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Reaction mass of Chromate(1-), [2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)][methyl [7-hydroxy-8-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-1-naphthalenyl]carbamato(2-)]-, sodium and sodium bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-mesylphenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]chromate(1-) and sodium bis[methyl [7-hydroxy-8-[[2-hydroxy-5-mesylphenyl]azo]-1-naphthyl]carbamato(2-)]chromate(1-)
EC number: 915-704-1 | 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
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2016-10-06 to 2017-08-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
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:
- 2015-07-28
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of Chromate(1-), [2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)][methyl [7-hydroxy-8-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-1-naphthalenyl]carbamato(2-)]-, sodium and sodium bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-mesylphenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]chromate(1-) and sodium bis[methyl [7-hydroxy-8-[[2-hydroxy-5-mesylphenyl]azo]-1-naphthyl]carbamato(2-)]chromate(1-)
- EC Number:
- 915-704-1
- Molecular formula:
- C36H28ClCrN7O10S2.Na / C34H26Cl2CrN8O8S2.Na / C38H30CrN6O12S2.Na
- IUPAC Name:
- Reaction mass of Chromate(1-), [2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)][methyl [7-hydroxy-8-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-1-naphthalenyl]carbamato(2-)]-, sodium and sodium bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-mesylphenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]chromate(1-) and sodium bis[methyl [7-hydroxy-8-[[2-hydroxy-5-mesylphenyl]azo]-1-naphthyl]carbamato(2-)]chromate(1-)
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: 001-140902
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS: Solid / brown, pH ca. 6 (undiluted test substance, moistened with de-ionized water; determined in the lab prior to start of the GLP study)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Demanded by the Guideline.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM model, EPI-200, MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Tissue lot number: 23362
- Date of initiation of testing: 2016-10-11
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature, 1 min or 37 °C, 1 h
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The tissues were washed with PBS to remove residual test material 3 minutes or 1 hour after start of the application treatment.
- Observable damage in the tissue due to washing: No
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
- Filter: without reference filter
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
Barrier function and Quality control (QC): The supplier demonstrates that each batch of the model used meets the defined production release criteria. MatTek determines the ET50 value following exposure to Triton X-100 (1 %) for each EpiDermTM batch. The ET50 must fall within a range established based on a historical database of results. The following acceptability range (upper and lower limit) for the ET50 is established by the supplier as described in the cited OECD guidelines. Lower acceptance limit: ET50 = 4.0 hours; Upper acceptance limit: ET50 = 8.7 hours
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues
- Procedure used to prepare the killed tissues: freezing
- No of replicates: 2
- Method of calculation used: see "Any other information on materials and methods"
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50 %, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 25 µL deionized water + 25 µL test substance (bulk volume)
NEGATIVE CONTROL
- Amount applied: 50 µL
POSITIVE CONTROL
- Amount applied: 50 µL
- Concentration: 8 N - Duration of treatment / exposure:
- 3 min or 1 h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 113.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h
- Value:
- 95.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: Mechanical damage of KC tissue No. 2 (1 h incubation) occurred during the washing procedure
- Direct-MTT reduction: Due to the intense color of the test substance, it was not possible to evaluate whether the test substance is able to directly reduce MTT. Therefore, freeze-killed control tissues (KC) were treated with the test article and the negative control in the same way as described above.
- Colour interference with MTT: Due to the color of the test substance, a pretest (experimental conduct in accordance with GLP, but without a GLP status) was performed as follows: the test substance was applied to a KC tissue, incubated for 1 hour and removed by washing. Thereafter, extraction in isopropanol was performed and the OD570 of the extract was spectrophotometrically determined. Based on the result of the pretest, it was judged that application of color control tissues is not necessary.
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 3: Individual and ean OD570 values, individual and mean viability values, standard deviations and coefficient of variation
Exposue Time: 3 min |
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV (%) |
||
NC |
Viable Tissue |
Mean OD570 |
1.971 |
1.899 |
1.935 |
|
|
Viability (% of NC) |
101.8 |
98.2 |
100.0 |
2.6 |
2.6 |
||
KC Tissue |
Mean OD570 |
0.120 |
0.102 |
0.111 |
|
|
|
Viability (% of NC) |
6.2 |
5.3 |
5.7 |
0.7 |
11.4 |
||
Test Substance |
Viable Tissue |
Mean OD570 |
2.141 |
2.273 |
2.207 |
|
|
Viability (% of NC) |
110.6 |
117.5 |
114.0 |
4.8 |
4.2 |
||
KC Tissue * |
Mean OD570 |
0.000 |
0.029 |
0.015 |
|
|
|
Viability (% of NC) |
0.0 |
1.5 |
0.7 |
1.1 |
141.4 |
||
Final mean viability of tissues after KC correction (% of NC) |
113.3 |
|
|
||||
PC |
Viable Tissue |
Mean OD570 |
0.370 |
0.462 |
0.416 |
|
|
Viability (% of NC) |
19.1 |
23.9 |
21.5 |
3.3 |
15.6 |
* Negative values are set to zero for further calculation.
Brownish discoloration and minimal compound residues were observed on all test-substance treated tissues after the washing procedure.
Due to the intense color of the test substance, the ability of the test substance to directly reduce MTT could not be determined in a pretest. Therefore, KC tissues were applied in parallel. The results of the KC tissues indicate an increased MTT reduction (mean viability 0.7 % of NC). Thus for the test substance, the final mean viability is given after KC correction.
Table 4: Individual and ean OD570 values, individual and mean viability values, standard deviations and coefficient of variation
Exposue Time: 1 h |
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV (%) |
||
NC |
Viable Tissue |
Mean OD570 |
1.814 |
1.984 |
1.899 |
|
|
Viability (% of NC) |
95.5 |
104.5 |
100.0 |
6.3 |
6.3 |
||
KC Tissue |
Mean OD570 |
0.0889 |
0.089 |
0.089 |
|
|
|
Viability (% of NC) |
4.7 |
4.7 |
4.7 |
0.0 |
0.0 |
||
Test Substance |
Viable Tissue |
Mean OD570 |
1.832 |
1.838 |
1.835 |
|
|
Viability (% of NC) |
96.5 |
96.8 |
96.6 |
0.2 |
0.3 |
||
KC Tissue** |
Mean OD570 |
0.020 |
0.233 |
0.020 |
|
|
|
Viability (% of NC) |
1.1 |
12.3 |
1.1 |
|
|
||
**Final mean viability of tissues after KC correction (% of NC) |
95.6 |
|
|
||||
PC |
Viable Tissue |
Mean OD570 |
0.078 |
0.087 |
0.082 |
|
|
Viability (% of NC) |
4.1 |
4.6 |
4.3 |
0.3 |
7.3 |
** Mechanical damage of KC tissue No. 2 occurred during the washing procedure, thus, the result of KC tissue 2 is excluded from calculation of the mean value. Due to the unambiguous results, this deviation did not adversely affect the evaluation of the study.
Brownish discoloration and minimal compound residues were observed on all test-substance treated tissues after the washing procedure.
Due to the intense color of the test substance, the ability of the test substance to directly reduce MTT could not be determined in a pretest. Therefore, KC tissues were applied in parallel. The result of KC tissue 1 indicate an increased MTT reduction (viability 1.1 % of NC). Thus for the test substance, the final mean viability is given after KC correction.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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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