pursuant to EC Regulation No 1907/2006 of the European Parliament and of the Council on REACH, section B46.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrogen hydroxy[2-hydroxy-3-[(2-hydroxy-3-nitrobenzylidene)amino]-5-nitrobenzenesulphonato(3-)]chromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- EC Number:
- 287-267-9
- EC Name:
- Hydrogen hydroxy[2-hydroxy-3-[(2-hydroxy-3-nitrobenzylidene)amino]-5-nitrobenzenesulphonato(3-)]chromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- Cas Number:
- 85455-32-9
- Molecular formula:
- C13H7CrN3O10S.C11H25NO.H
- IUPAC Name:
- Hydrogen hydroxy[2-hydroxy-3-[(2-hydroxy-3-nitrobenzy-lidene)amino]-5-nitrobenzenesulphonato(3-)]chromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- other: reconstituted human epidermis model
Test system
- Type of coverage:
- other: Topical
- Preparation of test site:
- other: Not applicable
- Vehicle:
- other: No vehicle used
- Amount / concentration applied:
- Each approximately 25 mg (~ 39 mg/cm2 according to guideline) of the test item were applied to the tissues, wetted with 25 µL of DPBS, and spread to match the surface of the tissue for a complete treatment time of 60 minutes.
- Duration of treatment / exposure:
- 60 minutes
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- Each three tissues of the human skin model EpiDerm™ were treated with the test item, the negative and the positive control for 60 minutes.
Approximately 25 mg of the test item were applied to each tissue, wetted with 25 µL of DPBS, and spread to match the surface of triplicate tissue.
30 µL of either the negative control (DPBS) or the positive control (5% SLS) were applied to triplicate tissue each.
The test item and the positive and negative controls were washed off the skin tissues after 60 minutes treatment. After further incubation for about 43 hours the tissues were treated with the MTT solution for 3 hours following 69.75 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- expressed as mean relative absorbance
- Run / experiment:
- all 3
- Value:
- > 97.8 - < 105.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Results after treatment with the test item and the controls
Dose Group |
Ex-po-sure Interval |
Tissue No. |
Absorbance 570 nm |
Absorbance 570 nm |
Absorbance 570 nm |
Mean Absorbance of 3 Wells |
Mean-Absorbance of three wells blank corrected |
Mean Absorbance of 3 wells after blank correction* |
Rel. Absorbance [%] Tissue 1, 2 + 3* |
Relative Standard Deviation [%] |
Mean Rel. Absorbance [% of Negative Control]** |
Mean Absorbance Blank corrected viable tissue without MTT (Step 2) |
Mean Rel. Absorbance [% of Negative Control] after colour interference and MTT reduction correction |
Blank |
|
|
0.036 |
0.037 |
0.036 |
0.036 |
0.000 |
|
|
|
|
|
|
Negative Control |
60 min |
Tissue 1 |
1.736 |
1.703 |
1.695 |
1.711 |
1.675 |
1.673 |
100.1 |
1.1 |
100.0 |
|
|
Tissue 2 |
1.679 |
1.688 |
1.699 |
1.689 |
1.653 |
98.8 |
|||||||
Tissue 3 |
1.725 |
1.713 |
1.740 |
1.726 |
1.690 |
101.0 |
|||||||
Positive Control |
60 min |
Tissue 1 |
0.116 |
0.116 |
0.118 |
0.117 |
0.081 |
0.075 |
4.8 |
6.6 |
4.5 |
|
|
Tissue 2 |
0.107 |
0.111 |
0.109 |
0.109 |
0.073 |
4.4 |
|||||||
Tissue 3 |
0.108 |
0.105 |
0.110 |
0.107 |
0.071 |
4.3 |
|||||||
Test Item |
60 min |
Tissue 1 |
1.800 |
1.774 |
1.835 |
1.8037 |
1.767 |
1.711 |
105.7 |
4.0 |
102.3 |
0.009 |
101.8 |
Tissue 2 |
1.677 |
1.685 |
1.654 |
1.672 |
1.636 |
97.8 |
|||||||
Tissue 3 |
1.765 |
1.758 |
1.775 |
1.766 |
1.730 |
103.4 |
* relative absorbance per tissue [rounded values]: 100 x (absorbancetissue) divided by mean absorbance negative control
** relative absorbance per treatment group [rounded values]: 100 x (mean absorbance test item/positive control) divided by (mean absorbance negative control)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to skin according to UN GHS and EU CLP regulation.
- Executive summary:
This in vitro study was performed to assess the irritation potential of the test item by means of the Human Skin Model Test.
The test item passed the MTT interference pre-test. Due to its intensive colour, an additional test with one viable tissue (without MTT addition) was necessary to correct the result in the main experiment.
Approximately 25 mg of the test item were applied to each tissue, wetted with 25 µL of DPBS, and spread to match the surface of triplicate tissue.
30 µL of either the negative control (DPBS) or the positive control (5% SLS) were applied to triplicate tissue each.
The test item and the positive and negative controls were washed off the skin tissues after 60 minutes treatment. After further incubation for about 42 hours the tissues were treated with the MTT solution for 3 hours following 69 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.
After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD³0.8 and ≤ 2.8 for the 60 minutes treatment interval thus showing the quality of the tissues.
Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 4.5% thus ensuring the validity of the test system.
The relative standard deviations between the % variability values of the test item, the positive and negative controls in the main test were below 7% (threshold of the "OECD Guideline for the Testing of Chemicals 439:In vitroSkin Irritation: Reconstructed Human Epidermis Test Method”: < 18%), thus ensuring the validity of the study.
Compared to the relative absorbance value of the negative control the mean relative absorbance value was not reduced (101.8%) after exposure of the skin tissues to the test item. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
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