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EC number: 939-526-9 | CAS number: 90506-73-3
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation
In a study conducted following the OECD 439 Guideline determination of in vitro skin irritation using Reconstructed Human Epidermis, the test material was determined to be non-irritating.
Eye irritation:
A study was performed to assess the ocular irritancy potential of the test materials to the isolated bovine cornea. The test material was considered not to be an ocular corrosive or severe irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May - July 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Controls:
- not required
- Duration of treatment / exposure:
- 15 minutes
- Observation period:
- Post exposure incubation period of 42 hours.
- Number of animals:
- Not applicable
- Details on study design:
- Negative control:
Dulbecco's phosphate buffered saline (DPBS) with Ca++ and Mg++ was used as the negative control.
Positive control:
Sodium dodecyl sulphate (SDS) 5% w/v was used as the positive control.
Pre-test - Assessment of direct test material reduction of MTT:
MTT dye metabolism, cell viability assay; one limitation is possible interference of the test material with MTT. The test material may directly reduce MT, thus mimicking dehydrogenase activity. The property of the test material is only a problem, if at the time of the MTT there are still sufficient amounts of the test material present on or in the tissues. In this case, the true metabolic MTT reduction and the false direct MTT reduction can be differentiated and qualified.
To identify this possible interference each test material is checked for the ability to directly reduce MTT according to the following procedure:
10 mg of material added to 2 ml of a 0.3 mg/ml MTT solution prepared in assay medium. Solution is incubated in the dark at 37ºCm 5% CO2 in air for 3 hours, Untreated MTT used as a control. The test material did not directly reduce MTT, the MTT solution containing the test material did not turn blue to indicate the result.
Pre-incubation:
2ml of medium warmed to 37ºC and piped into the first three columns of a pre-labelled 12 well plate. A different 12-well plate was used for the test material and each control, incubated at 37ºC, 5% CO2 in air overnight.
Main Test:
(Day 1): Application of test material
Triplicate tissues were treated with the test material for an exposure period of 15 minutes, 10 mg of the material topically applied to the corresponding tissues ensuring a uniform covering. The epidermis surface first being moistened with 5 ul of sterile distilled water to improve contact between the solid test material and the epidermis. Triplicate tissues treated with 10 ul of negative control and 10 ul of SDS 5% w/v serving as the positive control. For the positive control care was taken to endure contact of the dilution and the epidermis surface, after 7 minutes contact time the SDS solution was re-spread with the SDS solution to maintain distribution for the remainder of the contact period, The plate(s) were kept in the biological safety cabinet at room temperature for 15 minutes. Removal of the material involved removing each tissue from the well and rinsing with a constant stream of DPBS for a period of 40 seconds. The rinsed tissues were transferred to the second column of 3 wells containing 2ml of maintenance medium, the rinsed tissues incubated at 37ºC, 5% CO2 in air for 42 hours.
(Day 3) MTT loading/Formazan Extraction:
Following 42 hours post-exposure period each 12-well plate was placed on a shaker for 15 minutes, 1.6 ml of the maintenance medium from beneath each tissue was transferred to a micro-tube and stored in a freezer at -14ºC to -30ºC to determine inflammatory mediator determination.
2ml of a 0.3 mg/ml MTT solution pipetted into the third column of three wells and tissues were transferred to the MTT filled wells, being careful to remove any excess maintenance medium. Tissues were incubated for 3 hours at 37ºC, 5% CO2 in air. A total biopsy was made using the EPISKIN biopsy punch. The epidermis was carefully separated from the collagen matrix using forceps containing 500 ul of acidified isopropanol. The tissues were then refrigerated at 1 to 10ºC until Day 6.
(Day 6) - Absorbance /optical density measurements:
Optical density measured at 540 nm using an Anthos 2001 microplate reader. - Irritation / corrosion parameter:
- % tissue viability
- Value:
- 107.6
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Classification of irritation potential is based upon relative mean tissue viability following the 15-minute exposure period followed by the 42 hour post-exposure incubation period according to the following:
Criteria for in vitro interpretation
Relative Mean Tissue Viability is =50% - classification is Irritant (I) R38
Relative Mean Tissue Viability is =50% - classification is Non-irritant (NI) - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a study conducted following the OECD 439 Guideline determination of in vitro skin irritation using Reconstructed Human Epidermis, the test material was determind to be non-irritating.
- Executive summary:
The results were evaluated according to EU labelling regulations Commission Directive 2001/59/EC for classification and labelling of dangerous items.
The acceptance criteria was achieved for the positive and negative controls.
Positive Control
The assay establishes acceptance criterion for an acceptable test if the relative mean tissue viability for the postive control treated tissues was =40% relative to the negative control treated tissues, and the standard deviation values of the percentage viability is =18%.
Negative Control
The assay establishes the acceptance criterion for an acceptable test if the mean OD540 for the negative control treated tissues was 0.6=, and the standard deviation value of the percentage viability is =18%.
Reference
The results were evaluated according to EU labelling regulations Commission Directive 2001/59/EC for classification and labelling of dangerous items.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 April 2013 to 14 September 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- cattle
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Neat
- Duration of post- treatment incubation (in vitro):
- 240 minutes
- Number of animals or in vitro replicates:
- not applicable
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 22.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- A study was performed to assess the ocular irritancy potential of the test materials to the isolated bovine cornea. The test material was considered not to be an ocular corrosive or severe irritant.
- Executive summary:
The test material was considered not to be an ocular corrosive or severe irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
In vitro data is available, conducted to OECD Guideline and under
GLP conditions.
Justification for selection of eye irritation endpoint:
In an in vitro eye irritation study using the corneal epithelium,
the test material is non- irritating.
Justification for classification or non-classification
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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