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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-04-08 to 2014-04-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): XTA 823- Substance type: yellow slightly viscous liquid- Physical state: liquid- Analytical purity: substance is a UVCB (49.8%)- Lot/batch No.: BLW060113- Expiration date of the lot/batch: 2014-12-30- Stability under test conditions: no data- Storage condition of test material: at room temperature in the dark- other:- Production date: 2014-02-30
Constituent 1
In vitro test system
- Test system:
- human skin model
- 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)
Test animals
- Species:
- other: reconstructed human epidermis
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- EPISKIN(TM) Reconstructed Human Epidermis Model Kit- Source: SkinEthic Laboratories, Lyon, France- Date received: 2014-04-08- EpiSkin(TM) Tissues (0.38cm²) lot number: 14-EKIN-012- Maintenance Medium lot number: 14-MAIN3-014- Assay Medium lot number: 14-ESSC-013Pre-incubation (day 0: tissue arrival)- Before removal from the transport plate each tissue was inspected for any air bubbles between the agarose gel and the insert: tissues satisfactory: yes; temperature indicator color satisfactory: yes; agar medium color satisfactory: yes- 2 ml of maintenance medium, warmed to approximately 37°C, was pipetted into the 2 wells of the first column of a pre-labeled 12-well plate. Each epidermis unit was transferred into the maintenance medium filled wells (2 units per plate). A different 12-well plate was used for each test item, control and time point. The tissues were incubated at 37°C, 5% CO2 in air overnight.- After 24 hours the medium underneath the tissues was refreshed an the tissues were returned to the incubator for approximately 24 hours further.
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 50 µl - Concentration (if solution): used as supplied (undiluted)NEGATIVE CONTROL : 0.9% sodium chloride solution- Amount(s) applied (volume or weight with unit): 50 µl- Batch: 300999 104- Purity: 0.9%- Expiry date: 2015-01-01- Storage conditions: at room temperature- Concentration: used as suppliedPOSITIVE CONTROL: glacial acetic acid- Amount(s) applied (volume or weight with unit): 50 µl- Batch: 114957- Purity: >99.7%- Expiry date: 2014-11-08- Storage conditions: at room temperature- Concentration: used as supplied
- Duration of treatment / exposure:
- 240 minutes
- Observation period:
- 2 days
- Details on study design:
- PRE-TEST PROCEDURETest for direct MTT reduction (day 0)- 50 µl of the test item was added to 2.0 ml of a 0.3 mg/ml MTT solution freshly prepared in assay medium. The solution was incubated in the dark at 37°C, 5% CO2 in air for 3 hours. Untreated MTT solution was used as a control..MAIN STUDYApplication of test item and rinsing (day 1)- 2.0 ml of assay medium, warmed to approximately 37°C, was pipetted into 2 wells of the second and third columns of the 12-well plate. The tissues were transferred into the second column.- Duplicate tissues were treated with the test item for exposure periods of 3, 60 and 240 minutes. Duplicate tissues were treated with the positive and negative control items for an exposure period of 240 minutes. 50 µl of the test item was applied topically to the corresponding tissus ensuring uniform coverage of the tissues. Duplicate tissues, treated with 50 µl of 0.9% w/v sodium chloride solution, served as negative controls and duplicate tissues, treated with glacial acetic acid served as positive controls. - The treated tissues were kept in a biological safety cabinet at room temperature for the appropriate exposure period.- At the end of the exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing Dulbecco's phosphate buffered saline (PBS) with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of DPBS to gently remove any residual test item. Each rinsed tissue was placed into to the third column of the 12-well plate until all tissues were rinsed. - 2.0 ml of a 0.3 mg/ml MTT solution freshly prepared in assay medium, was pipetted into 2 wells of the fourth column of each 12-well plate. The tissues were transferred into the MTT filled wells. The tissues were incubated for approximately 3 hours at 37°C, 5% CO2 in air. At the end of the 3-hour incubation period each tissue was placed onto absorbent paper to dry. A total biopsy of the epidermis was taken using the EPISKIN(TM) biopsy punch. The epidermis was carefully separated from tje collagen matrix using forceps and both parts (epidermis and collagen matrix) were placed into labeled 1.5 ml micro tubes containing 500 µl of acidified isopropanol. Each tube was plugged, mixed thoroughly and stored overnight at room temperature, protected from light, to extract formazan crystals out of the MTT-loaded tissus.Asorbance/optical density measurements (day 2)- At the end of the formazan extraction period each tube was mixed thoroughly on a vortex mixer to produce a homogenous colored solution.- For each tissue, duplicate 200 µl samples were transferred to the appropriate wells of a pre-labeled 96-well plate. 200 µl of acidified isopropanol alone was added to the two wells designated as 'blanks'. The optical density was measured (quantitative viability analysis) at 562 nm (wihtout a reference filter) using the Anthos 2001 microplate reader.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- after 240 min exposure
- Value:
- 108.1
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- after 60 minutes exposure
- Value:
- 143.9
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- after 3 minutes exposure
- Value:
- 129.1
In vivo
- Other effects:
- Direct MTT reduction: the MTT solution containing the test item remained yellow. This was taken to indicate that the test item did not reduce MTT.
Any other information on results incl. tables
Quality criteria:
- The relative mean tissue viability for the positive control treated tissues was 3% relative to the negative control treated tissues following the 240-minute exposure period. The positive control acceptance criterion was therefore satisfied.
- The mean OD562 for the negative control treated tissues was 0.925. The negative control acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test item was classified as non-corrosive to the skin. The following classififcation criteria apply: -EU DSD (65/548/EEC): not classified for corrosivity -EU CLP (1272/2008/EC)/UN GHS: not classified for corrosivity-UN Packing Group: non-corrosive.
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies