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Diss Factsheets
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EC number: 943-065-9 | 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
Endpoint summary
Administrative data
Description of key information
This studies relevant for these endpoints were performed according to GLP and the methods applied were fully compliant with OECD TG 437 and 439. The test material was not irritating to skin and not irritating to eye in vitro.
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:
- 2015-11-23 to 2015-12-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: Skinethic skin irritation test -42bis Standard operating procedure (SOP) 2009
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Justification for test system used:
- standard model
- Vehicle:
- water
- Details on test system:
- CELL CULTURE
- Supplier: SkinEthic Laboratories (Lyon, France).
- Source: adult human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation - Control samples:
- yes, concurrent negative control
- yes, concurrent vehicle
- Amount/concentration applied:
- 16 mg test material per tissue spread with 10 µL deionized water to matching tissue size
- Duration of treatment / exposure:
- 42 min
- Duration of post-treatment incubation (if applicable):
- n.a.
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- other: other: other: Optical Density, absorbance (570 nm
- Value:
- 1.947
- Remarks on result:
- other:
- Remarks:
- Time point: 42 min. Max. score: 2.054. Remarks: mean of 3 values (2,054, 1.893, 1.895). (migrated information)
- Irritation / corrosion parameter:
- other: other: Mean relative viability in %
- Value:
- 93.92
- Remarks on result:
- other:
- Remarks:
- Time point: 42 min. (migrated information)
- Other effects / acceptance of results:
- Optical density (as a marker of cell viability) of test item is comparable to value of the negative control. The test is to be considered as valid because:
a) optical density of negative control (mean value: 2.074+/-2.9%) > 0.8 and < 3.0 and standarad deviation <= 18%. Historical mean= 1.423
b) relative cell viability of the positive control (mean value: 1.10; standard deviation 2.22%) < 3.42% and standard deviation <= 18%
c) standard deviation of test item < 18% - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was not irritating in this in vitro assay.
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was negative in this assay.
Reference
Group | Time / [min] | Mean OD | Mean Relative viability / [%] |
Negative Control | 42 | 2.074 | 100 |
Positive Control | 42 | 0.023 |
1.10 |
Test Material |
42 |
1.947 |
93.92 |
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:
- 2015-11-20 to 2015-11-27
- 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)
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- 750 µL (i.e. 150mg/750µL) of test item, negative or positive control
- Duration of treatment / exposure:
- 240 minutes
- Number of animals or in vitro replicates:
- in vitro: triplicate design
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- run 1
- Value:
- 113.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- run 1
- Value:
- 62.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Run / experiment:
- run 1
- Value:
- 3.45
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the given experimental conditions the test material the test material has ocular corrosive potential.
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. The test material was corrosive in this in vitro assay.
Reference
Opacity |
Permeability |
IVIS |
||||
per cornea |
per group (mean value) |
SD |
||||
Negative Control |
0.9 % NaCl Solution |
-0.062 |
-0.001 |
-0.082 |
0.8 |
0.9 |
1.816 |
-0.001 | 1.801 |
||||
0.706 |
-0.001 | 0.696 |
||||
Positive Control |
20 % Imidazole solution |
70.793 |
2.142 |
102.928 |
106.6 |
4.1 |
71.315 |
2.303 |
105.860 |
||||
79.270 |
2.119 |
111.060 |
||||
Test material |
Art. 132039 |
66.507 |
3.447 |
118.217 |
113.9 |
16.4 |
72.337 |
3.699 |
127.827 |
||||
47.660 |
3.206 |
95.780 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No effects have been observed in in vitro assays as outlined above.
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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