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EC number: 500-263-6 | CAS number: 77138-45-5
- 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
Corrosive to skin, Category 1B.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EPISKIN™ Reconstructed Human Epidermis Model Kit
Supplier : MatTek
Date received : 24 May 2016
EpiSkinTM Tissues (0.38cm2) lot number : 23338
Maintenance Medium lot number : 051916TMA - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 uL
- Duration of treatment / exposure:
- 3 minutes
60 minutes - Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- 61.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- 2.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- The test item was considered to be corrosive to the skin.
- Executive summary:
Introduction
The purpose of this test is to evaluate the corrosivity potential of the test item using the EpiDerm™ Human Skin Model after treatment periods of 3 and 60 minutes.
Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are used to make a prediction of the corrosivity potential of the test item.
Methods
Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. The test item was found to directly reduce MTT and therefore additional non-viable tissues were incorporated into the testing for correction purposes. Negative and positive control groups were treated for each exposure period. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading each tissue was placed in 2 mL Isopropanol for MTT extraction.
At the end of the formazan extraction period each well was mixed thoroughly and triplicate 200 μL samples were transferred to the appropriate wells of a pre-labeled 96-well plate. The optical density (OD) was measured at 562 nm (OD562).
Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
Results
The relative mean viabilities for each treatment group were as follows:
Exposure Period Percentage Viability
Negative Control Positive Control Test Item
3 minute 100* 5.1 61.6
60 minute 100* 4.7 2.6
*The mean viability of the negative control tissues is set at 100%
Quality criteria: The quality criteria required for acceptance of results in the test were satisfied.
Conclusion
The test item was considered to be corrosive to the skin.
Reference
Tissue |
Exposure Period |
Mean OD562of individual tissues (tvt) |
Mean OD562of duplicate tissues |
Corrected OD562of tissues (tvt -[tktukt]) |
Standard Deviation |
Coefficient of Variation (%) |
Relative Mean Viability (%) |
Negative Control⊕ |
3 Minutes |
1.720 |
1.835 |
|
0.162 |
8.8 |
100* |
1.949 |
|
||||||
60 Minutes |
1.872 |
1.838 |
|
0.048 |
2.6 |
||
1.804 |
|
||||||
Positive Control⊕ |
3 Minutes |
0.100 |
0.094 |
|
0.009 |
N/A |
5.1 |
0.087 |
|
||||||
60 Minutes |
0.090 |
0.087 |
|
0.005 |
N/A |
4.7 |
|
0.083 |
|
||||||
Test Item |
3 Minutes |
1.347 |
1.415 |
1.130 |
0.095 |
6.7 |
61.6 |
1.482 |
|||||||
60 Minutes |
0.562 |
0.409 |
0.048 |
0.216 |
N/A |
2.6 |
|
0.256 |
3 minute exposure corrected mean OD562= 0.412 (tkt) – 0.127 (ukt) = 0.285
60 minute exposure corrected mean OD562= 0.474 (tkt) – 0.113 (ukt) = 0.361
tvt = treated viable tissues
tkt = treated killed tissues
ukt = untreated killed tissues
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Additional information
Justification for classification or non-classification
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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