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Diss Factsheets
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EC number: - | CAS number: -
- 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:
- 15 April 2020 - 17 July 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- 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 material
- Reference substance name:
- Benzenesulfonic acid, mono-C9-13-branched alkyl derivs., compds. with isopropylamine
- IUPAC Name:
- Benzenesulfonic acid, mono-C9-13-branched alkyl derivs., compds. with isopropylamine
- Test material form:
- liquid
- Details on test material:
- Molecular weight: 357.269
Appearance: light amber viscous liquid
Storage conditions: room temperature, in the dark
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Not specified
- Justification for test system used:
- According to OECD guideline 431
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
Model used: EpiDerm Reconstucted Human Epidermis
Tissue batch number: 30867
CoA signed: 20 May 2020
TEMPERATURE USED FOR TEST SYSTEM
Temperature used during treatment / exposure: 37 °C, 5% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
Rinsing was achieved by filling and emptying each tissue under a constant soft stream of Dulbecco’s Phosphate Buffered Saline (DPBS) (without Ca++ Mg++) for approximately 40 seconds, to gently remove any residual test item. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
MTT concentration: A 1.0 mg/mL MTT solution was prepared from a MatTek MTT-100 kit immediately prior to usage.
Incubation time: 3-Minute and 60-Minute exposure periods
Spectrophotometer: Absorbency at 570 nm (OD570) of each well was measured using the Labtech LT-4500 microplate reader and LT-com analysis software.
NUMBER OF REPLICATE TISSUES:
Two replicate tissues
PREDICTION MODEL / DECISION CRITERIA
Viability Measured after Exposure Time Points: Prediction to be considered according to EU CLP Regulation (EC) No 1272/2008 UN GHS
STEP 1
< 50% after 3 min exposure : Corrosive
≥ 50% after 3 min exposure AND < 15% after 60 min exposure: Corrosive
≥ 50% after 3 min exposure AND ≥ 15% after 60 min exposure: Non-corrosive
STEP 2 for test items identified as corrosive in step 1
< 25% after 3 min exposure: H314 (Sub-category 1A)
≥ 25% after 3 min exposure: H314 (Combination of sub-categories 1B-and-1C) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- For test item, positive and negative control: 50 µL applied
- Duration of treatment / exposure:
- 3-Minute and 60-Minute exposure periods
- Number of replicates:
- Two replicate tissues for the test item, positive and negative control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute (mean)
- Value:
- 84.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minute (mean)
- Value:
- 62.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mean OD570 for the negative control treated tissues was 2.005 for the 3-Minute exposure period and 2.062 for the 60-Minute exposure period. The negative control acceptance criteria were therefore satisfied.
The relative mean tissue viability for the positive control treated tissues was 2.9% relative to the negative control following the 60-Minute exposure period. The positive control acceptance criterion was therefore satisfied.
In the range 20 to 100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied.
Any other information on results incl. tables
The relative mean viabilities for each treatment group were as follows:
Exposure Period | Percentage Viability | ||
Negative Control | Positive Control | Test Item | |
3 minute | 100* | 3.3 | 84.3 |
60 minute | 100* | 2.9 | 62.5 |
Mean OD570values and viabilities for the negative control, positive control and test item are given in Appendix 1 (appended to attached background material) and replicated in the table below:
Tissue | Exposure Period | Mean OD570 of individual tissues | Mean OD570 of duplicate tissues | Standard Deviation | Coefficient of Variation (%) | Relative Mean Viability (%) |
Negative Control | 3 minutes | 1.621 | 2.005 | 0.543 | 27.1 | 100* |
2.389 | ||||||
60 minutes | 2.030 | 2.062 | 0.045 | 2.2 | ||
2.093 | ||||||
Positive Control | 3 minutes | 0.065 | 0.066 | 0.001 | N/A | 3.3 |
0.066 | ||||||
60 minutes | 0.059 | 0.059 | 0.000 | N/A | 2.9 | |
0.059 | ||||||
Test Item | 3 minutes | 1.850 | 1.691 | 0.225 | 13.3 | 84.3 |
1.532 | ||||||
60 minutes | 1.379 | 1.288 | 0.129 | 10.0 | 62.5 | |
1.197 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria
- Conclusions:
- In this study and under the experimental conditions reported the test item was considered to be non-corrosive to the skin.
- Executive summary:
Introduction
The purpose of this test was 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. Viable cells are able to reduce MTT to formazan whereas non-viable cells cannot. The results are used to make a prediction of the corrosivity potential of the test item (increased cytotoxicity is indicative of corrosion potential).
Methods
Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. 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 of 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 570 nm (OD570).
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:
Negative control
3 minutes - 100%*
60 minutes - 100%*
* The mean viability of the negative control tissues is set at 100%
Positive control
3 minutes - 3.3%
60 minutes - 2.9%
Test item
3 minutes - 84.3%
60 minutes - 62.5%
Acceptance criteria: The criteria required for acceptance of results in the test were satisfied.
Conclusion
In this study and under the experimental conditions reported: The test item was considered to be non-corrosive to the skin.
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