Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
Reaction mass of sodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)
EC number: 915-758-6 | 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:
- 2016-06-22 to 2017-06-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2016-06-22 to 2017-06-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015-07-28
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: N01-131001
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS: Solid / dark brown, pH ca. 5 (undiluted test substance, moistened with de-ionized water; determined in the lab prior to start of the GLP study) - 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
- Tissue lot number: 23343
- Date of initiation of testing: 2016-06-28
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 25 min at room temperature, 35 min at 37 °C (Incubator)
- Temperature of post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The tissues were washed with sterile PBS to remove residual test material 1 hour after start of application. Rinsed tissues were blotted on sterile absorbent paper and transferred into new 6-well plates pre-filled with 0.9 mL fresh medium. When all tissues were rinsed the surface of each tissue was carefully dried with a sterile cotton swab.
- 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: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues
- Procedure used to prepare the killed tissues: freezing
- N. of replicates : 3
- Method of calculation used:
Principle: The OD570 values determined for the various tissues are measures of their viability. The quotient of the OD570 of tissues treated with the test material and the mean OD570 values of the NC (percent of control) is used for evaluating whether a test material is corrosive or irritant.
Calculation of individual and mean optical densities: The individual tissue OD570 is calculated by subtracting the mean blank value of the respective microtiter plate from the respective individual tissue OD570 value. The mean OD570 for a test group of three tissues treated in the same way was calculated.
Application of measurements using killed control tissues: In case of direct MTT reduction by the test substance, the OD570 values measured in the freeze-killed control tissues (KC) will be used to correct the mean OD570 of the tissues treated with the test substance (mean OD570 KC corrected). Since killed tissue might still have a residual enzyme activity that is able to produce some formazan net OD570 KC is calculated by subtracting the OD570 KC of the NC from the OD570 KC of the test substance. In case the net OD570 KC is greater than zero it is subtracted from the respective mean OD570 to result in the mean OD570 KC corrected. The mean OD570 KC corrected represents the formazan production linked to the tissue viability and therefore indicates the cytotoxic potency of the test substance.
Application of measurements using color control tissues: The OD570 values measured in the color control tissues (CC) was used to correct the mean OD570 of the test-substance treated tissues (mean OD570 CC corrected). The mean net OD570 CC was subtracted from the respective mean OD570 to result in the mean OD570 CC corrected, only when interference of the test substance in the colorimetric test is noticed. The mean OD570 CC corrected represents the formazan production without the absorbance of the colored test substance.
Tissue viability: The quantification of tissue viability is presented as the quotient of the mean OD570 (or mean OD570 KC corrected, if applicable) divided by the respective OD570 NC value in percent for each exposure time.
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritating to skin if the mean relative tissue viability with a test material is less than or equal to 50 %. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 25 µL deionized water + 25 µL test substance (bulk volume)
NEGATIVE CONTROL
- Amount applied: 30 µL
POSITIVE CONTROL
- Amount applied: 30 µL
- Concentration: 5 % (w/v) in water - Duration of treatment / exposure:
- 1 h
- Duration of post-treatment incubation (if applicable):
- 42 h ± 4 h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 95
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: Due to the color of the test substance, it could not be determined whether the test substance can directly reduce MTT. Therefore, an additional MTT reduction control (freeze-killed control tissues (KC)) was introduced.
- Colour interference with MTT: In a pretest, it was demonstrated that the color of the test substance interferes with the colorimetric test. Therefore, color controls (viable tissues CC) and freeze-killed control tissues (KC CC) were performed to differentiate formazan produced by the cells in the MTT test from color residues of the test substance in the colorimetric test.
