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EC number: 201-161-1 | CAS number: 78-95-5
- 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
Endpoint summary
Administrative data
Description of key information
The test item was determined to be corrosive to skin (reference 7.3.1-1).
A study for eye irritation does not need to be conducted as the test item is classified for skin corrosion (reference 7.3.2-1).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020-12-01 to 2020-12-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Council Regulation 440/2008, Method B.40 BIS: “In Vitro Skin Corrosion: Human Skin Model Test”
- Version / remarks:
- May 30, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 18 June, 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: donors not further specified, consent was obtained
- Justification for test system used:
- The EpiDerm Skin Model is a well-established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: reconstituted three-dimensional human skin model EpiDerm
- Tissue batch number: 34106
- Production date: not specified
- Shipping date: not specified
- Delivery date: not specified
- Date of initiation of testing: 2020-12-01
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 min treatment: room temperature; 60 min treatment: 37 ± 1 °C
- Temperature of post-treatment incubation: 37 ± 1 °C,
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: gently rinsed about 20 times with PBS
- Observable damage in the tissue due to washing: No
- Modifications to validated SOP: No
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL medium
- Incubation time: 3 h
- Spectrophotometer: plate spectrophotometer
- Wavelength: 570 nm
- Filter: not specified
- Filter bandwidth: not specified
- Linear OD range of spectrophotometer: not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
As provided on CoA for tissue lot:
- Viability: Acceptance criteria: OD 1.0-3.0; result: 1.654+/-0.2
- Barrier function: Acceptance criteria: ET-50 4.77-8.72 h; result: 6.59 h
- Contamination: Acceptance criteria: no contamination; result: sterile
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2
PREDICTION MODEL / DECISION CRITERIA
- 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%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is greater than or equal to 15 %. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 μL
NEGATIVE CONTROL
- Amount applied: 50 μL
POSITIVE CONTROL
- Amount applied: 50 μL - Duration of treatment / exposure:
- 3 and 60 min
- Duration of post-treatment incubation (if applicable):
- 3 h
- Number of replicates:
- 2
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure
- Value:
- 9.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100
- Positive controls validity:
- valid
- Remarks:
- 8.6
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 46.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100
- Positive controls validity:
- valid
- Remarks:
- 13.7
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS
- Visible damage on test system: No
- Direct-MTT reduction: The mixture of 50 μL test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent.
- Colour interference with MTT: The mixture of 50 μL test item per 300 μL Aqua dest. and per 300 μL isopropanol showed no relevant colouring as compared to the solvent.
DEMONSTRATION OF TECHNICAL PROFICIENCY: not specified
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
- Range of historical values: Please refer to "Any other information on results" - Conclusions:
- The test item was determined to be corrosive to skin.
- Executive summary:
A study according to OECD 431 was conducted to assess the skin corrosivity potential the test item. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EpiDerm, a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
The mixture of 50 μL test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0 %.
The mixture of 50 μL test item per 300 μL Aqua dest. and per 300 μL isopropanol showed no colouring as compared to the solvent. Therefore, NSC equalled 0 %.
The test item showed no non-specific reduction of MTT and no relevant colouring potential after mixture with aqua dest. and with isopropanol. Therefore, no additional controls for correction of possible false-negative results were necessary.
The controls confirmed the validity of the study. The mean OD570nm of the two negative control tissues was ≥ 0.8 and ≤ 2.8 for each exposure period (2.038, 2.042). The mean relative tissue viability (% negative control) of the positive control was ≤ 15 % (8.6 %) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100 % viability) of replicate tissues of all dose groups was ≤ 30 % (3.3 % - 10.0 %).
The test item showed corrosive effects. The mean relative tissue viability (% negative control) was reduced to 46.5 % after 3 min treatment and to 9.2 % after 60 min exposure to the test item.
