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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 941-484-1 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- 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:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 3-methyl-1-octylpyridinium chloride and 4-methyl-1-octylpyridinium chloride
- EC Number:
- 941-484-1
- Molecular formula:
- not possible
- IUPAC Name:
- Reaction mass of 3-methyl-1-octylpyridinium chloride and 4-methyl-1-octylpyridinium chloride
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- The assay uses isolated corneas obtained as a by-product from animals freshly slaughtered at the abattoir.
On the test day, fresh eyes were collected from the slaughterhouse and were transported in HBSS containing Pen/Strep on ice to the laboratories.
Immediately after arrival of the eyes, cornea preparation was initiated. The eyes were carefully examined for defects and any defective eyes were discarded.
The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS. Before the corneas were mounted in corneal holders with the endothelial side against the O-ring of the posterior chamber, they had been visually examined for defects and any defective cornea had been discarded. The anterior chamber was then positioned on top of the cornea and tightened with screws. The chambers of the corneal holder were then filled with RPMI (without phenol red) containing 1% FBS and 2 mM L-glutamine (complete RPMI). The posterior chamber was always filled first. The corneas were incubated for one hour at 32 ± 1 °C in a water bath.
The calibration of the opacitometer was performed before each test and was documented in the raw data.
After the equilibration period, the medium was removed from both chambers and replaced with fresh complete RPMI. An initial opacity measurement was performed on each of the corneas using an opacitometer (MC2, Clermont, France). Three corneas with opacity readings approximately equivalent to the median opacity of all corneas were selected as negative-control corneas. The opacity of each cornea was read against an air-filled chamber and recorded. Corneas that have an initial opacity reading above 7 units were not dosed. The medium was removed from the anterior chamber and replaced with the test item or control.
Enough of the test substance to cover the whole cornea was introduced into the anterior chamber by removing the window-locking ring and glass window prior to treatment. 750 μL of the control substance was introduced into the anterior chamber (closed chamber method). After 10 minutes incubation at 32 ± 1 °C either the test substance or the control substance was removed and the epithelium washed at least three times with MEM (containing phenol red). Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI (without phenol red). The anterior chamber was refilled with complete RPMI and an opacity measurement was performed after 2 hours incubation at 32 ± 1 °C.
After the opacity measurement was performed, the medium was removed from both chambers of the holder. The posterior chamber was refilled with fresh complete RPMI. Sodium fluorescein solution was added to the anterior chamber and the corneas were incubated for 90 minutes at 32 ± 1 °C. Then the medium from the posterior chamber was removed and its optical density at 490 nm (OD490) was determined, using a spectrophotometer.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative control and positive control
- Amount / concentration applied:
- Enough of the test substance to cover the whole cornea was introduced into the anterior chamber by removing the window-locking ring and glass window prior to treatment.
750 μL of the control substance was introduced into the anterior chamber (closed chamber method). - Duration of treatment / exposure:
- 10 minutes incubation at 32 ± 1 °C
- Number of animals or in vitro replicates:
- 3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive control treated with ethanol 100% - Details on study design:
- Enough of the test substance to cover the whole cornea was introduced into the anterior chamber by removing the window-locking ring and glass window
prior to treatment. 750 μL of the control substance was introduced into the anterior chamber (closedchamber method).
After 10 minutes incubation at 32 ± 1 °C either the test substance or the control substance was removed and the epithelium washed at least three times with MEM (containing phenol red). Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI (without phenol red). The anterior chamber was refilled with complete RPMI and an opacity measurement was performed after 2 hours incubation at 32 ± 1 °C.
After the opacity measurement was performed, the medium was removed from both chambers of the holder. The posterior chamber was refilled with fresh
complete RPMI. 1 mL of a 4 mg/mL sodium fluorescein solution was added to the anterior chamber and the corneas were incubated for 90 minutes at 32 ± 1 °C. Then the medium from the posterior chamber was removed and its optical density at 490 nm (OD490) was determined, using a spectrophotometer.
Results and discussion
In vivo
- Irritant / corrosive response data:
- The following mean in vitro irritation score was calculated: 86.08
Therefore the test item is classified as corrosive / severe irritant to the eye (UN GHS Category 1)
Any other information on results incl. tables
Bovine Corneal supplier: Abattoir A. Moksel AG, Buchloe, Germany.
In Vitro Irritation Score:
Cornea No. |
Test Item | Corrected Opacity |
Corrected OD490 Value |
IVIS |
1 | Negative Control |
0.0 | 0.025 | 0.91 |
2 | 1.0 | 0.008 | ||
3 | 1.0 | 0.016 | ||
MV | 0.67 | 0.016 | ||
4 | Positive Control |
60.33 | 2.046 | 80.10 |
5 | 46.33 | 2.036 | ||
6 | 42.33 | 2.005 | ||
MV | 49.67 | 2.029 | ||
7 | Test Item | 52.33 | 2.096 | 86.08 |
8 | 42.33 | 2.098 | ||
9 | 69.33 | 2.090 | ||
MV | 54.67 | 2.094 |
Opacity:
Cornea No. |
Test Item | Initial Opacity |
Final Opacity |
Change of Opacity Value |
Corrected Opacity Value |
1 | Negative Control |
3 | 3 | 0 | |
2 | 3 | 4 | 1 | ||
3 | 3 | 4 | 1 | ||
MV | 3.00 | 3.67 | 0.67 | ||
4 | Positive Control |
4 | 65 | 61 | 60.33 |
5 | 4 | 51 | 47 | 46.33 | |
6 | 4 | 47 | 41 | 42.33 | |
MV | 4.00 | 54.33 | 50.33 | 49.67 | |
7 | Test Item | 1 | 54 | 53 | 52.33 |
8 | 4 | 47 | 43 | 42.33 | |
9 | 2 | 72 | 70 | 69.33 | |
MV | 2.33 | 57.67 | 55.33 | 54.67 |
Permeability:
Cornea No. |
Test Item | OD490 | Corrected OD490 Value |
1 | Negative Control |
0.025 | |
2 | 0.008 | ||
3 | 0.016 | ||
MV | 0:016 | ||
4 | Positive Control |
2.062 | 2.046 |
5 | 2.052 | 2.036 | |
6 | 2.021 | 2.005 | |
MV | 2.045 | 2.029 | |
7 | Test Item | 2.112 | 2.096 |
8 | 2.114 | 2.098 | |
9 | 2.106 | 2.090 | |
MV | 2.111 | 2.094 |
Historical mean In Vitro Irritation Score of the positive control:
IVIS Positive Control |
|
Mean Value (MV) | 75.72 |
Standard Deviation (SD) | 12.24 |
MV- 2xSD | 51.24 |
MV+2xSD | 100.19 |
MV = Mean Value
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- According to the evaluation criteria the test item Pyridine derivative 2 is classified as corrosive / severe irritant to the eye (UN GHS Category 1).
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.