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 - Interpretation of results:
- GHS criteria not met
Table 4: Individual and mean OD570 values, individual and mean viability values, standard deviations and coefficient of variation
|
|
|
Tissue 1 |
Tissue 2 |
Tissue 3 |
Mean |
SD |
CV (%) |
NC |
Viable Tissue |
Mean OD570 |
2.268 |
2.194 |
2.033 |
2.165 |
|
|
Viability (% of NC) |
104.7 |
101.3 |
93.9 |
100.0 |
5.5 |
5.5 |
||
KC Tissue |
Mean OD570 |
0.055 |
0.051 |
0.066 |
0.057 |
|
|
|
Viability (% of NC) |
2.5 |
2.3 |
3.0 |
2.6 |
0.4 |
13.7 |
||
Test Substance |
Viable Tissue |
Mean OD570 |
2.140 |
2.079 |
1.988 |
2.069 |
|
|
Viability (% of NC) |
98.8 |
96.0 |
91.8 |
95.6 |
3.5 |
3.7 |
||
CC Tissue |
Mean OD570 |
0.009 |
0.013 |
0.014 |
0.012 |
|
|
|
Viability (% of NC) |
0.4 |
0.6 |
0.6 |
0.6 |
0.1 |
20.4 |
||
Mean viability of Tissues after CC correction (%of NC) |
95.0 |
|
|
|||||
KC Tissue |
Mean OD570 |
0.018 |
0.017 |
0.019 |
0.018 |
|
|
|
Viability (% of NC) |
0.8 |
0.8 |
0.9 |
0.8 |
0.1 |
7.1 |
||
KC CC Tissue |
Mean OD570 |
0.029 |
0.034 |
0.035 |
0.032 |
|
|
|
Viability (% of NC) |
1.3 |
1.5 |
1.6 |
1.5 |
0.1 |
9.1 |
||
Mean Viability of KC Tissues after KC CC correction |
0.0 |
|
|
|||||
Final Mean Viability of Tissues after KC and CC correction (% of NC) |
95.0 |
|
|
|||||
PC |
Viable Tissues |
Mean OD570 |
0.052 |
0.053 |
0.051 |
0.052 |
|
|
Viability (% of NC) |
2.4 |
2.4 |
2.4 |
2.4 |
0.0 |
1.5 |
* Negative values are set to zero for further calculation.
Brown discoloration of the test-substance treated tissues was noticed after the washing procedure.
The results of the color control (CC) tissues indicate interference due to the color of the test substance (mean value 0.6% of NC). The results of the KC tissues did not indicate an increased MTT reduction. Thus for the test substance the final mean viability is given after CC correction only.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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 sodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)
- EC Number:
- 915-758-6
- Molecular formula:
- C32H18CrN6O8.Na / C32H22CrN10O8.Na / C32H20CrN8O8.Na
- IUPAC Name:
- Reaction mass of sodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(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: N01-131001
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS: Solid / dark brown, pH ca. 5 (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: 23343
- Date of initiation of testing: 2016-06-28
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:
Principle: The OD570 values determined for the various tissues are measures of their viability. The quotient of the OD570 of tissues treated with the test material and the mean OD570 values of the NC (percent of control) is used for evaluating whether a test material is corrosive or irritant.
Calculation of individual and mean optical densities: The individual tissue OD570 is calculated by subtracting the mean blank value of the respective microtiter plate from the respective individual tissue OD570 value. The mean OD570 for a test group of two tissues treated in the same way was calculated.
Application of measurements using killed control tissues: In case of direct MTT reduction by the test substance, the OD570 values measured in the freeze-killed control tissues (KC) will be used to correct the mean OD570 of the tissues treated with the test substance (mean OD570 KC corrected). Since killed tissue might still have a residual enzyme activity that is able to produce some formazan net OD570 KC is calculated by subtracting the OD570 KC of the NC from the OD570 KC of the test substance. In case the net OD570 KC is greater than zero it is subtracted from the respective mean OD570 to result in the mean OD570 KC corrected. The mean OD570 KC corrected represents the formazan production linked to the tissue viability and therefore indicates the cytotoxic potency of the test substance.
Application of measurements using color control tissues: The OD570 values measured in the color control tissues (CC) was used to correct the mean OD570 of the test-substance treated tissues (mean OD570 CC corrected). The mean net OD570 CC was subtracted from the respective mean OD570 to result in the mean OD570 CC corrected, only when interference of the test substance in the colorimetric test is noticed. The mean OD570 CC corrected represents the formazan production without the absorbance of the colored test substance.
Tissue viability: The quantification of tissue viability is presented as the quotient of the mean OD570 (or mean OD570 KC corrected, if applicable) divided by the respective OD570 NC value in percent for each exposure time.
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
- yes, concurrent MTT non-specific colour 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:
- 84.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Value after KC and CC correction
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h
- Value:
- 108.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Value after KC and CC correction
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: Due to the color of the test substance, it could not be determined whether the test substance can directly reduce MTT. Therefore, an additional MTT reduction control (freeze-killed control tissues (KC)) was introduced.
- Colour interference with MTT: In a pretest, it was demonstrated that the color of the test substance interferes with the colorimetric test. Therefore, color controls (viable tissues CC) and freeze-killed control tissues (KC CC) were performed to differentiate formazan produced by the cells in the MTT test from color residues of the test substance in the colorimetric test.
