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EC number: 500-295-0 | CAS number: 106233-09-4 1 - 2.5 moles ethoxylated
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. No analysis was carried out to determine the homogeneity, concentration or stability of the test item formulation as required by GLP regulation. This was justified in the GLP compliance statement.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The department of health of the government of the United Kingdom.
Test material
- Reference substance name:
- Alcohols, C16-18, ethoxylated, phosphates
- EC Number:
- 500-295-0
- EC Name:
- Alcohols, C16-18, ethoxylated, phosphates
- Cas Number:
- 106233-09-4
- Molecular formula:
- UVCB
- IUPAC Name:
- Alcohols, C16-18 (even numbered) ethoxylated, phosphates, mono- and diesters
- Details on test material:
- - Name of test material (as cited in study report): Trade name (CAS 106233-09-4)
- Substance type: UVCB
- Physical state: off white solid block
- Analytical purity: >95%
- Lot/batch No.: 533935
- Expiration date of the lot/batch: 2013-09-05
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST METHOD
The bovine corneal opacity and permeability (BCOP) test is an in-vitro test method used to classify substances as “ocular corrosives and severe irritants”. The potential of a test substance to cause ocular corrosivity or severe irritancy is measured by its ability to induce opacity and increased permeability in an isolated bovine cornea. The opacity and permeability assessments of the cornea are combined to derive an in-vitro irritancy score (IVIS), which is used to classify the irritancy level of the test substance.
IDENTIFICATION OF THE SOURCE OF THE EYES, STORAGE AND TRANSPORT CONDITIONS
- Source: Local abattoir (not further specified)
- Donor animals: freshly slaughtered cattle
- Date and time of eye collection: no data
- Time interval prior to initiating testing: the corneas were prepared immediately on arrival.
- Transport medium and temperature conditions: Hanks´ Balanced Salt Solution (HBSS) on ice with penicillin/streptomycin
PREPARATION OF THE EYES (BEFORE EXPOSURE)
- Eyes free of defects (scratches, neovascularisation): yes
- Dissection of the eyes and treatment: Corneas were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders.
- Description of the cornea holder: The cornea holders consist of an anterior and a posterior compartment, which interface with the epithelial and endothelial sides of the cornea.
- Test medium and temperature conditions used in the cornea holder: complete Minimum Essential Medium (MEM); prior to use: pre-warmed to 32 ± 1 °C
- Equilibration time: 1 h at 32 ± 1 °C
- Quality check of the equilibrated corneas: free of macroscopic defects
DETERMINATION OF THE INITIAL OPACITY
- Method: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
Test system
- Vehicle:
- physiological saline
- Controls:
- other: number of eyes for the negative control: 3; number of eyes for the positive control: 3
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: 20%
VEHICLE
- Substance: physiol. saline
- Concentration: Example: 0.9% NaCl solution in deionised water
POSITIVE SUBSTANCE
- Substance: imidazole
- Concentration: 20% imidazole solution in physiol. saline - Duration of treatment / exposure:
- 4 h at 32 ± 1 °C
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- 3 corneas were used
- Details on study design:
- TEST CONDITIONS
- Short description of the method used:
The MEM was removed from the anterior chamber of the BCOP holder and the test item preparation or control items were applied to the cornea. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea.
POST-EXPOSURE TREATMENT
- Removal of the test substance: The test substance was removed from the anterior chamber and the epithelium washed at least three times.
- Medium for washing the corneas: complete MEM containing phenol red
- Medium for final rinsing: complete MEM without phenol red
DETERMINATION OF THE FINAL OPACITY
- Method: Corneal opacity was determined via an opacitometer.
- Time of determination: After refilling fresh MEM without phenol red in the anterior chamber the final opacity was measured.
DETERMINATION OF THE CORNEAL PERMEABILITY:
- Method: Sodium fluorescein solution was added to the anterior chamber of the cornea holder while the posterior chamber was filled with fresh medium. The amount of sodium fluorescein that crosses into the posterior chamber was quantitatively measured via UV/VIS spectrophotometry at 492 nm recorded as optical density (OD492).
- Amount and concentration of the dye: 1 mL sodium fluorescein solution (5 mg/mL)
- Incubation time: no data
- Treatment for measuring: OD492 of a 360 µL aliquot was determined in a flat-bottomed 96-well plate. If the OD492 was greater than 1.500 a 1:5 dilution of the solution in complete MEM was performed.
HISTOPATHOLOGY
The corneas were retained after testing for possible conduct of histopathology. Each cornea was placed into a pre-labelled tissue cassette fitted with a histology sponge to protect the endothelial surface. The cassette was immersed in 10% neutral buffered formalin.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: IVIS
- Basis:
- other: mean out of all 3 eyes
- Time point:
- other: 4 h
- Score:
- 105.8
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance
- Irritation parameter:
- other: opacity
- Basis:
- other: mean out of all 3 eyes
- Time point:
- other: 4 h
- Score:
- 13
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance
- Irritation parameter:
- other: permeability
- Basis:
- other: mean out of all 3 eyes
- Time point:
- other: 4 h
- Score:
- 6.185
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance
- Irritation parameter:
- other: IVIS
- Basis:
- other: mean out of all 3 eyes
- Time point:
- other: 4 h
- Score:
- 90.3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: positive control
- Irritation parameter:
- other: opacity
- Basis:
- other: mean out of all 3 eyes
- Time point:
- other: 4 h
- Score:
- 59
- Reversibility:
- other: not applicable
- Remarks on result:
- other: positive control
- Irritation parameter:
- other: permeability
- Basis:
- other: mean out of all 3 eyes
- Time point:
- other: 4 h
- Score:
- 2.086
- Reversibility:
- other: not applicable
- Remarks on result:
- other: positive control
- Other effects:
- Corneal epithelium condition and post incubation:
The corneas of the negative control were clear, whereas the corneas of the positive control were cloudy. After treatment with the test item the corneas were slightly cloudy.
Any other information on results incl. tables
Table 1: Opacity values
Parameter |
Initial opacity |
Final opacity |
Opacity change |
Mean opacity change of NC |
Corrected opacity change |
Mean opacity value |
Negative control |
4 |
6 |
2 |
3.7 |
- |
- |
4 |
7 |
3 |
||||
3 |
9 |
6 |
||||
Test substance |
3 |
19 |
16 |
- |
12.3 |
13.0 |
2 |
23 |
21 |
17.3 |
|||
3 |
16 |
13 |
9.3 |
|||
Positive control |
2 |
67 |
65 |
- |
61.3 |
59.0 |
3 |
65 |
62 |
58.3 |
|||
3 |
64 |
61 |
57.3 |
Table 2: Permeability values (optical density (OD) at 492 nm)
Parameter |
OD492 |
Corrected OD492 change |
Mean OD492 value |
Negative control |
0.048 |
0.060 |
|
0.067 |
|||
0.065 |
|||
Test substance |
6.195 |
6.135 |
6.185 |
6.245 |
6.185 |
||
6.295 |
6.235 |
||
Positive control |
1.449 |
1.389 |
2.086 |
3.420 |
3.360 |
||
1.570 |
1.510 |
Table 3:In-Vitro Irritancy Score (IVIS) values
Mean IVIS |
|
Negative Control |
4.6 |
Test substance |
105.8 |
Positive control |
90.3 |
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Cat. 1, H318
DSD: Xi, R41
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