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EC number: 223-296-5 | CAS number: 3811-73-2
- 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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Based upon studies in animals and in humans (table 7.4.1 below), Sodium Pyrithione is not classified as sensitizing. In two GLP studies compliant to OECD 406, [references 7.4.1.001, ESPTF 6015-001 ; 7.4.1.002, ESPTF 6015-002], it was determined that Sodium Pyrithione is non-sensitizing.
Table 7.4.1 Summary of sensitisation
Species
Method
Number of animals sensitised/total number of animals
Result
Reference
Guinea pig (female)
OECD 406, 1992: Skin Sensitisation,
Directive 96/54/EC, B.6.Guinea Pig Maximisation Test.
Test material Sodium Pyrion powder (>92.5%)
2/20
Non sensitising
3 females were administered intra-dermally with Freund`s adjuvant, the test substance (50 % w/w) was applied epicutaneously to the sites of the intradermal injections. 7 days later 4 concentrations of the test substance (50 %, 25 %, 10 % and 1 %) were administered epicutaneously to the flanks of the animals. The duration of the exposure was 24 hours. Skin reactions were severe erythema at 50 %, very slight erythema at 25 % and no reaction at 10 % and 1 %.
After the challenge exposure, 2/20 animals of the test substance group had positive skin reactions 24 h after the end of the exposures. No adverse skin reactions were observed in the control animals. Therefore 2/20 animals of the test substance group (10 %) were regarded as sensitised, which is below the threshold of 30 % for classification as a sensitising substance.
Key Study
7.4.1.001
ESPTF 6015-001
Weiss-Fuchs U (2002)
(unpublished)
Guinea pig
(male)
US EPA 81-6, which complies with OECD 406 (Buehler method). GLP (self certification by the laboratory).
Test material: Sodium Omadine® solution (43.7%).
2/10 , 3/10
Non-sensitising.
Induction A: Scores for erythema were generally severe on the intradermal sites dosed with FCA and FCA/test article mixture and mild to severe on the sites dosed with test article only.
Induction B: Erythema was mild to severe following a 48 hour exposure to a 10% dilution of test article.
Challenge: Following a 24 hour exposure to a 5% dilution of the test article, mild erythema was observed in 2/10 (20%) animals 24.5 hours post does. At 48 hours, 3/10 (30%) animals had mild erythema.
7.4.1.001
ESPTF 6015-002
(unpublished)
Justification for classification or non-classification
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