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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
Endpoint summary
Administrative data
Description of key information
Two studies on skin irritancy are available: (1) An in vitro skin irritation test was conducted according to OECD/EC guidelines and GLP principles. It is concluded that this test is valid and that pyridoxine hydrochloride (Vitamin B6) is not irritating in the in vitro skin irritation test; (2) A 20% solution of pyridoxine chloride was tested on intact and abraded skin of 6 rabbits. No skin irritation was observed. Due to limitations in the study outline it was found to have reliability 4 and is used as supporting evidence.
Pyridoxine Hydrochloride (Vitamin B6) was tested in the Bovine Corneal Opacity and Permeability test performed according to EC/ OECD guidelines and GLP principles. Since the test substance induced an IVIS ≥ 55, it is concluded that Pyridoxine Hydrochloride (Vitamin B6) should be regarded as severely irritant to the eye. A supporting test is available, in which 6 rabbits were instilled with 0.1 mL of a 15% aqueous solution of the test substance. Mild iriitation was observed which resolved within 48 hours.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 Feb 2015 - 15 feb 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.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 26 July 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- adopted 20 July 2012
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- human
- Details on test animals or test system and environmental conditions:
- ENVIRONMENTAL CONDITIONS
- Temperature (°C): 36.7 - 37.2
- Humidity (%): 63-89
- CO2 (%): 5.0 ± 0.5 - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amounts applied: 21.0 to 23.0 mg, the skin was moistened with 10 µl Milli-Q water.
NEGATIVE CONTOL:
- Amount applied: 25 µl Phosphate buffered saline
POSITIVE CONTROL
- Amount applied: 25 µl
- Concentration: 5% (aq) Sodium dodecyl sulphate - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Number of animals:
- 3 (number of replicates)
- Details on study design:
- TEST SITE
- EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 15-EKIN-006). This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
REMOVAL OF TEST SUBSTANCE
- Washing: phosphate buffered saline
- Time after start of exposure: 15 ± 0.5 minutes
POST INCUBATION PERIOD
- 42 hours
SCORING SYSTEM:
- Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. - Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 101
- Remarks on result:
- other:
- Remarks:
- Basis: other: percentage of control. Time point: 15 minutes. Remarks: Negative control = 100%; Positive control = 11%. (migrated information)
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- An in vitro skin irritation test was conducted according to OECD/EC guidelines and GLP principles. It is concluded that this test is valid and that Pyridoxine Hydrochloride (Vitamin B6) is not irritating in the in vitro skin irritation test.
- Executive summary:
In an in vitro skin irritation test using a human skin model ( EPISKIN Standard Model), the influence of the test substance on the viability of human skin was tested. The test substance was applied directly to 0.38 cm2 cultured skin (21.0 to 23.0 mg, in presence of 10 μl Milli-Q water). After 15 minutes, the substance was removed and cells were cultured for 42 hours. The viability of the cells was tested by reduction of MTT. Survival of unexposed skin was set at 100%, the positive control had a mean cell viability of 11% whereas the test substance showed cell viability of 101%. Since the mean relative tissue viability after exposure to the test substance was above 50%, it can be concluded that the test substance is non-irritant in the in vitro skin irritation test.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1981
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- No details on substance purity, no Lot/batch number given in the report. Amount applied is not sufficient for classification purposes (0.5 mL of 20% solution). Observation time was 48 hours. No information on test animals given (sex, age, source, clinical signs, body weight measurements).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register, 37 (244): 27635-6, December 19, 1972
- Principles of method if other than guideline:
- Test substance was applied to intact and abraded skin. Exposure was done occlusively instead of semi-occlusively as recommended in the guideline. Observation time was 48 hours instead of 72 hours. Scoring was limited to erythema/ eschar formation and edema formation following the primary index scores listed in the Federal Register 37 (244): 27636, December 19, 1972. No clinical signs or body weight measurements were included. No data on test animals (sex, age, source). The test sites were washed with ethanol.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml of a 20% solution.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 48 hours
- Number of animals:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with ethanol
- Time after start of exposure: 4 hours
SCORING SYSTEM: Erythema and eschar formation were scored (scale 0-4) and edema formation was scored (range 0-4), following the primary index scores listed in the Federal Register 37 (244): 27636, December 19, 1972. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- other: 24 and 48 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- other: 24 and 48 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact and abraded skin
- Irritant / corrosive response data:
- No skin effects were seen on intact and abraded skin at 24 and 48 hours afer removal of the test substance.
