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EC number: 265-367-3 | CAS number: 65072-36-8
- 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 / corrosion, other
- Remarks:
- In vitro skin corrosion and skin irritation (combined) study.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 9-11 January, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- Adopted: 29 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Adopted: 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40 Bis (In vitro skin corrosion: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- No 440/2008, Annex Part B, Dated May 31st, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- No. 640/2012, Annex III, Dated 6 July, 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Lithium 2-aminobenzothiazole-6-sulphonate
- EC Number:
- 265-367-3
- EC Name:
- Lithium 2-aminobenzothiazole-6-sulphonate
- Cas Number:
- 65072-36-8
- Molecular formula:
- C7H6N2O3S2.Li
- IUPAC Name:
- lithium 2-amino-1,3-benzothiazole-6-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Bulk Density (g/ml): 0.39
- Particle size distribution (μm): 19.6
- Water solubility: 20%
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: IR2510181
- Expiration date of the lot/batch: 25 October 2019
- Purity test date: Not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature (15-25 °C, ≤70% relative
humidity)
- Stability under test conditions: Not specified
- Solubility and stability of the test substance in the solvent/vehicle: 20% soluble in water
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: 2-ABT lithium sulphonate was ground to a fine powder
- Preliminary purification step: Not specified
FORM AS APPLIED IN THE TEST
- 2-ABT lithium sulphonate was applied in its original form (although it was ground to a fine powder)
In vitro test system
- Test system:
- human skin model
- Remarks:
- EPISKIN™ (SM) model
- Source species:
- human
- Cell type:
- other: Normal human keratinocytes
- Cell source:
- other: Adult donors
- Source strain:
- other: Not applicable
- Details on animal used as source of test system:
- The donors blood verified:
- the absence of HIV1 and 2 antibodies
- the absence of hepatitis C antibodies
- the absence of hepatitis B antigen HBs
The donors epidermal cells verified:
- the absence of bacteria, fungus and mycoplasma - Justification for test system used:
- The EPISKIN™(SM) model has been validated for corrosivity and irritation testing in
an international validation study and its use is recommended by the relevant OECD
guidelines for corrosivity and irritation testing (OECD No. 431 and OECD No. 439);
therefore, it was considered to be suitable for this study. - Vehicle:
- other: Irritation test: 10 μl of distilled water was applied to the epidermal surface before the addition of 10 mg 2-ABT lithium sulphonate
- Remarks:
- Corrosivity test: 100 μl of physiological saline was added to 2-ABT lithium sulphonate after it had been applied to the epidermal surface
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN™(SM)
- Tissue batch number(s): 19-EKIN-001
- Production date: Not specified
- Shipping date: Not specified
- Delivery date: Not specified
- Date of initiation of testing: 9 January, 2019
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure:
Irritation test: 24.0-24.9 °C
Corrosivity test: 23.2-24.0 °C
- Temperature of post-treatment incubation:
Irritation test: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 1 washing step using phoshpate buffered saline (volume not specified)
- Observable damage in the tissue due to washing: Not specified
- Modifications to validated SOP: Not specified
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 2 mL of 0.3 mg/mL MTT working solution
- Incubation time: 3 hours
- Spectrophotometer: Manufacturer: Thermo Fisher Scientific, Catalogue Number: 240 72800, Serial Number: 0920-14, Date of calibration: 13 August 2018, calibration is valid until August 2020
- 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
- Viability:
Irritation test: phosphate buffered saline optical density = 0.784
Corrosivity test: physiological saline optical density = 0.849
- Barrier function:
IC50 (SDS concentration, MTT test) = 2.3 mg/mL
- Morphology:
Histology scoring (HES stained vertical paraffin sections) - result: 23.3 ± 0.3 (CV = 1.2%)
Well-differentiated epidermis consisting of a basal layer, several spinous and granular layers and a thick stratum corneum - result: satisfactory
- Contamination:
Blood:
absence of HIV1 and 2 antibodies
absence of hepatitis C antibodies
absence of hepatitis B antigen HBs
Epidermis:
