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EC number: 230-908-4 | CAS number: 7365-82-4
- 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:
- 10 September 2018 - 13 September 2018
- 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:
- 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:
- 29. Jul. 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- 30. May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-(carbamoylmethyl)taurine
- EC Number:
- 230-908-4
- EC Name:
- N-(carbamoylmethyl)taurine
- Cas Number:
- 7365-82-4
- Molecular formula:
- C4H10N2O4S
- IUPAC Name:
- N-(carbamoylmethyl)taurine
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Batch no. GL865320171205
Appearance White crystalline powder
Composition 2-((2-Amino-2-oxoethyl)amino)ethanesulfonic acid
Purity ≥99% Assay (Titration)
Homogeneity homogeneous
Expiry date 5. Dec. 2019
Storage Room Temperature (20 ± 5 °C)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- As per the OECD Guidelines.
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Tissue 1 ( 3 min exposure): 26.7 mg
Tissue 2 ( 3 min exposure): 25.4 mg
Tissue 1 ( 1 h exposure): 25.9 mg
Tissue 2 ( 1 h exposure): 26.6 mg - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Duration of post-treatment incubation (if applicable):
- 3 hours at 37 ± 1°C and 5.0 ± 0.5% CO2
- Number of replicates:
- Triplicate wells for two sets of tissues.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of two tissues (3 min)
- Value:
- 85.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean ot two tissues (1 h)
- Value:
- 100.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The criterion for optical density of the negative control (≥ 0.8 and ≤ 2.8) was fulfilled: optical density was 1.6 (3 minutes) and 1.5 (1 hour). The positive control showed clear corrosive effects. The criterion for the viability of the 1 hour experiment, expressed as % of the negative control (< 15%), was fulfilled, too. The mean value of relative tissue viability was 9.3%. 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.
Any other information on results incl. tables
Mean Absorbance Values of the 3 Minutes Experiment
Designation | Negative Control | Substance | Positive Control |
Mean – blank (tissue 1) | 1.668 | 1.478 | 0.559 |
Mean – blank (tissue 2) | 1.630 | 1.343 | 0.492 |
Mean of the two tissues | 1.649 | 1.411 | 0.526 |
Relative standard deviation | 1.6% | 6.8% | 9.0% |
Mean Absorbance Values of the 1 h Experiment
Designation | Negative Control | Substance | Positive Control |
Mean – blank(tissue 1) | 1.576 | 1.563 | 0.134 |
Mean – blank (tissue 2) | 1.500 | 1.536 | 0.151 |
Mean of the two tissues | 1.538 | 1.550 | 0.143 |
Relative standard deviation | 3.5% | 1.2% | 8.6% |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is considered to be non-corrosive to skin based on a reliable in vitro skin corrosion study conducted according to OECD TG 431.
- Executive summary:
In an in vitro skin corrosion study conducted according to OECD TG 431, human skin tissue (epidermis keratinocytes) was exposed to undiluted substance for 3-minutes and 1-hour. The mean value of relative tissue viability of the substance was 85.5% after 3 minutes treatment. This value is above the threshold for corrosivity (50%). After 1-hour treatment, the mean value of relative tissue viability of the substance was 100.8%, which is above the threshold for corrosivity (15%). Therefore, the substance is considered as non-corrosive to skin.
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