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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
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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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to: OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, 11 December 2009, Vers. 4
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, 11 December 2009, Vers. 4
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiSkin
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 µL
- Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: Mean rel. MTT absorbance
- Run / experiment:
- 15 min treatment
- Value:
- 104.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100.0
- Positive controls validity:
- valid
- Remarks:
- 9.5
- Other effects / acceptance of results:
- After treatment with the test item Sa 57 the mean relative absorbance value did not decrease (104.3%) compared to the negative control. Therefore, the test item is not considered to possess an irritant potential.
Any other information on results incl. tables
Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.
Table 1: Results after treatment with Sa 57
Dose group |
Treat-ment Interval |
Absorbance 570 nm |
Absorbance 570 nm |
Absorbance 570 nm |
Mean Absorbance of 3 Tissues |
Standard Deviation of 3 Tissues |
Rel. Absorbance [% of Negative Control]** |
Standard Deviation [%] |
Negative Control |
15 min |
0.857 |
0.936 |
0.896 |
0.896 |
0.039 |
100.0 |
4.4 |
Positive Control |
15 min |
0.061 |
0.087 |
0.107 |
0.085 |
0.023 |
9.5 |
2.6 |
Sa 57 |
15 min |
0.988 |
0.902 |
0.916 |
0.935 |
0.046 |
104.3 |
5.1 |
* Mean
of two replicate wells after blank correction
** relative
absorbance [rounded values]:
After treatment with the test item Sa 57 the mean relative absorbance value did not decreas (104.3%) compared to the negative control. This value is well above the threshold for irritancy of ≤50%. Therefore, the test item is not considered to possess an irritant potential.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Sa 57 is not irritant to skin.
- Executive summary:
This in vitro study was performed to assess the irritation potential of Sa 57 by means of the Human Skin Model Test.
Three tissues of the human skin modelEpiSkin™ were treated with the test item, the negative or the positive control for 15 minutes.
Approximately 10 µL of the neat test item were applied to each tissue and spread to match the tissue size.
10 µL of either the negative control (deionised water) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue.
After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD 0.6 and ≤ 1.5 for the15 minutes treatment interval thus showing the quality of the tissues and the specific batch of the tissue model.
Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 9.5% thus ensuring the validity of the test system.
The standard deviations between the % variabilities of the test item, the positive and negative controls were below 18% thus ensuring the validity of the study.
The control values are well in the range of our historical data.
After treatment with the test item Sa 57 the mean relative absorbance value did not decrease (104.3%) compared to the negative control. Therefore, the test item is not considered to possess an irritant potential.
According to the current prediction model no classification and labeling of Sa 57 is necessary with respect to skin irritation under EU and UN classification.
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.
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