Reference
Table 1: Results of 3 min Experiment
Name |
Negative Control |
Positive Control |
Test Item |
|||
Replicate Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
2.414 |
1.891 |
0.316 |
0.312 |
1.039 |
0.898 |
1.693 |
1.930 |
0.321 |
0.309 |
1.035 |
0.914 |
|
2.392 |
1.910 |
0.331 |
0.314 |
1.041 |
0.908 |
|
Mean Absolute OD570 |
2.038**** |
0.317 |
0.972 |
|||
OD570 - Blank Corrected |
2.370 |
1.847 |
0.272 |
0.268 |
0.995 |
0.853 |
1.649 |
1.866 |
0.277 |
0.265 |
0.990 |
0.870 |
|
2.348 |
1.866 |
0.287 |
0.270 |
0.997 |
0.864 |
|
Mean OD570 of 3 Aliquots (Blank Corrected) |
2.122 |
1.866 |
0.278 |
0.268 |
0.994 |
0.862 |
SD OD570 of 3 Aliquots |
0.410 |
0.020 |
0.008 |
0.002 |
0.003 |
0.008 |
Total Mean OD570 of 2 Replicate Tissues (Blank Corrected) |
1.994* |
0.273 |
0.928 |
|||
SD OD570 of 2 Replicate Tissues |
0.181 |
0.0088 |
0.093 |
|||
Mean Relative Tissue Viability [%] |
100.0 |
13.7 |
46.5 |
|||
Coefficient Of Variation [%]*** |
9.1 |
2.8 |
10.00 |
* corrected mean OD570 of the negative control corresponds to 100 % absolute tissue viability
*** coefficient of variation (CV) (in the range of 20 – 100 % viability) between two tissues treated identically is ≤ 30 %
**** The mean absolute OD570 of the negative control is ≥ 0.8 and ≤ 2.8
Table 2: Results of 60 min Experiment
Name |
Negative Control |
Positive Control |
Test Item |
|||
Replicate Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
2.038 |
2.070 |
0.252 |
0.173 |
0.227 |
0.221 |
1.963 |
2.094 |
0.259 |
0.179 |
0.234 |
0.224 |
|
1.985 |
2.099 |
0.257 |
0.175 |
0.235 |
0.225 |
|
Mean Absolute OD570 |
2.042**** |
0.216 |
0.228 |
|||
OD570 - Blank Corrected |
1.994 |
2.026 |
0.208 |
0.129 |
0.183 |
0.177 |
1.919 |
2.050 |
0.215 |
0.134 |
0.190 |
0.180 |
|
1.941 |
2.055 |
0.212 |
0.131 |
0.191 |
0.181 |
|
Mean OD570 of 3 Aliquots |
1.951 |
2.043 |
0.212 |
0.132 |
0.188 |
0.179 |
SD OD570 of 3 Aliquots |
0.038 |
0.015 |
0.003 |
0.003 |
0.005 |
0.002 |
Total Mean OD570 of 2 Replicate Tissues (Blank Corrected) |
1997* |
0.172 |
0.184 |
|||
SD OD570 of 2 Replicate Tissues |
0.065 |
0.057 |
0.006 |
|||
Mean Relative Tissue Viability [%] |
100.0 |
8.6** |
9.2 |
|||
Coefficient Of Variation [%]*** |
3.3 |
33.1 |
3.4 |
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability
** mean relative tissue viability of the 60 min positive control is ≤ 15 %
*** coefficient of variation (CV) (in the range of 20 – 100 % viability) between two tissues treated identically is ≤ 30 %
**** The mean absolute OD570 of the negative control is ≥ 0.8 and ≤ 2.8
Table 3: Test Acceptance Criteria
|
Value |
Cut off |
Pass/fall |
Mean Absolute OD570 nm NC (3 min Experiment) |
2.038 |
0.8 ≤ NC ≤ 2.8 |
pass |
Mean Absolute OD570 nm NC (60 min Experiment) |
2.042 |
0.8 ≤ NC ≤ 2.8 |
pass |
Mean Relative Tissue Viability [%] of PC (60 min experiment) |
8.6 |
≤ 15 % |
pass |
CV [%] (in the range of 20 – 100 % viability) |
3.3 – 10.0 |
≤ 30% |
pass |
Table 4: Historical Data
|
Mean |
SD |
Range of LCL – UCL |
n |
OD570 of NC |
1.749 |
0.225 |
1.298 – 2.199 |
60 |
OD570 of NC (60 min Experiment) |
1.800 |
0.202 |
1.395 – 2.204 |
61 |
Relative Tissue Viability [%] of PC (60 min experiment) |
5.8 |
2.2 |
1.3 – 10.3 |
61 |
CV [%] (in the range of 20 – 100 % viability) |
7.1 |
10.7 |
0.0 – 28.6 |
300 |
LCL: Lower control limit (95 %, mean – 2*SD)
UCL: Upper control limit (95 %, mean + 2*SD)
n: number of control values
Historical control data were generated from 2015 - 2020.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin corrosion
A study according to OECD 431 was conducted to assess the skin corrosivity potential the test item. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EpiDerm, a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
The mixture of 50 μL test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0 %.
The mixture of 50 μL test item per 300 μL Aqua dest. and per 300 μL isopropanol showed no colouring as compared to the solvent. Therefore, NSC equalled 0 %.
The test item showed no non-specific reduction of MTT and no relevant colouring potential after mixture with aqua dest. and with isopropanol. Therefore, no additional controls for correction of possible false-negative results were necessary.
The controls confirmed the validity of the study. The mean OD570nm of the two negative control tissues was ≥ 0.8 and ≤ 2.8 for each exposure period (2.038, 2.042). The mean relative tissue viability (% negative control) of the positive control was ≤ 15 % (8.6 %) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100 % viability) of replicate tissues of all dose groups was ≤ 30 % (3.3 % - 10.0 %).
The test item showed corrosive effects. The mean relative tissue viability (% negative control) was reduced to 46.5 % after 3 min treatment and to 9.2 % after 60 min exposure to the test item.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin corrosion, the test item is classified for skin corrosion Category 1 (H314: Causes severe skin burns and eye damage) and therefore also for causing serious damage to the eye Category 1 according to Regulation (EC) No 1272/2008 (CLP), as amended for the seventeenth time in Regulation (EU) 2021/849.
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