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EC number: 812-222-2 | CAS number: 4443-23-6
- 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:
- key study
- Study period:
- 2018-06-14 to 2018-09-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- 29 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40bis (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(1,3-dioxo-2,3-dihydro-1H-isoindol-2-yl)ethane-1-sulfonamide
- EC Number:
- 812-222-2
- Cas Number:
- 4443-23-6
- Molecular formula:
- C10H10N2O4S
- IUPAC Name:
- 2-(1,3-dioxo-2,3-dihydro-1H-isoindol-2-yl)ethane-1-sulfonamide
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: no data
- Justification for test system used:
- As recommended by OECD guideline
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™
- Tissue batch number(s): EPI-200-SCT, Lot no. 28629
- Date of initiation of testing: 2018-06-19
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Not specified
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: one washing step, volume not specified
- 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: 3h
- Spectrophotometer: Tecan Sunrise Magellan Version 6.4
- Wavelength: 540 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD (540-570 nm) [1.0 -3.0]: Result: 1.884 ± 0.1525
- Barrier function: ET-50 assay, 100 µL 1% Triton X-100, 4 time-points, n = 3, MTT assay, ET-50 [4.77-8.72 h]: Result: 4.79 h
- Contamination: Longe term antibiotic and antimycotic free culture, No contamination: Result: Sterile
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- N. of replicates : 2
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%.
- 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(s) applied (volume or weight with unit): 25 mg moistened with 25 µL deionized water
VEHICLE
- Amount(s) applied (volume or weight with unit): Deionized water 25 µL
- Lot/batch no. (if required): 180958001
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL deionized water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL 8 N KOH - Duration of treatment / exposure:
- 1st period: 3 min
2nd period: 60 min - Duration of post-treatment incubation (if applicable):
- 3 h incubation with MTT
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3-minutes exposure
- Run / experiment:
- tissue 1
- Value:
- 103.1
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3-minutes exposure
- Run / experiment:
- tissue 2
- Value:
- 99.4
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60-minutes exposure
- Run / experiment:
- tissue 1
- Value:
- 103.3
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60-minutes exposure
- Run / experiment:
- tissue 2
- Value:
- 100.7
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Colour interference with MTT: No
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 if different from the ones specified in the test guideline:
Short time incubation – 3 min
Negative control: Mean OD 1.624 (2.5±2.4) Average viability [%] 100 (2.5 ± 2.4), Viability range [%]: 93.7–106.3; % difference 0.14–8.6, unqualified experiments: 0#1
8 N KOH: Mean OD0.126 (8.8±7.4) Average viability [%] 7.6 (8.8 ± 7.4), Viability range [%]: 2.0–15.6; % difference <0.01–23.7, unqualified experiments: 0
Long time incubation – 60 min
Negative control
Mean OD 1.650 (4.0±5.0), Average viability [%] 100 (4.0±5.0), Viability range [%]: 85.6–114.4; % difference 0.13–18.3, unqualified experiments: 0#1
8 N KOH
Mean OD 0.090 (5.7±9.8), Average viability [%] 5.9, Viability range [%]: (5.7 ± 9.8); % difference 2.0–12.6 0.30–38.4, unqualified experiments: 0#2
#1 Unqualified results = if the mean OD of the NC tissues is < 0.8 or > 2.8 if difference in viability for duplicate tissues > 30%
#2 Unqualified results = 8 N KOH: viability > 15% (1-h exposure)
Any other information on results incl. tables
Table 1: Viabilities after both exposure durations
|
Viability 3-minutes exposure |
Viability 60-minutes exposure |
||
|
Optical density [OD540] mean tissue 1 and 2 (percent differences) |
Mean viability (Difference of Viability) [%] |
Optical density [OD540] mean tissue 1 and 2 (percent differences) |
Mean viability (Difference of Viability) [%] |
Negative control (deionized water) |
1.564 |
100.0 |
1.606 |
100.0 |
|
(2.8) |
(2.7) |
(0.6) |
(0.5) |
TA-3 |
1.584 |
101.3 |
1.639 |
102.0 |
|
(3.7) |
(3.7) |
(2.5) |
(2.6) |
Positive control (8 N KOH) |
0.068 |
4.4 |
0.070 |
4.4 |
|
(11.8) |
(0.0) |
(0.0) |
(0.0) |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions of the study, the test item tested at two exposure periods of 3 minutes or 1 hour was non-cytotoxic and, hence, predicted to be non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin. Therefore, the test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to be not corrosive to the skin.
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