Registration Dossier
Registration Dossier
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EC number: 807-789-8 | CAS number: 111062-42-1
- 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

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study Initiation date: 04 April 18 Study conclusion date: 17 May 18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- 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:
- 2017
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octan-1-ol, reaction products with diphosphorus pentaoxide, potassium salts
- EC Number:
- 807-789-8
- Cas Number:
- 111062-42-1
- Molecular formula:
- C8-H18-O.K.O5-P2
- IUPAC Name:
- Octan-1-ol, reaction products with diphosphorus pentaoxide, potassium salts
1
- Specific details on test material used for the study:
- Test Item name: Agent 447C
Purity- 40% Active in Water, ~90% purity of active material
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- TEST ITEM:
EpiOcular™ (OCL-200) Reconstructed Human Ocular Epithelium
Lot # 27036
Keratinocyte Strain 4F1188
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 20 μI of PBS (sterile Dulbecco's Phosphate Buffered Saline) + 50 μI of test item
- Duration of treatment / exposure:
- 30 minutes ± 2 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours ± 15 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Details of materials, reagents and equipment used are recorded in the study data.
Positive control -Methyl Acetate
Negative control - Sterile Water (tissue grade)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- 0.061
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Remarks:
- Mean of viability
- Value:
- 2.838
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Prior to the study, the required preliminary test confirmed that the test item did not interfere with MTT or solvent.
% of viability: 2.838 - Classification = No prediction.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test determined that a 40% solution of the registered substance reduced the viability to below 60% and therefore “no prediction” regarding the irritation or corrosive potential of the substance can be determined according to OECD 492. OECD 492 cannot resolve between UN GHS Categories 1 and 2, further information on eye corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the eye. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 492, the registered substance is a Eye Irritant Category 2.
- Executive summary:
The eye irritation potential of Agent 447C (a 40% solution of the registered substance) was assessed in vitro according to OECD 492. After 30 ± 2 minutes exposure on the surface of the EpiOcular reconstructed ocular epithelium, and a 2 hour ± 15 minutes post-incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 2.838% and no prediction can be made for Agent 447C (a 40% solution of the registered substance) as further information is required to distinguish between corrosive and irritating.
In vitro testing with OECD 492 has not allowed for a prediction of eye irritation of Agent 447C (a 40% solution of the registered substance). As OECD 492 cannot resolve between UN GHS Categories 1 and 2, further information on eye corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the eye. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the “no prediction” result with OECD 492, the registered substance is a Eye Irritant Category 2.
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