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EC number: 466-380-9 | CAS number: 52350-17-1
- 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:
- 15 Nov-21 Nov 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Commission Regulation (EC) No. 761/2009, adopted 23 July 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, London, England
Test material
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The reconstructed human epidermis model showed evidence of being a reliable and relevant stand-alone test for predicting rabbit skin irritation being used as a replacement for the Draize Skin irritation test. Test items are applied topically as the dermal route is the most likely exposure route and the results of the study are believed to be of value in predicting the likely skin irritancy potential to man.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: The EpiSkin™ model
- Tissue batch number(s): 16-EKIN-046
- Delivery date: 15 Nov 2016
- Date of initiation of testing: 15 Nov 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment/exposure: 37 °C
- Temperature of post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: All tissues were rinsed repeatedly with DPBS with Ca++ and Mg++ for approximately 40 seconds after the exposure period.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 h
- Spectrophotometer: Anthos 2001 microplate reader
- Wavelength: 562 nm
- Filter: no reference filter was used
- Linear OD range of spectrophotometer: no data
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues/killed tissues: killed tissues
- Procedure used to prepare the killed tissues: incubating in distilled water at 37 °C for 48 h
- N. of replicates: 3
- Method of calculation used: direct comparison of treated to untreated water-killed tissues
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: one
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be non-corrosive to skin if the viability after 15 minutes exposure period to the test substance followed by 42 hours post-exposure incubation is greater than or equal to 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 10 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): DPBS, 10 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): SDS, 10 µL
- Concentration (if solution): 5% (w/v) - 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:
- % tissue viability
- Run / experiment:
- 15-min exposure followed by 42-hour post-exposure incubation period
- Value:
- 113.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 11.1%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: An assessment found the test item was able to directly reduce MTT. The results of the procedure showed that no interference due to direct reduction of MTT occurred. It was therefore considered unnecessary to use the results of the water-killed tissues for quantitative correction of results or for reporting purposes.
- Colour interference with MTT: An assessment found the test item had the potential to cause colour interference with the MTT endpoint. The results of the procedure showed that no colour interference occurred. It was therefore considered unnecessary to use the results of the colour correction tissues for quantitative correction of results or for reporting purposes.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD562 for the negative control treated tissues was 0.844 and the standard deviation value of the viability was 14.2%. The negative control acceptance criteria was therefore satisfied.
- Acceptance criteria met for positive control: The relative mean tissue viability for the positive control treated tissues was 11.1% relative to the negative control treated tissues and the standard deviation value of the viability was 1.5%. The positive control acceptance criteria was therefore satisfied.
- Acceptance criteria met for variability between replicate measurements: The relative mean tissue viability for the test item treated tissues was 113.5% after a 15-minute exposure period and 42-hour post-exposure incubation period. The standard deviation calculated from individual tissue viabilities of the three identically test item treated tissues was 13.6%. The test item acceptance criteria was therefore satisfied.
Any other information on results incl. tables
Mean OD562 Values and Viabilities for the Negative Control, Positive Control, and Test Items
Item |
OD562 of tissues |
Mean OD562 of triplicate tissues |
± SD of OD562 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative control item |
0.839 |
0.844 |
0.120 |
99.4 |
100* |
14.2 |
0.966 |
114.5 |
|||||
0.727 |
86.1 |
|||||
Positive control item |
0.090 |
0.094 |
0.013 |
10.7 |
11.1 |
1.5 |
0.109 |
12.9 |
|||||
0.084 |
10.0 |
|||||
Test item |
0.906 |
0.958 |
0.115 |
107.3 |
113.5 |
13.6 |
1.090 |
129.1 |
|||||
0.879 |
104.1 |
* = The mean viability of the negative control tissues is set at 100%
OD = Optical density
SD = Standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- EU CLP: Not classified for Irritation
UN GHS: Not classified for Irritation (Category 3: cannot be determined) - Executive summary:
The skin irritation potential of the undissolved test item was assessed in accordance with OECD Guidance 439. Triplicate tissues were exposed to the test item for ≥ 15 minutes. At the end of the exposure period the test item was rinsed and the tissues incubated for a further 42 h in the presence of maintenance solution. Each tissue was then loaded with MTT for 3 h and any resultant colour extracted. After incubation and extraction, the solutions were aliquoted for absorbance measurements. Absorbency at 562 nm for each well was measured using a spectrophotometer. The test item did not cause interference in interpretation of the MTT colourmetric assy. Mean viability of tissues exposed to the test substance after 60 minutes were > 100 %. The quality criteria required for acceptance of the results were met. Under the conditions of this study the test substance is considered not to be irritant to the skin in accordance with EU CLP regulation.
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.
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