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Diss Factsheets
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EC number: 947-922-8 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Dec 2017- 04 April 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of alcohols, C11-14-iso, C13 rich and phosphorus pentoxide
- EC Number:
- 947-922-8
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- Reaction products of alcohols, C11-14-iso, C13 rich and phosphorus pentoxide
- Test material form:
- liquid
- Details on test material:
- clear yellowish liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EPI-200-SIT
- Justification for test system used:
- Recommended in vitro model
- Details on test system:
- Dose Groups
1. Negative control 30 µL DPBS
2. Positive control 30 µL 5% SDS solution
3. Test Item 30 µL
The test was performed on a total of 3 tissues per dose group.
SDS sodium dodecyl sulfate
DPBS Dulbecco's phosphate buffered saline - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 µL Test item
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 47 hours
- Number of replicates:
- 3
Test system
- Details on study design:
- The test was performed on EpiSkin,a three-dimensional model of the human epidermis. 3 replicate tissues are dosed with the test
item, the negative control (30 µL DPBS) and the positive control (300µL 5% SDS), respectively. After 60 minutes treatment period at room temperature the test item and the controls are rinsed off with DPBS and the tissues are post-incubated for 47 h (based on RhE model). Then the tissues are stained via MTT for 3 hours. The MTT was extracted from the tissues for 2 hours at room temperature with gentle shaking on a plate shaker. MTT extracts are measured photometrically at 570 nm.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- negative control
- Value:
- >= 96.1 - < 102.6
- Negative controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- positive control
- Value:
- >= 4.7 - < 4.9
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test item
- Value:
- >= 7.2 - < 7.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on the results obtained under the laboratory testing conditions, the test item has been categorized as irritant to Reconstructed Human Epidermis (RhE) in accordance with UN GHS Category 2 or Category 1, as the mean percentage after 60 minutes of exposure and 45 hours and 10 minute post incubation, tissue viability was less than 50% of the negative control.
- Executive summary:
The skin irritation potential of the submission study was evaluated using Reconstructed Human Epidermal Model - EpiDerm (EPI-200 -SIT) according to OECD Guideline 439.
Based on the results obtained under the laboratory testing conditions, the test item has been categorized as irritant to Reconstructed Human Epidermis (RhE) in accordance with UN GHS Category 2 or Category 1, as the mean percentage after 60 minutes of exposure and 45 hours and 10 minute post incubation, tissue viability was less than 50% of the negative control.
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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