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EC number: 271-843-1 | CAS number: 68609-93-8
- 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:
- From February 10, 2014 to August 12, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: The OTWG of ICCVAM and the NICEATM, Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The Bovine Corneal Opacity and Permeability (BCOP) Test Method, March 2006.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: In Vitro Techniques in Toxicology Database (INVITTOX) protocol 127. Bovine Opacity and Permeability (BCOP) Assay, 2006.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449, 1992.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- EC Number:
- 271-843-1
- EC Name:
- 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- Cas Number:
- 68609-93-8
- Molecular formula:
- A generic formula cannot be provided for this UVCB substance. The alkyl chain length of the sulfonated fatty acids range from C12-C22, however the major alkyl chain is C18.
- IUPAC Name:
- 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- Test material form:
- other: powder/flakes with lumps
- Details on test material:
- - Name of test material (as cited in study report): 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- Physical state: Beige-yellow powder/flakes with lumps (i.e., determined at WIL Research Europe B.V.)
- Analytical purity: 100%
- Water content: 0.5%
- pH: 6 at concentration of 1g/L
- Lot/batch No.: 7495382
- Expiration date of the lot/batch: December 31, 2015
- Storage condition of test material: At room temperature in the dark
- Stability in vehicle: Water: Yes
- Solubility in vehicle: Water: Completely miscible
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine eyes
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µL 10% (w/w) solution of test substance
- Duration of treatment / exposure:
- 10±1 minutes
- Observation period (in vivo):
- After the completion of the incubation period (i.e., 120±10 minutes) opacity determination was performed
- Details on study design:
- Preparation of corneas
- The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by submersing them in physiological saline and holding them in the light. Those exhibiting defects were discarded.
- The isolated corneas were stored in a petri dish with cMEM (Eagle’s Minimum Essential Medium (Invitrogen Corporation, Breda, The Netherlands) containing 1% (v/v) L-glutamine (Invitrogen Corporation) and 1% (v/v) Foetal Bovine Serum (Invitrogen Corporation)). The isolated corneas were mounted in a corneal holder (i.e., one cornea per holder) of MC2 (Clermont, France) with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32±1°C. The corneas were incubated for the minimum of 1 h at 32±1°C.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 10 minutes
- Value:
- 22
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The corneas treated with the test substance showed opacity values ranging from 4 to 7 and permeability values ranging from 0.603 to 1.752. The corneas were translucent after the 10 minutes of treatment with the test substance. A pH effect of the test substance was observed on the rinsing medium, the corneas were rinsed until no colour change of the medium was observed. Hence, the in vitro irritancy scores ranged from 13 to 33 after 10 minutes of treatment with test substance.
Any other information on results incl. tables
Negative and positive controls:
The individual in vitro irritancy scores for the negative controls ranged from -1.0 to 0.1. The individual positive control in vitro irritancy scores ranged from 164 to 186. The corneas treated with the positive control were turbid after the 10 minutes of treatment.
In Vitro irritancy score
Eye |
Negative control correctedFinal Opacity |
Negative control correctedFinal OD490 |
In vitro Irritancy Score1 |
Negative control |
|||
1 |
-1 |
-0.002 |
-1.0 |
2 |
0 |
-0.005 |
-0.1 |
3 |
0 |
0.008 |
0.1 |
Positive control |
|||
4 |
115 |
4.596 |
183.9 |
5 |
114 |
4.806 |
186.1 |
6 |
82 |
5.430 |
163.5 |
Test substance |
|||
7 |
7 |
1.752 |
33.3 |
8 |
5 |
1.073 |
21.1 |
9 |
4 |
0.603 |
13.0 |
1 In vitro irritancy score (IVIS) = opacity value + (15 x OD490value).
Summary of opacity, permeability and in vitroscores (10% solution, 10 minutes treatment)
Treatment |
Mean Opacity |
Mean Permeability |
Mean In vitro Irritation Score1, 2 |
Negative control |
0 |
0.000 |
0 |
Positive control |
104 |
4.944 |
178 |
Test substnace |
5 |
1.143 |
22 |
1 Calculated using the negative control mean opacity and mean permeability values.
2 In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490value).
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the study conditions, mean in vitro irritancy score for the test substance was established at 22, and hence no prediction can be made regarding its eye irritation potential.
- Executive summary:
A study was conducted to determine the eye irritation potential of the test substance according to OECD Guideline 437 (Bovine Corneal Opacity and Permeability test), in compliance with GLP. The test substance (750 µL of a 10% w/w solution) was applied topically onto the epithelium of the bovine cornea for 10±1 minutes at 32±1°C. After exposure, the corneas were washed with MEM (Minimum Essential Medium), phenol red and cMEM (Eagle's Minimum Essential Medium), then incubated for 120±10 minutes at 32±1°C. Opacity and permeability were determined. The negative control responses for opacity and permeability were within laboratory historical control ranges. The mean in vitro irritancy score of the positive control (10% w/v benzalkonium chloride) was 178, which was also within the historical control range. Under the study conditions, mean in vitro irritancy score for the test substance was established at 22, and hence no prediction can be made regarding its eye irritation potential (Verspeek, 2014).
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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