absence of bacteria, fungus and mycoplasma
- Reproducibility: Not specified
NUMBER OF REPLICATE TISSUES:
- Irritation test: three replicate epidermis units
- Corrosivity test: two replicate epidermis units
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Living tissue - Reconstructed human epidermis (EPISKIN™(SM) model)
- No. of replicates : Four (irritation test: 2, corrosivity test: 2)
- Method of calculation used: Optical density measured at 570 nm
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be non-corrosive to skin if the mean cell viability for both skin units is greater than or equal to 35% of the negative control after 4 hours of exposure
- The test substance is considered to be non-irritating to skin if the mean cell viability for all three skin units is greater than 50% of the mean viability of the negative controls after 15 minutes of exposure and 42 hours post-incubation - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- other: yes, MTT control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied:
Irritation test: 10 mg
Corrosivity test: 20 mg
NEGATIVE CONTROL
- Amount(s) applied:
Irritation test: 50 µL of phosphate buffered saline
Corrosivity test: 50 µL of physiological saline (0.9% (w/v) NaCl solution)
POSITIVE CONTROL
- Amount(s) applied:
Irritation test: 50 µL of 5% (w/v) sodium dodecyl sulphate solution
Corrosivity test: 50 µL glacial acetic acid - Duration of treatment / exposure:
- Irritation test: 15 minutes
Corrosivity test: 4 hours - Duration of post-treatment incubation (if applicable):
- Irritation test: 42 hours (±1 hour)
- Number of replicates:
- Irritation test: 3 reconstructed epidermis units (area: 0.38 cm²) each for 2-ABT lithium sulphonate, the positive control and the negative control
Corrosivity test: 2 reconstructed epidermis units (area: 0.38 cm²) each for 2-ABT lithium sulphonate, the positive control and the negative control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: % mean cell viability
- Run / experiment:
- Irritation testing: 10 mg 2-ABT lithium sulphonate was applied 3 reconstructed epidermis units for 15 minutes at room temperature (24.0-24.9°C).
- Value:
- 91.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100% mean cell viability obtained with phosphate buffered saline (50 μl)
- Positive controls validity:
- valid
- Remarks:
- 5.3% mean cell viability obtained with 5% (w/v) sodium dodecyl sulphate solution (50 μl)
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- other: % mean cell viability
- Run / experiment:
- Corrosivity testing: 20 mg 2-ABT lithium sulphonate was applied to 2 reconstructed epidermis units for 4 hours at room temperature (23.2-24.0°C).
- Value:
- 97.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100% mean cell viability obtained with 50 μl physiological saline (0.9% (w/v) NaCl)
- Positive controls validity:
- valid
- Remarks:
- 1.1% mean cell viability obtained with glacial acetic acid (50 μl)
- Remarks on result:
- other: no indication of corrosivity
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vitro reconstructed human epidermis (EPISKIN™ (SM) model) test, conducted according to OECD test guidelines 431 and 439 and to GLP, lithium 2-aminobenzothiazole-6-sulphonate was determined to be non-corrosive and non-irritating to the skin.
- Executive summary:
In an in vitro study, conducted according to OECD test guidelines 431 and 439 and to GLP, lithium 2-aminobenzothiazole-6-sulphonate was applied to an EPISKIN™ (SM) reconstructed human epidermis model to assess its potential to cause skin irritation and/or corrosion.
In the irritation study, three reconstructed epidermis units were exposed to 10 mg lithium 2-aminobenzothiazole-6-sulphonate for 15 minutes at room temperature. The units were then rinsed using phosphate buffered saline and incubated at 37 °C for 42 hours. In the corrosivity study, two reconstructed epidermis units were exposed to 20 mg lithium 2-aminobenzothiazole-6-sulphonate for 4 hours at room temperature and then rinsed using phosphate buffered saline.
In both tests, MTT (2 mL of 0.3 mg/mL MTT working solution) was added to each epidermis unit and the units were incubated at 37 °C for 3 hours. The mean cell viability was calculated by assessing the optical density of the samples using a plate reader at 570 nm. In the irritation and corrosivity tests, the mean cell viability was calculated to be 91.8 and 97.6%, respectively.
In this reliable in vitro study, lithium 2-aminobenzothiazole-6-sulphonate was determined to be non-corrosive and non-irritating to human reconstructed epidermis.
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