Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 938-105-7 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test) (2004)
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- other: Assessment of corrosive potential of the test substance by determination of its cytotoxic effect on an in vitro reconstructed human epidermis (exposure 3 min./rt and 60 min./37 °C, subsequently MTT).
- Details on test animals or test system and environmental conditions:
- The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany). Inserts were of 0.6 cm² size. The model has a functional stratum corneum with an underlying layer of living cells. The barrier function of the stratum corneum is adequate, as has been shown by the supplier.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: as negative control: physiological saline solution (0.9 % NaCl, 50 µL)
- Amount / concentration applied:
- 50 µl per insert
- Duration of treatment / exposure:
- 3 min./room temperature or 60 min. in an incubator (37 °C, 5 % CO2, maximum humidity)
- Observation period:
- post-exposure incubation: none
- Details on study design:
- The corrosive potential of the test item is assessed by determination of its cytotoxic effect on an in vitro reconstructed human epidermis. The test principle is based on the MTT assay reflecting the cell viability after exposure of the epidermal equivalent to topically applied test item.
All tests were performed in triplets for each time point. The test item was applied at a 100 % concentration, i.e. 50 µl per insert, for 3 min. (room temperature) or 60 min. (37 +/- 2 °C, 5 % CO2, maximum humidity). Cell viability was measured by the amount of MTT reduction, i.e. an OD value following exposure to the negative control substance or the test item.
Results and discussion
Any other information on results incl. tables
Substances are classified as „corrosive (R34)“, if the cell viability of the EST 1000 is decreased by more than 50 % after 3 min. of incubation to the test item, or if the cell viability is less than 15 % after 60 min. of exposure to the test item.
Sample No. |
Test item |
Time [min.] |
% Viability |
1-3 |
control NaCl 0.9 % |
60 |
100.00 |
7-9 |
test item |
60 |
98.19 |
13-15 |
control NaCl 0.9 % |
3 |
100.00 |
19-21 |
test item |
3 |
108.50 |
The test item was characterized by no significant impact on cell viability after 3 min. or after the 60 min. period.
Applicant's summary and conclusion
- Interpretation of results:
- other: no corrosive property
- Executive summary:
An in vitro according to OECD TG 431, for predicting non specific, corrosive potential of substances was conducted . Undiluted test item was applied topically on a reconstructed human skin (50 µl per insert; EST-1000, CellSystems, Germany). After an exposure period of 3 minutes at room temperature or 60 minutes in an incubator (37 °C, 5 % CO2, maximum humidity), the cell viability was 109 % and 98 %, respectively, as measured by a MTT conversion assay. It is therefore concluded that the test substance is not corrosive 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.
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