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EC number: 607-240-0 | CAS number: 23511-73-1
- 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:
- 11 Dec 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 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)
- Version / remarks:
- adopted in 2013
- Deviations:
- yes
- Remarks:
- the study was conducted prior to the adoption of the test guideline, according to the draft version (dated 14 Aug 2008)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-phenoxyethyl octanoate
- EC Number:
- 607-240-0
- Cas Number:
- 23511-73-1
- Molecular formula:
- C16H24O3
- IUPAC Name:
- 2-phenoxyethyl octanoate
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Slaughterhouse (Vitelco, 's-Hertogenbosch, the Netherlands)
- Storage, temperature and transport conditions of ocular tissue: Eyes were collected and transported in physiological saline in a suitable container
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 750 µL
CONTROLS
- Negative control: 750 µL
- Positive controls: 750 µL
- Concentration of positive control solution: Alkylbenzyldimethylammonium chloride 10% (w/v) in physiological saline and 99.9% ethanol - Duration of treatment / exposure:
- 10 ± 1 min
- Duration of post- treatment incubation (in vitro):
- 120 ± 10 min
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Corneas were isolated and cultured in cMEM supplemented with 1% (v/v) foetal bovine serum and 1% (v/v) L-glutamine at 32 ± 1 °C for a minimum of 1 h prior to the start of the experiment. Opacity determinations were performed on each of the corneas using an opacitometer. Corneas that had an initial opacity reading higher than 3 were not used. Three corneas were selected at random for each treatment group.
QUALITY CHECK OF THE ISOLATED CORNEAS
Eyes were carefully examined for defects by holding the eyes submersed in physiological saline; those exhibiting unaccetable defects (opacity, scratches, pigmentation, neovascularisation) were discarded
TREATMENT METHOD
Each cornea was mounted in a cornea holder with the endothelial side against the O-ring of the posterior part of the holder. Afterwards, the anterior part of the holder was positioned on top of the cornea and fixed in place with screws. Both compartments of the holder were filled with incubation medium. For equilibration, the corneas in the holder were incubated in at 32 ± 1 °C for at least one hour.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least 3
METHODS FOR MEASURED ENDPOINTS
- Corneal opacity: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM
In Vitro Irritancy Score (IVIS)
In vitro score range In vitro classification
0 - 3 Non irritant
3.1 - 25 Mild irritant
25.1 - 55 Moderate irritant
55.1 - 80 Severe irritant
> 80 Very severe irritant
DECISION CRITERIA
The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value)
The positive control in vitro irritancy score should be reasonably within the laboratory historical positive control data range.
- The uncorrected negative control in vitro irritancy score is less than 3.1
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean out of 3 eyes
- Value:
- 0.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- IVIS score of 157.9 for Alkylbenzyldimethylammonium chloride and 68.3 for ethanol, respectively
- Irritation parameter:
- other: Opacity
- Run / experiment:
- mean out of 3 eyes
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Mean opacity of 86 for Alkylbenzyldimethylammonium chloride and 24 for ethanol, respectively
- Irritation parameter:
- other: Permeability
- Run / experiment:
- mean out of 3 eyes
- Value:
- 0.009
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Mean permeability of 4792 for Alkylbenzyldimethylammonium chloride and 2950 for ethanol, respectively
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The individual in vitro irritancy scores for the negative controls was 0 for all three corneas.
- Acceptance criteria met for positive control: The individual positive control in vitro irritancy scores ranged from 145 to 165 for benzalkonium chloride and ranged from 60 to 83 for ethanol and were within the range of historical control data. The corneas treated with the positive control substances were opaque after the 10 minutes of treatment. Thus, the test system functioned properly.
- Range of historical values if different from the ones specified in the test guideline:
- Negative control: Range = -1.0 - 2.2; Mean = 0.3; SD = 0.6; n = 41
- Positive control: Range = 113.8 - 202.7; Mean = 163.4; SD = 22.1; n = 42
Any other information on results incl. tables
Table 1: Individual results
Eye No. | corrected final opacity | corrected final OD 450 | in vitro irritancy score | ||
individual | mean | ||||
negative control | 1 | 0 | 0.003 | 0 | 0 |
2 | 0 | 0 | 0 | ||
18 | 0 | -0.002 | 0 | ||
positive control A | 4 | 88 | 3.78 | 144.7 | 157.9 |
5 | 89 | 5.07 | 165.1 | ||
6 | 81 | 5.526 | 163.9 | ||
positive control B | 16 | 26 | 3.816 | 83.2 | 68.3 |
17 | 23 | 2.49 | 60.4 | ||
3 | 23 | 2.544 | 61.2 | ||
test substance | 13 | 0 | 0.006 | 0.1 | 0.1 |
14 | 0 | 0.023 | 0.3 | ||
15 | 0 | -0.002 | 0 |
A Benzalkonium chloride
B Ethanol
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
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