Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 256-425-9 | CAS number: 49673-81-6
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 3 to 6, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2010
- GLP compliance:
- no
- Remarks:
- the available study was originally run not for REACH purposes; however, it is scientifically valid and well documented.
Test material
- Reference substance name:
- L-lysine, S-carboxymethyl-L-cysteine salt
- IUPAC Name:
- L-lysine, S-carboxymethyl-L-cysteine salt
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- A reconstructed artificial human skin model comprising normal human epidermal keratinocytes, growing as an integrated three-dimensional cell culture model, perfectly mimicking the human skin in vitro. The model exhibits normal barrier functions (presence of a differentiated stratum corneum). It was provided by SkinEthic.
The sample has been tested as that, undiluted. The positive control SLS has been dissolved at 5 % in water. Phosphate buffer alone has been used as negative control.
16 mg of the product have been applied on each epidermis unit in three replicas. The exposition has been carried out for 42‘ at room temperature. At the end of the exposure period the product was removed and the tissue was incubated at 37 °C, 5 % CO2 for 42 hours. At the end of the exposure the MTT assay was performed to evaluate the cell survival on the skin units.
The MTT assay is simple, accurate and yields reproducible results. The key component is (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl tetrazolium bromide) or MTT (Sigma M-2128). This product is of yellowish colour in solution. Mitochondrial dehydrogenases of viable cells cleave the tetrazolium ring, leading to the formation of purple crystals which are insoluble in aqueous solutions. The crystals are re-dissolved in acidified isopropanol and the resulting purple solution is measured spectrophotometrically. An increase or decrease in cell number results in a concomitant change in the amount of formazan formed, indicating the degree of cytotoxicity caused by the test material.
After 42-hour incubation of epidermis, the tissues is incubated for 3 h in 300 μl/well in a 24 well plate of 1mg/ml MTT solution at 37 °C. The solution is than removed and replaced with 1500 μl/well of isopropanol, with further 2 h incubation at room temperature under medium speed shaking.
The absorbance at 550 nm is measured with a microplate reader (Tecan modello Sunrise remote). The absorbance values are corrected by subtracting the reading of the blanks, with the diluent only.
The results are expressed in terms of viability:
% of cell viability = [OD(550 nm ) test product / mean OD(550 nm) negative control] × 100
Acceptance criteria of method
- for negative control (CN): the mean OD value of the 3 tissue has to be ≥ 1.2, the standard deviation has to be ≤ 18 %
- for positive control (CP): the viability mean (expressed as % of the NC) has to be < 40 %, the standard deviation has to be ≤ 18 %
- for the sample: the standard deviation has to be ≤ 18 %
Criteria for in vitro interpretation Classification
Mean tissue viability ≤ 50 % classified
Mean tissue viability > 50% not classified - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 16 mg, undiluted - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- average of 3 replicates
- Value:
- 108.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Sample % mean cell viability (ds) after 42’ treatment and 42 h incubation Comment
test substance 108.9 (±8.5) not irritant
SLS 5 % 1.5 (±0.6) irritant
negative control (CN) 100 (±8.7) not irritant
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritant according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant to the skin.
- Executive summary:
Method
OECD 439. In vitro assay using a reconstructed artificial human skin model of normal human epidermal keratinocytes. Test sample was applied on 3 epidermis units for 42 minutes at room T. Then, the substance was removed and each tissue was incubated for 42 h at 37 °C and 5 % CO2. After incubation, evaluation of survival was done using the MTT assay and measuring absorbance at 550 nm. Based on absorbance values, a % of cell viability was derived.
Phosphate buffer was used as negative control; 5 % solution in water of SLS was used as positive control.
Results
Negative and positive controls were both valid. The mean cell viability of test substance was 108.9 ± 8.5 %, thus above the threshold of 50 %. Accordingly, the substance was considered as not irritant to the skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.