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Diss Factsheets
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EC number: 813-180-8 | CAS number: 5856-32-6
- 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:
- 21 Sep - 05 Oct 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Source strain:
- other: EpiDermTM; reconstructed three-dimensional human epidermis (EPI-200)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200 SIT kits, EpiDerm™ tissue, purchased from MatTek Corporation (Bratislava, Slovakia)
- Tissue batch number(s): 21697
- Delivery date: 29 Sep 2015
- Date of initiation of testing: 29 Sep 2015
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1.5 °C
- Temperature of post-treatment incubation (if applicable): 37 ± 1.5 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: tissue samples were rinsed with DPBS at least 15 times, then the tissues were carefully dried using sterile cotton tipped swabs and transferred to new plates
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: Versamax® Molecular Devices, Softmax Pro, version 4.7.1
- Filter: 570 ± 1 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD (540 - 570 nm) = 1.798 ± 0.070
- Barrier function: 6 h
- Contamination: No, sterile
NUMBER OF REPLICATE TISSUES: triplicates each in 3 independent tissues
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues:
Test item’s colour interference potential: The test substance was assessed for its potential to interfere with the MTT assay prior to the main test. The colour of test item/water mixture did not change during the incubation period compared with the colour of the pure test item. Therefore, the test item passed the colour interference test and an additional test with a viable tissue without MTT addition was not necessary.
Ability of the test item to directly reduce MTT: Since the colour did not turn blue/purple, the test item was not considered to be a MTT reducer, and an additional test with freeze-killed tissues was not necessary.
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the viability is less than or equal to 50%
- The test substance is considered to be non-irritant to skin if the viability is greater than 50% - Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 ± 2 mg (~ 39 mg/cm² according to guideline) of the solid test item were applied directly onto the EpiDerm™ tissue, after the surface had been wetted with 25 μL of DPBS, respectively.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL Dulbecco`s phosphate buffered saline was used as negative control in each independent tissue.
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL of a 5% sodium lauryl sulphate solution in deionised water was used a positive control in each independent tissue. - Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- triplicates each in 3 independent tissues
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- >= 94.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system:
- Direct-MTT reduction: No
- Colour interference with MTT: No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes (mean absorbance of the negative control = 1.660)
- Acceptance criteria met for positive control: Yes (mean absorbance of the positive control = 0.083)
- Acceptance criteria met for variability between replicate measurements: Yes
- Range of historical values if different from the ones specified in the test guideline: Data of 13 studies performed from Jul 2015 - Oct 2015
Positive Control:
Mean Viability: 4.77%; RSD: 14.9%; Range of Viabilities: 4.00 - 5.90%; Mean Absorption: 0.084; RSD: 16.6%; Range of Absorbance: 0.069 - 0.097
Negative Control:
Mean Absorption: 1.77; RSD: 8.55%; Range of Absorbance: 1.66 - 1.98
Any other information on results incl. tables
Table 1: Results after treatment with the test item and the controls
Dose Group |
Treatment |
Absorbance |
Absorbance |
Absorbance |
Mean |
Rel. Absorbance |
Relative |
Mean Rel. |
Negative |
60 min |
1.685 |
1.610 |
1.685 |
1.660 |
101.5 |
2.6 |
100.0 |
Positive |
60 min |
0.091 |
0.083 |
0.076 |
0.083 |
5.5 |
9.0 |
5.0 |
Test Item |
60 min |
1.575 |
1.531 |
1.607 |
1.571 |
94.9 |
2.4 |
94.6 |
* Mean of three replicate wells after blank correction
** Relative absorbance per tissue [rounded values]: 100 x (absorbance of tissue) / (mean absorbance negative control)
*** Relative absorbance per treatment group [rounded values]: (100 x mean absorbance (test item/positive control)) / (mean absorbance negative control)
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the RHE test method, the test substance did not show irritant properties.
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