- Interpretation of results:
- other: data insufficient for classification
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- A 20% solution of pyridoxine chloride was tested on intact and abraded skin of 3 rabbits. No skin irritation was observed.
- Executive summary:
A 20% solution of pyridoxine chloride was tested on intact and abraded skin of 3 rabbits. Occlusive exposure of 0.5 ml of the solution did not cause skin irritation. The tested concentration is too low to allow conclusions on irritancy of the pure test substance.
Referenceopen allclose all
Pyridoxine Hydrochloride (Vitamin B6) was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test substance to MTT medium. Because no colour changes were observed it was concluded that Pyridoxine Hydrochloride (Vitamin B6) did not interact with the MTT endpoint.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 29 SEP 1981 - 05 OCT 1981
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: No details on test substance purity. amount applied (0.1mL of 15% aquoeus solution) is not sufficient for classification purposes.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 15% solution tested, 6 animals used instead of 3 as recommended
- GLP compliance:
- no
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- IN-LIFE DATES: From: 29 SEP 1981 To: 05 OCT 1981
- Vehicle:
- water
- Remarks:
- 15% concentration
- Controls:
- other: untreated eye served as concurrent control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration (if solution): 15% - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: According to Draize's method as described in Food and Drug cosmetic Law J. 10: 722 (1955) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24 hours
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Weak conjunctival irritation of the exposed eyes was seen in all animals 1 hour after instillation and in 3/6 animals after 24 hours (score 1= Some vessels definitely injected). All effects had resolved after 48 hours.
- Other effects:
- No alteration of the corneas was found macroscopically.
- Conclusions:
- An in vivo eye irritation test was performed with 6 rabbits. Instillation was done with 0.1 mL of 15% aqueous solution of pyridoxine hydrochloride. Weak conjunctival irritation of the exposed eyes was seen in all animals 1 hour after instillation and in 3/6 animals after 24 hours. All effects had resolved after 48 hours.
- 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.
- 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
- Species:
- other: in vitro
- 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) - 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
- 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).
Referenceopen allclose all
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Two studies are available which address skin irritancy of pyridoxine hydrochloride. Both studies show no indications that the substance has skin irritating properties. In an in vitro skin irritation test using a human skin model ( EPISKIN Standard Model), the influence of the test substance on the viability of human skin was tested. The test substance was applied directly to 0.38 cm2cultured skin (21.0 to 23.0 mg, in presence of 10 μl Milli-Q water). After 15 minutes, the substance was removed and cells were cultured for 42 hours. The viability of the cells was tested by reduction of MTT. Survival of unexposed skin was set at 100%, the positive control had a mean cell viability of 11% whereas the test substance showed cell viability of 101%. Since the mean relative tissue viability after exposure to the test substance was above 50%, it can be concluded that the test substance is non-irritant in the in vitro skin irritation test. Furthermore, a 20% solution of pyridoxine chloride was tested on intact and abraded skin of 3 rabbits. Occlusive exposure of 0.5 ml of the solution did not cause skin irritation. The tested concentration is too low to allow conclusions on irritancy of the pure test substance.
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. Furthermore a supporting study is available. In this in vivo eye irritation test 6 rabbits were instilled with 0.1 mL of a 15% aqueous solution of pyridoxine hydrochloride. Weak conjunctival irritation of the exposed eyes was seen in all animals 1 hour after instillation and in 3/6 animals after 24 hours. All effects had resolved after 48 hours.
Justification for selection of skin irritation / corrosion
endpoint:
One study available performed according to OECD/EC guidelines and
according to GLP principles.
Justification for selection of eye irritation endpoint:
One study available performed according to OECD/EC guidelines and
according to GLP principles.
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Based on the available data, pyridoxine hydrochloride is not classified for irritant properties to the skin, but it is classified for serious effects on the eye (cat.1) according to CLP Regulation (EC) No. 1272/2008.
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