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EC number: 939-582-4 | CAS number: 1471315-26-0
- 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:
- 4 Jul - 9 Aug 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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)
- Version / remarks:
- adopted 7. September 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Landesinstitut für Arbeitsschutz und Produktsicherheit, München
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered), aluminum salts
- EC Number:
- 939-582-4
- Cas Number:
- 1471315-26-0
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, C16-18 (even numbered), aluminum salts
- Details on test material:
- - Name of test material (as cited in study report): Fatty acids, tallow, hydrogenated, aluminium salts
- Physical state: white solid powder
- Analytical purity: 84.33%
- Impurities (identity and concentrations): ash content 9.17%; humidity 0.75%; free fatty acids 14.13%; water-soluble salts 0.61%; aluminium 4.13%
- Lot/batch No.: C200752-001
- Expiration date of the lot/batch: 14.02.2014
- Storage condition of test material: at room temperature
- Other: CAS 91770-05-7
Constituent 1
Test animals / tissue source
- Species:
- other: cattle
- Strain:
- other: bovine corneas
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM PREPARATION
- Source: isolated corneas obtained as a by-product from an abattoir from freshly slaughtered animals (Attenberger Fleisch GmbH & Co. KG, München)
- cornea preparation: on test day, fresh eyes were transported in HBSS containing Pen/Strep (5%) on ice. For cornea preparation, tissue surrounding the eyeball was carefully pulled away and corneas were excised leaving a 2 to 3 mm rim of sclera. Isolated corneas were stored in petri dishes containing HBSS.
- Cornea holders: corneas were mounted with the endothelial side against the O-ring of the posterior chamber, anterior chamber is positioned on top of of the cornea and tightend with screws, chamber of the cornea holder is filled with RPMI (without Phenol Red) containing 1% FBS and 2 mM L-glutamine, the posterior chamber was filled first, corneas were preincubated for one hour.
Test system
- Vehicle:
- other: sesame oil
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 20% in vehicle - Duration of treatment / exposure:
- 4 hours ± 5 min
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- 3 corneas each per treatment
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): after removal of the treatment medium, with MEM, once the medium was macroscopically free of test substance the corneas were rinsed with RPMI (without phenol red) and anterior chambers were filled with fresh RPMI for opacity measurements
- Time after start of exposure: 4 hours
EVALUATION OF RESULTS:
- mean opacity value: calculated by subtracting the initial opacity reading (before treatment) from the final reading (after exposure), these values were corrected by subtracting from each the average change in opacity from corresponding negative control, the mean then was calculated by averageing the corrected opacity values for each treatment group
- permeability measurements (fluorescein): mean OD490 for each treatment were calculated by substracting the blank from each value and by subtracting the average corrected negative control value from the corrected value of each treatment measurement, the mean then was calculated by averaging the corrected OD490 values by averaging the corrected values for each treatment group
- IVIS score: (In Vitro Irritation Score) - calculated by summing up the mean OD490 score multiplied by 15 with the mean opacity value for each treatment
TOOL USED TO ASSESS SCORE: fluorescein + measurement of optical density at 490 nm and visual inspection, after opacity measurement
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: IVIS Score
- Basis:
- other: negative control
- Time point:
- other: 4 hours
- Score:
- 1.1
- Irritation parameter:
- other: IVIS Score
- Basis:
- other: positive control
- Time point:
- other: 4 hours
- Score:
- 216.51
- Irritation parameter:
- other: IVIS Score
- Basis:
- other: negative control (vehicle)
- Time point:
- other: 4 hours
- Score:
- 0.05
- Irritation parameter:
- other: IVIS Score
- Basis:
- other: test item
- Time point:
- other: 4 hours
- Score:
- 1.32
- Irritant / corrosive response data:
- no effects on the corneas were observed
- Other effects:
- no other effects observed
Any other information on results incl. tables
Table2: In Vitro Irritation Score
Cornea No. |
Test Item |
Corrected Opacity Value |
Corrected OD490 Value |
IVIS |
1 |
Negative Control |
1.00 |
0.087 |
|
2 |
0.00 |
0.089 |
|
|
3 |
-2.00 |
0.110 |
|
|
MV |
-0.33 |
0.095 |
1.10 |
|
4 |
Positive Control |
203.33 |
2.007 |
|
5 |
178.33 |
1.710 |
|
|
6 |
182.33 |
1.986 |
|
|
MV |
188.00 |
1.901 |
216.51 |
|
10 |
Negative Control Sesame Oil |
-1.00 |
0.063 |
|
11 |
0.00 |
0.030 |
|
|
12 |
-1.00 |
0.051 |
|
|
MV |
-0.67 |
0.048 |
0.05 |
|
7 |
Test Item |
0.67 |
0.026 |
|
8 |
1.67 |
-0.045 |
|
|
9 |
1.67 |
0.017 |
|
|
MV |
1.33 |
-0.001 |
1.32 |
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- According to Regulation (EC) No. 1272/2008, a substance can be considered a severe eye irritant (Serious eye damage Category 1/R41) based on a positive result in the Bovine Corneal Opacity and Permeability (BCOP) test. Negative in vitro corrosivity responses are not conclusive with respect to non-classification or classification as irritant (Category 2/R36) and shall therefore be subject to further evaluation."
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