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Diss Factsheets
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EC number: 200-386-2 | CAS number: 58-56-0
- 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:
- 23 Feb 2015 - 10 Mar 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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)
- Version / remarks:
- adopted July 26, 2013
- 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:
- Official Journal of the European Union No. L324; Amended by EC No. 1152/2010 No. L142, 09 December 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: In Vitro Techniques in Toxicology Database (INVITTOX) protocol 127. Bovine Opacity and Permeability (BCOP) Assay, 2006
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: The Ocular Toxicity Working Group of the Interagency Coordinating Committee on the Validation of Alternative Methods and the National Interagency Centre for the Evaluation of Alternative Toxicological Methods (March 2006)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pyridoxine hydrochloride
- EC Number:
- 200-386-2
- EC Name:
- Pyridoxine hydrochloride
- Cas Number:
- 58-56-0
- Molecular formula:
- C8H11NO3.ClH
- IUPAC Name:
- 4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol hydrochloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Pyridoxine Hydrochloride (Vitamin B6)
- Substance type: Organic
- Physical state: White powder
- Stability under test conditions: stable
- Storage condition of test material: At room temperature protected from light
- pH: 2.7 at concentration of 5% in water
Constituent 1
Test animals / tissue source
- Species:
- other: in vitro
Test system
- Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 μl of a 20% (w/v) suspension
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea
POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 20% (w/v) Imidazole
- Duration of treatment / exposure:
- 240 ± 10 minutes
- Details on study design:
- TEST SITE
- Isolated bovine cornea
REMOVAL OF TEST SUBSTANCE
- Washing: yes (with MEM with phenol red (Eagle’s Minimum Essential Medium, Invitrogen Corporation) and thereafter with cMEM)
- Time after start of exposure: 10 minutes
SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by incubation for 120 ± 10 minutes in cMEM. Then, corneas were incubated in sodium-fluorescein solution for 90 ± 5 minutes (both incubations at 32 ± 1°C).
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader
DATA EVALUATION:
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces an IVIS > 55 is defined as a corrosive or severe irritan (UN GHS: category 1);
For a test substance that induces an IVIS >3 and ≥ 55, no prediction on irritant potency can be made (UN GHS: no prediction can be made)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean of three replicates
- Value:
- 94.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- The corneas treated with the positive control were turbid after the 240 minutes of treatment. The corneas treated with Pyridoxine Hydrochloride (Vitamin B6) showed opacity values ranging from 68 to 106 and permeability values ranging from 0.114 to 0.131. The corneas were turbid after the 240 minutes of treatment with Pyridoxine Hydrochloride (Vitamin B6). 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
Any other information on results incl. tables
Summary of opacity, permeability and resulting IVIS
Treatment |
Mean opacity ± SD |
Mean Permeability ± SD |
Mean In vitro Irritation Score ± SD |
Negative control |
0.0 ± 3.5 |
0.000 ± 0.004 |
0.0 ± 3.4 |
Positive control |
87.7 ± 23.1 |
1.708 ± 0.372 |
113.3 ± 22.6 |
Pyridoxine Hydrochloride (Vitamin B6) |
92.7 ± 21.4 |
0.122 ± 0.009 |
94.5 ± 21.5 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Since Pyridoxine Hydrochloride (Vitamin B6) induced an IVIS ≥ 55 in the Bovine Corneal Opacity and Permeability test performed according to EC/ OECD guidelines and GLP principles, it is concluded that Pyridoxine Hydrochloride (Vitamin B6) should be regarded as severely irritant to the eye (category 1).
- Executive summary:
Pyridoxine Hydrochloride (Vitamin B6) was tested in the Bovine Corneal Opacity and Permeability test performed according to EC/ OECD guidelines and GLP principles. The negative control response of the opacity and permeability values was acceptable. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 113 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Pyridoxine Hydrochloride (Vitamin B6) induced serious eye damage through both endpoints (opacity and permeability), resulting in a mean in vitro irritancy score of 95 after 240 minutes of treatment.
Based on an IVIS of 95, it is concluded that Pyridoxine Hydrochloride (Vitamin B6) induces serious eye damage and is classified category 1 (irreversible effects on the eye).
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