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 mean OD570 values, individual and mean viability values, standard deviations and coefficient of variation
3 min |
|
|
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV (%) |
NC |
Viable Tissue |
Mean OD570 |
2.051 |
1.964 |
2.007 |
|
|
Viability (% of NC) |
102.2 |
97.8 |
100.0 |
3.1 |
3.1 |
||
KC Tissue |
Mean OD570 |
0.083 |
0.095 |
0.089 |
|
|
|
Viability (% of NC) |
4.1 |
4.7 |
4.4 |
0.4 |
9.2 |
||
Test Substance |
Viable Tissue |
Mean OD570 |
1.802 |
1.599 |
1.701 |
|
|
Viability (% of NC) |
89.8 |
79.7 |
84.7 |
7.2 |
8.4 |
||
CC Tissue |
Mean OD570 |
0.010 |
0.009 |
0.010 |
|
|
|
Viability (% of NC) |
0.5 |
0.4 |
0.5 |
0.0 |
7.4 |
||
Mean viability of Tissues after CC correction (%of NC) |
84.3 |
|
|
||||
KC Tissue |
Mean OD570 |
0.006 |
0.012 |
0.009 |
|
|
|
Viability (% of NC) |
0.3 |
0.6 |
0.4 |
0.2 |
51.1 |
||
KC CC Tissue |
Mean OD570 |
0.034 |
0.010 |
0.022 |
|
|
|
Viability (% of NC) |
1.7 |
0.5 |
1.1 |
0.8 |
77.1 |
||
Mean Viability of KC Tissues after KC CC correction |
0.0 |
|
|
||||
Final Mean Viability of Tissues after KC and CC correction (% of NC) |
84.3 |
|
|
||||
PC |
Viable Tissues |
Mean OD570 |
0.284 |
0.188 |
0.236 |
|
|
Viability (% of NC) |
14.1 |
9.3 |
11.7 |
3.4 |
28.8 |
* Negative values were set to zero for further calculation.
The results of the color control (CC) tissues indicate interference due to the color of the test substance (mean value 0.5 % of NC). The results of the KC tissues did not indicate an increased MTT reduction. Thus for the test substance the final mean viability is given after CC correction, only.
Table 4: Individual and mean OD570 values, individual and mean viability values, standard deviations and coefficient of variation
1 h |
|
|
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV (%) |
NC |
Viable Tissue |
Mean OD570 |
1.736 |
1.717 |
1.726 |
|
|
Viability (% of NC) |
100.6 |
99.4 |
100.0 |
0.8 |
0.8 |
||
KC Tissue |
Mean OD570 |
0.086 |
0.099 |
0.092 |
|
|
|
Viability (% of NC) |
5.0 |
5.7 |
5.3 |
0.6 |
10.3 |
||
Test Substance |
Viable Tissue |
Mean OD570 |
1.898 |
1.934 |
1.916 |
|
|
Viability (% of NC) |
109.9 |
112.0 |
111.0 |
1.5 |
1.3 |
||
CC Tissue |
Mean OD570 |
0.043 |
0.051 |
0.047 |
|
|
|
Viability (% of NC) |
2.5 |
3.0 |
2.7 |
0.3 |
12.0 |
||
Mean viability of Tissues after CC correction (%of NC) |
108.2 |
|
|
||||
KC Tissue |
Mean OD570 |
0.029 |
0.028 |
0.029 |
|
|
|
Viability (% of NC) |
1.7 |
1.6 |
1.7 |
0.0 |
1.2 |
||
KC CC Tissue |
Mean OD570 |
0.049 |
0.113 |
0.081 |
|
|
|
Viability (% of NC) |
2.8 |
6.5 |
4.7 |
2.6 |
56.5 |
||
Mean Viability of KC Tissues after KC CC correction |
0.0 |
|
|
||||
Final Mean Viability of Tissues after KC and CC correction (% of NC) |
108.2 |
|
|
||||
PC |
Viable Tissues |
Mean OD570 |
0.088 |
0.111 |
0.99 |
|
|
Viability (% of NC) |
5.1 |
6.4 |
5.7 |
0.9 |
16.0 |
* Negative values are set to zero for further calculation .
Brown discoloration of the test-substance treated tissues was noticed after the washing procedure.
The results of the color control (CC) tissues indicate interference due to the color of the test substance (mean value 2.7 % of NC). The results of the KC tissues did not indicate an increased MTT reduction. Thus for the test substance the final mean viability is given after CC correction only.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.