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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
- 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:
- 2014-09-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study. Deviation: When a 20% w/v formulation in saline was prepared the test item was considered to be unsuitable for dosing. Therefore in accordance with the methods described within the OECD BCOP test guideline, the test item was applied neat onto the corneal surface.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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:
- yes
- Remarks:
- When a 20% w/v formulation in saline was prepared the test item was considered to be unsuitable for dosing. Therefore in accordance with the methods described within the OECD BCOP test guideline, the test item was applied neat onto the corneal surface.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The department of health of the government of the United Kingdom
Test material
- Reference substance name:
- Amides, C18, branched and linear
- Molecular formula:
- Not applicable as UVCB
- IUPAC Name:
- Amides, C18, branched and linear
- Test material form:
- solid: pellets
- Details on test material:
- - Name of test material (as cited in study report): Amides, C18, branched and linear
- Physical state: extremely pale yellow granular solid
- Lot/batch No.: 202637
- Expiration date of the lot/batch: 20 April 2016
- Stability under test conditions: stable
- Storage condition of test material: at RT, protect from light
- Analytical purity: 100%
Constituent 1
Test animals / tissue source
- Species:
- other: cattle
- Strain:
- other: bovine eyes from young cattle
- 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 for identifying i) chemicals inducing serious eye damage and ii) chemicals not requiring classification for eye irritation or serious eye damage. 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 invitro 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
- Transport medium and temperature conditions: The eyes were placed in HBSS supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 µg/mL) and transported to the test facility over ice packs on the same day of slaughter.
PREPARATION OF THE EYES (BEFORE EXPOSURE)
- Eyes free of defects (scratches, neovascularisation): yes
- Dissection of the eyes and treatment: 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: cMEM (Eagle’s Minimum Essential Medium); prior to use: prewarmed to 32 ± 1 °C
- Equilibration time: 1 h at 32 ± 1 °C
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:
- unchanged (no vehicle)
- Controls:
- other: number of eyes for the negative control: 3; number of eyes for the positive control: 3
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied in the test: 0.3 g
NEGATIVE SUBSTANCE
- Substance: sodium chloride solution
- Concentration (if solution): 0.9% (w/v) NaCl solution in deionised water
POSITIVE SUBSTANCE
- Substance: Imidazole
- Concentration (if solution): 20% (w/v) Imidazole in 0.9% (w/v) NaCl solution in deionised water - Duration of treatment / exposure:
- 4 h
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- number of eyes for the test item: 3
- Details on study design:
- TEST CONDITIONS
- Open-Chamber method: After dosing, the glass window was replaced on the anterior chamber to recreate a closed system. Corneas were exposed for 4 h with the test substance or the controls. The glass window from the anterior chamber was removed prior to treatment. The controls or test substance were applied directly to the epithelial surface of the cornea.
POSTEXPOSURE TREATMENT
- Removal of the test substance: The test substance was removed from the anterior chamber and the cornea was rinsed three times.
- Medium for washing the corneas: MEM containing phenol red
- Medium for final rinsing: complete MEM
DETERMINATION OF THE FINAL OPACITY
- Method: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
- Time of determination: Directly after refilling fresh cMEM without phenol red in the anterior chamber the final opacity was measured.
DETERMINATION OF THE CORNEAL PERMEABILITY
- Method: The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution. The dosing holes were plugged and the holders incubated, anterior chamber uppermost. 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; dissolved in cMEM)
- Incubation time: 90 min at 32 ± 1 °C
- Treatment for measuring: OD492 of a 360 μL aliquot was determined in a 96-well plate
- Specification of the spectrophotometer: Anthos 2001 microplate reader
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Three experiments run with an exposure time of 4 hours
- Value:
- ca. 0
- Negative controls validity:
- valid
- Remarks:
- Mean opacity change of NC 1.0
- Positive controls validity:
- valid
- Remarks:
- Mean opacity value if 56.0
- Remarks on result:
- no indication of irritation
- Remarks:
- Please see the "Any other information on results incl. tables" for more detailed info on results.
- Irritation parameter:
- other: Permeability values (optical density (OD) at 492 nm)
- Run / experiment:
- Three experiments run with an exposure time of 4 hours
- Value:
- ca. 0.019
- Negative controls validity:
- valid
- Remarks:
- Mean OD492 value is 0.073
- Positive controls validity:
- valid
- Remarks:
- Corrected mean OD492 value is 1.461
- Remarks on result:
- no indication of irritation
- Remarks:
- Please see the "Any other information on results incl. tables" for more detailed info on results.
- Irritation parameter:
- in vitro irritation score
- Remarks:
- IVIS
- Run / experiment:
- Three experiments run with an exposure time of 4 hours
- Value:
- ca. 0.3
- Negative controls validity:
- valid
- Remarks:
- Mean IVIS 2.1
- Positive controls validity:
- valid
- Remarks:
- Mean IVIS 77.9
- Remarks on result:
- no indication of irritation
- Remarks:
- Please see the "Any other information on results incl. tables" for more detailed info on results.
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 |
1 |
2 |
1 |
1.0 |
- |
- |
|
1 |
2 |
1 |
|||||
1 |
2 |
1 |
|||||
Test substance |
1 |
2 |
1 |
- |
0.0 |
0.0 |
|
1 |
2 |
1 |
0.0 |
||||
2 |
2 |
0 |
0.0 |
||||
Positive control |
0 |
60 |
60 |
- |
59 |
56.0 |
|
0 |
59 |
59 |
58 |
||||
3 |
55 |
52 |
51 |
Table 2: Permeability values (optical density (OD) at 492 nm)
Parameter |
OD492
|
Mean OD492 value |
Corrected OD492
|
Corrected Mean OD492 value |
Negative control |
0.076 |
0.073 |
- |
- |
0.073 |
||||
0.070 |
||||
Test substance |
0.095 |
- |
0.022 |
0.019 |
0.100 |
0,027 |
|||
0.081 |
0.008 |
|||
Positive control |
1.533 |
- |
1.460 |
1.461
|
1.536 |
1.463 |
|||
1.533 |
1.460 |
Table 3: In-Vitro Irritancy Score (IVIS) values
|
Mean IVIS |
Negative control |
2.1 |
Test substance |
0.3 |
Positive control |
77.9 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.