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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Remarks:
- opacity & permeability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 January 2018 to 07 March 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
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: No. 437, “Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals not requiring Classification for Eye Irritation or Serious Eye Damage”, adopted on 9th October 2017
- Version / remarks:
- 9th October 2017
- 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
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Slaughter House
- Age at study initiation: 3.5 to 4.5 years
Test system
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 Hours
- Number of animals or in vitro replicates:
- Triplicates
- Details on study design:
QUALITY CHECK OF THE ISOLATED CORNEAS: Done
NUMBER OF REPLICATES: Triplicates
NEGATIVE CONTROL USED: Normal saline
POSITIVE CONTROL USED: Ethanol
APPLICATION DOSE AND EXPOSURE TIME : 750 µL & 10 mins
TREATMENT METHOD: [closed chamber]
POST-INCUBATION PERIOD: yes, duration: 2 hours
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 3 times
- POST-EXPOSURE INCUBATION: 2 hours
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Done
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of spectrophotometry] (OD490) : Done
- Others: histopathology
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
IVIS UN GHS
≤ 3 No Category
> 3; ≤ 55 No prediction can be made
> 55 Category 1
SELECTION AND PREPARATION OF CORNEAS
QUALITY CHECK OF THE ISOLATED CORNEAS
NUMBER OF REPLICATES
NEGATIVE CONTROL USED
SOLVENT CONTROL USED (if applicable)
POSITIVE CONTROL USED
APPLICATION DOSE AND EXPOSURE TIME
TREATMENT METHOD: [closed chamber / open chamber]
POST-INCUBATION PERIOD: yes/no. If YES please specify duration
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period:
- POST-EXPOSURE INCUBATION:
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [ spectrophotometry] (OD490)
- Others (e.g, pertinent visual observations, histopathology): (please specify)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean-Test item
- Value:
- 95
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean-Positive control
- Value:
- 116.4
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Range of historical values if different from the ones specified in the test guideline: No
In vivo
- Other effects:
- - Histopathological findings: Epithelium: Mild focal squamous cell coagulation
Stroma: Apparently normal
Endothelium: Apparently normal
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the results obtained in the Bovine Corneal Opacity Test, the test item induced an IVIS of 95.0 after 10 minutes of treatment. The results indicated an appreciable increase in both the endpoints “permeability” as well as “opacity”. As the test item resulted in IVIS >55, considered as severe irritant causing serious eye damage and classified as UN GHS category 1, and no further testing will be carried out.
- Executive summary:
Eyes of cattle were collected from slaughter house by immersing them in the Hank’s Balanced Salt Solution (HBSS) with antibiotics (penicillin and streptomycin) in a suitable container and transported to the test facility by placing on cool packs. Eye balls free of defects were selected for the experiment. Empty cornea holder’s opacity with pre-warmed Eagle’s Minimum Essential Medium was measured and the mean opacity value obtained was determined as I0.Cornea holders with selected Corneas were equilibrated at 32±1ºC for 1 hour with Eagle’s Minimum Essential Medium with 1% Fetal Bovine Serum supplemented with 1% antibiotics and baseline opacity was recorded for each cornea. Corneas with opacity units less than 7 were selected and used for the study and distributed for the treatment groups.Quantity of 750 µL of test item, normal saline (negative control) and ethanol (positive control) was introduced into anterior chamber in triplicates to the designated cornea holders and incubated at 32±1ºC for 10 minutes. Treated corneas were washed with EMEM with phenol red. Opacity was measured with the aid of opacitometer and permeability was determined spectrophotometrically at 490 nm (OD490) using 4 mg/mL sodium fluorescein, post incubation of 90 min at 32±1ºC. Baseline opacity and permeability values obtained for negative control (normal saline) treated corneas were used for correction.The mean corrected opacity and mean corrected permeability values of test item is 71.31 and 1.581 respectively. The in vitro Irritancy Score (IVIS) of test item resulted in 95.0 indicating corrosivity or severe irritancy to Bovine corneas.
Whereas the positive control resulted in the mean corrected opacity and mean corrected permeability values is 91.91 and 1.633 respectively. Thein vitroIrritancy Score (IVIS) of positive control resulted in 116.4, indicatingcorrosivity or severe irritancy to Bovine corneas.
In histopathological examination, the corneas treated with negative control did not show any abnormalities, whereas in thehistopathological examination ofthe corneas treated with test item resulted in mild focal squamous cell coagulation in epithilium. Stroma and endothelium of all corneas were apparently normal.
In positive control, histopathology data of epitheliumshowed mild diffuse and moderate multifocal cytoplasmic and nuclear vacuolization in the wing and basal layers.In stroma minimal multifocal expansion of the superficial collagen was observed. Endothelium was apparently normal in all three corneas.
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