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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 812-493-7 | CAS number: 1312943-49-9
- 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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 September 2009 - 28 December 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- OECD draft dated 20 March 2009
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 1st ATP Council Regulation No 440/2208, Council Regulation No 761/2009 of 23 July 2009
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: From adult donors; obtained from EpiSkinTM
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN
- Tissue batch number(s): Test No. 1: 09-EKIN-031; Test No. 2: 09-EKIN-045
- Production date: Not reported
- Shipping date: Not reported
- Delivery date: 09-EKIN-031 = 15th September 2009; 09-EKIN-045 = 22nd December 2009
- Date of initiation of testing: 15th September 2009 and 22nd December 2009 for test 1 and 2, respectively.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Not reported
- Temperature of post-treatment incubation (if applicable): Following exposure, the skin sample was places in MTT solution of 0.5 mg/mL concentration for 3 hours at 37°C.
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 3 x 0.5 mL of PBS (PanBiotech GmbH – Batch No 5000209)
- Observable damage in the tissue due to washing: None reported
- Modifications to validated SOP: None reported
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.5 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Not reported
- Wavelength: 570 nm
- Filter: None reported
- Filter bandwidth: Not applicable
- Linear OD range of spectrophotometer: Up to 400 pg/mL
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: In historic negative control data the viability is 86.1 – 113.1 %
- Barrier function: SDS used as a positive control, and the mean viability in historic control data is 2.9 - 23.9 %
- Morphology: Well-differentiated epidermis consisting of a basal layer, several spinous and granular layers and a thick stratum corneum
- Contamination: For both batches of the skin models used the absence of HIV1 and 2, hepatitis C antibodies and the absence of hepatitis B antigen in the donor blood has been confirmed. Additionally, the absence of bacteria, fungus and mycoplasma was verified on the epidermal cells.
- Reproducibility: For the EPISkin batch used in test 1; histology scoring (HES stained vertical paraffin sections. n = 6), specification > 19.5, result was 22.0 ± 0.3 , CV = 1.4 %, and for IC 50 determination (SDS concentration, MTT test, n - 14) specification ≥ 1.5 mg/mL; result was 1.8 mg/mL. For the EPISkin batch used in test 2; histology scoring (HES stained vertical paraffin sections. n = 6), specification > 19.5, result was 22.4 ± 0.4, CV = 1.7 %, and for IC 50 determination (SDS concentration, MTT test, n - 14) specification ≥ 1.5 mg/mL; result was 1.7 mg/mL.
NUMBER OF REPLICATE TISSUES: 3 per test item, negative and positive control
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues
- N. of replicates : 3
- Method of calculation used: Optical density
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be non-irritant to skin if the viability after 15 minutes of exposure and 42 hours of post-treatment incubation is >50% and the amount IL-1α release is ≤ 60 pg/mL - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg
VEHICLE:
- Amount(s) applied (volume or weight with unit): 5 µL
- Concentration (if solution): N.A.
- Lot/batch no. (if required): ADL PROCHILAB Batch No 100439801
- Purity:
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): Not reported
- Concentration (if solution): Not applicable
POSITIVE CONTROL
- Amount(s) applied (volume or weight): Not reported
- Concentration (if solution): 5 % SDS - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3 per test; 2 tests
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test 1; Tissue 7
- Value:
- 176.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test 1; Tissue 8
- Value:
- 154.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test 1; Tissue 9
- Value:
- 59.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test 1; mean
- Value:
- 130.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- other: IL1-α level (pg/mL)
- Run / experiment:
- Test 1; Mean
- Value:
- 6.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test 2; Tissue 7
- Value:
- 112.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test 2; Tissue 8
- Value:
- 98.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test 2 Tissue 9
- Value:
- 79.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test 2 Mean
- Value:
- 97
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- other: IL1-α level (pg/mL)
- Run / experiment:
- Test 2; mean
- Value:
- 3.9
- 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:
- - OTHER EFFECTS:
- Visible damage on test system: None reported
- Direct-MTT reduction: See tables 1 to 6.
- Colour interference with MTT: None reported
DEMONSTRATION OF TECHNICAL PROFICIENCY: Negative and positive control values were within the historic ranges
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, mean optical density of the three replicates was ≥ 0.153 (observed 0.250 and 0.384 in tests 1 and 2, respectively).
- Acceptance criteria met for positive control: Yes, mean viability was ≤ 40 % (observed; 12.2 and 10.0 % in tests 1 and 2, respectively.)
- Acceptance criteria met for variability between replicate measurements: Standard Deviation was ≤ 18 for the test item, positive and negative control replicates in Test 2 (observed; 16.3, 1.5 and 8.3, respectively). In test 1, the standard deviation was > 18 for the test item and negative control (observed; 62.5 and 44), therefore, test 2 was conducted to confirm the results obtained with test 1.
- Range of historical values if different from the ones specified in the test guideline: Historic values reported in tables 7 and 8.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin irritation potential of the test item was assessed in guideline human skin model tests and it was concluded that the test item did not meet the requirements for classification.
- Executive summary:
The skin irritation potential of the test item was investigated by topical administration on in vitro human reconstructed epidermis in a EU B.46 guideline study. The test item was applied to two Human skin model surfaces (Episkin), during 15 minutes followed by a 42 hours post-incubation period. The study was conducted in triplicate on two occasions with concurrent positive and negative controls. The cell viability was quantified by measurement of the cell succinate dehydrogenase activity. This enzyme was responsible for the MTT reduction into blue formazan crystal. The concentration of formazan was measured by determining the Optical Density (OD) at 570 nm. The absorbance was measured in triplicate of MTT extract. The measured absorbances are proportional to the number of live cells. Additionally, to confirm the results of the tests, the released IL1-α by the epidermis in the assay medium was measured (on frozen medium) using an ELISA test.
In test 1, the mean viability of the epidermis skins was 130.2% (considered as 100%), versus 12.2% in the positive control (5% SDS). To confirm these results, the IL1-α released by the epidermis was measured; the mean concentration measured was 6.8 pg/mL, versus 157.9 pg/mL in the positive control and 7.5 pg/mL in the negative control. Due to the high variability in the optical density obtained in the three epidermis treated in a same way in Test 1, a second experiment was conducted to confirm the non classification of the test item. The mean viability of the epidermis skins was 97.0%, versus 10.0% in the positive control. The mean concentration of ILl-α released was 3.9 pg/mL, versus 77.7 pg/mL in the positive control and 10.2 pg/mL in the negative control. Based on these results, the test item is not classified for skin irritation under UN GHS regulations.
The study is a GLP compliant guideline experiment study acceptable without restrictions for assessment of this endpoint.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Napriek tomu, že agentúra ECHA poskytuje online veľa materiálov vo vašom jazyku, časť tejto stránky je k dispozícii len v anglickom jazyku. Viac informácií o praxi v oblasti viacjazyčnosti v agentúre ECHA.
Internetová stránka agentúry ECHA Stránka nie je plne podporovaná v prehliadači Internet Explorer 7 (a starších verziách). Aktualizujte si prehliadač Internet Explorer na novšiu verziu.
Táto webová lokalita využíva súbory cookies, aby sme vám zabezpečili najlepšie používateľske prostredie na našich webových stránkach.
Viac informácií ako využívame súbory cookies.