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EC number: 242-644-7 | CAS number: 18880-36-9
- 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: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-01-18 - 2016-02-16 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well-documented GLP OECD 439 guideline study on the registered substance itself without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- OECD Guideline for the Testing of Chemicals, Version 439, 28. July 2015, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- • EU method B.46 BIS. “IN VITRO SKIN IRRITATION: RECONSTRUCTED HUMAN EPIDERMIS MODEL TEST”, dated 24. Aug. 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, 55116 Mainz, Germany
Test material
- Reference substance name:
- Sodium 3-[[(dimethylamino)thioxomethyl]thio]propanesulphonate
- EC Number:
- 242-644-7
- EC Name:
- Sodium 3-[[(dimethylamino)thioxomethyl]thio]propanesulphonate
- Cas Number:
- 18880-36-9
- Molecular formula:
- C6H13NO3S3.Na
- IUPAC Name:
- sodium 3-[(dimethylcarbamothioyl)sulfanyl]propane-1-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): sodium 3-[[(dimethylamino)thioxomethyl]thio]propanesulphonate, DPS
- Substance type: pure substance
- Storage condition of test material: Room Temperature (20 ± 5°C)
- Other: Homogeneity: homogeneous
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis
- Details on test animals or test system and environmental conditions:
- Test System
Specification
Commercially available EpiDermTM-Kit.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell cultures inserts.
Origin
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati-slava.
Designation of the kit: EPI-200-SIT
Day of delivery: 09. Feb. 2016
Batch no.: 23312
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: DPBS-buffer was used as negative control, 5 % SDS solution was used as positive control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 24.7, 25.4, and 25.5 mg/plate - Duration of treatment / exposure:
- 60 min
- Observation period:
- 42.75h postincubation, 3h MTT incubation
- Number of animals:
- Each 1 plate with 3 tissues for negative and positive control and test item
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing with DPBS buffer
- Time after start of exposure: 60 min
SCORING SYSTEM: Formazan production as described in OECD Guideline 439
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Formazan production
- Value:
- 103.1
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 h incubation, 42h postincubation. Reversibility: other: not applicable. Remarks: Test item; above the threshold for skin irritation (50%).. (migrated information)
- Irritation / corrosion parameter:
- other: other: Formazan production
- Value:
- 3.7
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 h incubation, 42h postincubation. Reversibility: other: not applicable. Remarks: Positive control; below the threshold for skin irritation (50%).. (migrated information)
In vivo
- Irritant / corrosive response data:
- The relative absorbance values were increased to 101.3% after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as not irritant to skin.
Any other information on results incl. tables
Findings and Results
Measured Values
As blank, the optical density of isopropanol was measured in eight wells of the 96-well-plate. The measured values and their mean are given in the following table:
Table Absorbance values blank isopropanol (OD at 570 nm)
Replicate |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
Mean |
Absorbance |
0.040 |
0.039 |
0.039 |
0.039 |
0.038 |
0.039 |
0.044 |
0.038 |
0.040 |
The absorbance values of negative control, test item and positive control are given in the following table:
Table Absorbance Values negative control, test item and positive control (OD at 570 nm)
Designation |
Measurement |
Negative Control |
Test item |
Positive Control |
Tissue 1 |
1 |
1.837 |
1.729 |
0.103 |
2 |
1.793 |
1.835 |
0.096 |
|
Tissue 2 |
1 |
1.645 |
1.615 |
0.094 |
2 |
1.585 |
1.580 |
0.092 |
|
Tissue 3 |
1 |
1.510 |
1.609 |
0.105 |
2 |
1.473 |
1.600 |
0.104 |
From the measured absorbances, the mean of each tissue was calculated, subtracting the mean absorbance of isopropanol as given above. Mean and relative standard deviation (comparison of the three tissues) were also calculated.
Table Mean Absorbance Values
Designation |
Negative Control |
Test item |
Positive Control |
Mean – blank (tissue 1) |
1.775 |
1.742 |
0.060 |
Mean – blank (tissue 2) |
1.575 |
1.558 |
0.053 |
Mean – blank (tissue 3) |
1.452 |
1.565 |
0.065 |
Mean of the three tissues |
1.601 |
1.622 |
0.059 |
Comparison of Formazan Production
For the test item and the positive control, the following percentage values of formazan production were calculated in comparison to the negative control:
Table % Formazan Production
Designation |
Test item |
Positive Control |
% Formazan production (tissue 1) |
108.8% |
3.7% |
% Formazan production (tissue 2) |
97.3% |
3.3% |
% Formazan production (tissue 3) |
97.8% |
4.1% |
% Formazan production (mean) |
101.3% |
3.7% |
± SD of mean Formazan production (%) |
6.5% |
0.4% |
Assessment and Validity
Skin Irritation Potential of the Test Item
The relative absorbance values were increased to 101.3% after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as not irritant to skin.
Validity and Acceptability
Validity criteria and results are stated in the following table:
Table Validity
Criterion |
Demanded |
Found |
OD of negative control |
≥ 0.8 and ≤ 2.8 |
1.6 |
% Formazan production |
£20% of negative control |
3.7% |
SD of mean viability of the tissue replicates (%) |
≤ 18 |
10.2% (negative control) 0.4% (positive control) |
All validity criteria were met.
Values for negative control and for positive control were within the range of historical data of the test facility.
Therefore, the experiment is considered valid.Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Testing was performed via a GLP OECD 439 guideline study on the registered substance itself. The present in vitro method is recommended in a tiered testing approach, it was used as the first tier in a bottom-up approach, which may serve as a standalone test in case no indication of irritation was observed.
The validity criteria are met, making the results sufficiently reliable to assess the irritating potential of the test item to the skin. The present in vitro method allows the identification of irritating chemical substances and mixtures.
The relative absorbance values were increased to 101.3% after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as not irritant to skin. - Executive summary:
In an OECD 439 (in vitro skin irritation) study under GLP, two experiments were performed.
The first experiment was not valid, because the variation between the replicates of the negative control was too high. Therefore, the experiment was repeated and the results of the invalid experiment are not reported, but kept in the GLP archive of the test facility. The repetition of the experiment was valid.
Three tissues of the human skin model EpiDermTM were treated with sodium 3-[[(dimethylamino)thioxomethyl]thio]propanesulphonate, DPS for 60 min.
The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm²; as indicated by supplier).
DPBS-buffer was used as negative control, 5 % SDS solution was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.6. The positive control showed clear irritating effects. Relative absorbance was reduced to 3.7% (required: < 20%).
Variation within tissues was acceptable (required: ≤ 18 %).
After the treatment with the test item, the relative absorbance values were increased to 101.3%. This value is well above the threshold for irritation potential (50%).
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