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EC number: 846-768-8 | CAS number: 1450933-43-3
- 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
Irritation corrosion was studied in vitro in GLP compliant OECD 439 and OECD 492 assays. Both assays were negative.
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:
- November 22, 2016 - January 25, 2017
- 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)
- Version / remarks:
- July 26, 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Council Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006. B.40.bis. In vitro skin corrosion: human skin model test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Justification for test system used:
- standard model
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- No vehicle used in this study; The test item was applied neat to the tissues.
- Details on test system:
- CELL CULTURE
- Supplier: EpiSkin/SkinEthic Laboratories, Lyon, France)
- Source: human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation
- Format: 24 well plate
- Batch: 16-RHE-127
- Expires: Dec 12, 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment: room temperature
- Temperature of post-treatment incubation: 37°C
REMOVAL OF THE TEST MATERIAL AND CONTROL
At the end of the exposure periods, the test item, positive and negative control was removed immediately by gently rinsing with a minimum volume of 20 mL DPBS using a pipette. Excess DPBS was removed by gently shaking the tissue inserts and blotting the bottom of the tissue inserts with blotting paper. - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg ± 3 mg of solid test material
- Concentration (if solution): n/a
VEHICLE
- Amount(s) applied (volume or weight with unit): n/a
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity: n/a
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 40 µL ± 3 µl (deionised water )
- Concentration (if solution): n/a
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 40 µL ± 3 µl
- Concentration (if solution): A dodecyl sulfate sodium salt solution dissolved deionised water pure was used as positive control. - Duration of treatment / exposure:
- 42 min
- Number of replicates:
- 3
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 16 mg
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean relative viability in %
- Value:
- 103.48
- Vehicle controls validity:
- not applicable
- Remarks:
- The test item was applied neat to the tissues
- 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
- Direct-MTT reduction: none
- Colour interference with MTT: none
ACCEPTANCE OF RESULTS:
-Acceptability of the Quality Control Data of the Skin Model with Reference to Historical Batch Data:
The negative control OD values were 1.820, 1.782 and 1.842 and, thus, in the range of ≥0.8 and ≤3.0.
-Acceptability of the Positive and Negative Control:
After treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) the mean viability value was 1.53% (standard deviation: 8.38%) and, thus, lower than the historically established threshold of 3.10%. After treatment with the negative control (DPBS-buffer) the mean OD was 1.814 (standard deviation: 1.67%) and, thus, higher than the historically established threshold of 1.442.
-Test Substance Data Acceptance Criteria:
The standard deviation between the three tissues replicates treated with the test item was 0.76% and, thus, ≤18%.
The standard deviations between the three tissue replicates of the negative control and the positive control were 1.67% and 8.38%, respectively, and, thus, ≤18%.
The study met all acceptance criteria. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Non-corrosive
- Conclusions:
- This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. Under the conditions of the present study, the test item is not considered to be irritant to skin.
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439.Under the conditions of the present study, the test item is not considered to be irritant to skin.
Reference
Group | Time / [min] | Mean OD | Mean Relative viability / [%] |
Negative Control | 42 | 1.814 | 100.00 |
Positive Control |
42 |
0.028 |
1.53 |
Test Material | 42 | 1.877 | 103.48 |
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:
- Jul 30 - Sep 09, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- October 9, 2017
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: DB-ALM Protocol No. 164: Ocular Irritation Assay for Chemicals using EpiOcular™ EIT,
- Version / remarks:
- September 14, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EpiOcular Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irritation of chemicals; For use with MatTek Corporation`s Reconstructed Human EpiOcular Model; MatTek Corporation
- Version / remarks:
- June 29, 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Before application, the test item was pre-warmed to 37°C to get a liquid, which was applied neat to the tissues.. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL: 50 µL per tissue
NEGATIVE / VEHICLE CONTROL: 50 µL per tissue
Sterile deionized water was used as negative control.
POSITIVE CONTROL: 50 µL per tissue
Designation: Methyl acetate
Supplier: Merck KGaA
Lot-No.: S7451611
Catalog #: 8.09711
Purity (GC): 99.6%
Appearance: Liquid
Expiration date: June 30, 2022
Storage: 15 to 25°C - Duration of treatment / exposure:
- 30 ± 2 minutes
- Number of animals or in vitro replicates:
- in vitro: duplicate design
- Irritation parameter:
- other: Viability %
- Run / experiment:
- Run 1 / Experiment 1
- Value:
- 76.2
- 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: No observations
ACCEPTANCE OF RESULTS:
1. The negative control OD is >0.8 and <2.5 (2.086 and 2.183).
2. The mean relative viability of the positive control is below 50% of the negative control viability (13.1%).
3. The difference of viability between the two relating tissues of a single chemical is <20% (values between 0.6% to 6.3%) in the same run (for positive and negative control tissues and tissues of single chemicals).
The study met all acceptance criteria - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, the test item did not show an eye hazard potential. The test item is identified as not requiring classification and labeling according to UN GHS (No Category).
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 492. Under the conditions of the present study, the test item did not show an eye hazard potential. The test item is identified as not requiring classification and labeling according to UN GHS (No Category).
Reference
Mean OD | Mean Viability | |
Negative Control | 2.135 | 100.0% |
Positive Control | 0.280 | 13.1% |
Test Item | 1.626 | 76.2% |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.
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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