Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 246-929-7 | CAS number: 25383-99-7
- 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:
- 09 Dec 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- 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 2017
- 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)
- Version / remarks:
- adopted in 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material
- Reference substance name:
- Sodium 2-stearoyllactate
- EC Number:
- 246-929-7
- EC Name:
- Sodium 2-stearoyllactate
- Cas Number:
- 25383-99-7
- Molecular formula:
- This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molecular weight, SMILES, InChI and structural formula cannot be given.
- IUPAC Name:
- sodium 2-hydroxy-2-methyl-3-oxoicosanoate
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: AB Schlachthof GmbH & Co. KG, 63739 Aschaffenburg, Germany
- Characteristics of donor animals: 14 months old
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Hank’s Buffered Salt Solution (HBSS) containing 1% (v/v) penicillin/streptomycin (100 units/mL penicillin and 100 μg/mL streptomycin), cooled in the slaughter-house and during transport.
- Time interval prior to initiating testing: The eyes were transported on the morning of slaughter of the donor animals to the laboratory. The corneae were isolated on the same day after delivery of the eyes.
- indication of any existing defects or lesions in ocular tissue samples: The eyes were carefully examined macroscopically for defects. Only eyes without defects (e.g. vascularization, pigmentation, opacity and scratches) were used in the assay.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.75 mL
- Concentration: 20% suspension (w/v) in saline using sonication for 10 min - Duration of treatment / exposure:
- 240 min at 32 ± 1 °C
- Number of animals or in vitro replicates:
- Triplicates for each treatment and control group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The cornea was carefully removed from the eye using scalpel and rounded scissors. A rim of about 2 mm of tissue (sclera) was left for stability and handling of the isolated cornea. Each cornea was mounted in a specially designed cornea holder.
QUALITY CHECK OF THE ISOLATED CORNEAS
At the end of the equilibration period, the basal opacity was determined (t0). Each cornea with a value of the basal opacity > 7 was discarded.
TREATMENT METHOD: closed chamber
The endothelial side of the cornea was positioned against the O-ring of the posterior part of the holder. The cornea was gently flattened over the O-ring but stretching was avoided. 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. The posterior compartment was filled first to return the cornea to its natural convex position. Care was taken to assure that no air bubbles were present within the compartments.
REMOVAL OF TEST SUBSTANCE
After exposure, the test substance was rinsed off from the corneae with Eagle’s minimum essential medium (EMEM) containing phenol red for at least three times or more until phenol red was still discoloured (yellow or purple), or the test item was still visible. Since the test item proved difficult to be removed by the rinsing method, the front cover of the holder was opened and the cornea was carefully washed using a gentle stream of incubation medium. Once the medium was free of the test item the corneae were given a final rinse with complete Minimum Essential Medium (cMEM) without phenol red.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer (OP_KiT opacitometer (Electro Design, 63-Riom, France)).
- Corneal permeability: Passage of sodium fluorescein dye measured with the aid of a microplate reader (Versamax® Molecular Devices, Software SoftMax Pro Enterprise version 4.7.1) (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
Test substance with an IVIS > 55 was regarded as serious eye damage and labelled Category 1 according to CLP/EPS/GHS.
Test substance with an IVIS ≤ 3 was regarded as non-irritant and labelled in no category.
For test substance with an IVIS in the range > 3 ≤ 55 no prediction can be made.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 240 min exposure
- Value:
- 2.27
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
The technical proficiency of the test facility was demonstrated. Appropriate data are provided in 'Any other information on results incl. tables' below.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, the negative control resulted in opacity and permeability values that were less than the established upper limits for background opacity and permeability values for bovine corneae treated with the respective negative control.
- Acceptance criteria met for positive control: yes, the positive control resulted in an IVIS which was within two standard deviations of the current historical mean.
Any other information on results incl. tables
Table 1: Details on results
Test Group |
Opacity value = Difference (t240-t0) of Opacity |
Permeability at 490 nm (OD490) |
IVIS |
Mean IVIS |
Standard Deviation in vitro score |
Proposed in vitro Irritancy Score |
|||
|
|
Mean |
|
Mean |
|
|
|
|
|
Negative Control |
0 |
0.00 |
0.067 |
0.062 |
1.01 |
0.94 |
0.06 |
No Category |
|
0 |
0.059 |
0.89 |
|||||||
0 |
0.061 |
0.92 |
|||||||
Positive Control |
95.00* |
0.161* |
97.41 |
106.87 |
8.61 |
Category 1 |
|||
111.00* |
0.217* |
114.25 |
|||||||
107.00* |
0.130* |
108.95 |
|||||||
Test Substance |
1.00* |
0.010* |
1.15 |
2.27 |
0.97 |
No Category |
|||
2.00* |
0.056* |
2.84 |
|||||||
2.00* |
0.055* |
2.82 |
* corrected values
Table 2: Historical control data
|
Positive Control |
Negative Control |
Mean IVIS |
113.39 |
1.29 |
Standard Deviation of IVIS |
12.73 |
0.32 |
Range of IVIS |
87.39 - 146.55 |
0.77 - 2.85 |
95 % Control limits of IVISpos |
87.92-138.85 |
|
Mean Opacity t240min |
110.20 |
0.25 |
Standard Deviation of Opacity t240min |
18.98 |
0.32 |
Range of Opacity t240min |
54.00 - 187.00 |
0.00 - 1.33 |
Mean Permeability |
0.21 |
0.07 |
Standard Deviation of Permeability |
0.29 |
0.01 |
Range of Permeability |
-0.02 - 1.96 |
0.05 - 0.10 |
Values of 83 studies with solid test items sharing 46 sets of controls, performed between January 2016 and July 2019.
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.
- Conclusions:
- Under conditions of the Bovine Corneal Opacity and Permeability Test (BCOP) the test substance was not irritating to the eye. Application of the test substance to bovine corneas resulted in a calculated mean IVIS of 2.27.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.