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EC number: 242-604-9 | CAS number: 18824-74-3
- 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
The skin irritation study was positive and although viabilty was lower than the positive control sodium dodecyl sulphate, it was considered within the limits to conlude Skin Irrit 2
Although the Eye study performed was planned to assess the Eye Irrit 2 - Non-Classified boundary, the severity of the results suggest that Eye Dam 1 classification is appropriate.
For this assay, viablity of < 2% is a clear sign of Eye Dam 1 and normally, results in the 2 - 10% range are likely to be Eye Dam 1.
From expert assessment, Eye Dam 1 classification has been recommended.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study 2020
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch LP08112019
99% purity
White powder - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- Reconstructed human epidermal model
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- After pre-wetting tissues with 25µl Dulbecco’s Phosphate Buffered Saline a single, topical application of nominal 25mg neat test item to the surface of the EpiDermTM model
- Duration of treatment / exposure:
- 60±1 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, ≥95% Relative Humidity (RH))
- Duration of post-treatment incubation (if applicable):
- 42±4 hours post-treatment incubation, prior to the MTT endpoint
- Number of replicates:
- Three tissues per condition (n=3).
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- ca. 6.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- No other effects recorded
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Although viabilty was lower than the positive control sodium dodecyl sulphate, it was considered within the limits to conlude Skin Irrit 2
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study performed 2020
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch LP08112019
99% purity
White powder - Species:
- human
- Details on test animals or tissues and environmental conditions:
- Stratified human keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- After pre-wetting tissues with 20µl Dulbecco’s Phosphate Buffered Saline for 30 minutes ± 2 minutes, a single, topical application of approximately 50mg of neat test item was applied to the surface of the EpiOcularTM model
- Duration of treatment / exposure:
- 6 hours ± 15 minutes, followed by a 25 minutes ± 2 minutes post-treatment immersion, and 18 hours ± 15 minutes post-treatment incubation, prior to the MTT endpoint
- Number of animals or in vitro replicates:
- Three tissues per condition (n=3).
- Irritation parameter:
- other: Viabiilty index
- Run / experiment:
- 1
- Value:
- ca. 2.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- Viabilty range across three replicates prior to adjustment for colour control 2.5 - 3.4
No other observations - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Although the study performed was planned to assess the Eye Irrit 2 - Non-Classified boundary, the severity of the results suggest that Eye Dam 1 classification is appropriate.
For this assay, viablity of < 2% is a clear sign of Eye Dam 1 and normally, results in the 2 - 10% range are likely to be Eye Dam 1.
From expert assessment, Eye Dam 1 classification has been recommended.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
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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