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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
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 0.5 mg/kg bw/day
Carcinogenicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 5 mg/kg bw/day
Justification for classification or non-classification
Additional information
Available studies are presented in Table 7.7.1 below. Studies have been carried out in the rat and the mouse.
In studies with Sodium Omadine, with oral sampling with rat and dermal sampling with mouse, no evidence of tumourigenic potential was identified.
A GLP study to Guideline US EPA 83-2, which complies with OECD 453. by Husband (1991),[reference 7.7.002, EZPTF 6051-001], investigated the oral (gavage) administration of Sodium Pyrithione to rats over 104 weeks. This study constituted a combined carcinogenicity / chronic toxicity study.
Sodium Pyrithione did not affect tumour formation adversely. Decreases in body weight gain, hind limb muscle atrophy and histopathological changes in skeletal muscle, spinal cord, and in the eyes were observed in the high dose group. Some, but not all of these effects were observed to a lesser degree in the mid dose group.
An NOEL of 0.5 mg/kg bw/day was established in the study.
A GLP study to Guideline US EPA 83-2, which complies with OECD 453. by Husband (1991), [reference 7.7.001, EZPTF 6071-001], investigated the DERMAL) administration of Sodium Pyrithione to the mouse over 80 weeks. This study constituted a carcinogenicity study.
Sodium Omadine did not affect tumour formation adversely. The only observed lesion, which appeared to be related to the treatment, was epidermal hyperplasia at the application sites of high and mid dose animals.
An NOEL of 5.0 mg/kg bw/day was established in the study.
A GLP study to Guideline US EPA OPPTS 870.4300 which complies with OCED 453,by Civalese et al (2004), [reference 7.7.003, EZPTF 6051-002], investigated the oral (gavage) administration of Sodium Pyrithione to rats over 104 weeks. This study constituted a combined carcinogenicity / chronic toxicity study.
Signs of toxicity, such as, ataxia, decreased muscle tone and emaciation were seen in animals of both sexes. In addition, a lower body weight was noted in low and high-dose males and in mid- and high- dose females when compared to controls.
Low dose males were sacrificed on week 97 due to the high mortality observed compared to controls and mortality of the mid- and high-dose females (1.5, 2.1 mg/kg/day) was higher than controls. However, there were no indications of significant different incidences of predominant pathology between control and treated animals.
There were no incidences of neoplasia with sodium Pyrithione up to 2.8 mg/kg/day.
An NOAEL for both sexes can be considered to be 0.5 mg/kg/day.
Table 7.7.1 Summary of chronic toxicity/carcinogenicity
Route |
Duration |
Species |
Dose levels |
Results |
LO(A)EL |
NO(A)EL |
Reference |
[mg/kg bw/day] |
|||||||
Oral (gavage) |
2 years |
Rat Crl: CD (SD) (VAF Plus) 50 per sex per dose |
US EPA 83-2, which complies with OECD 453. GLP 0, 0.5, 1.5 and 3.5 mg/kg bw/day
Test material: Sodium Omadine®, 41.2% aqueous dispersion. |
Sodium Omadine did not affect tumour formation adversely. Decreases in body weight gain, hind limb muscle atrophy and histopathological changes in skeletal muscle, spinal cord, and in the eyes were observed in the high dose group. Some, but not all of these effects were observed to a lesser degree in the mid dose group. |
1.5 mg/kg bw/day |
0.5 mg/kg bw/day |
7.7.002
EZPTF 6051-001
Husband RFA, Newman AJ and Lee PN (1991) (unpublished) |
Oral (gavage) |
2 years |
Rat |
US EPA 83-2, which complies with OECD 453. GLP
Test material: Natrium Pyrion 40 % LSG. |
Signs of toxicity, such as, ataxia, decreased muscle tone and emaciation were seen in animals of both sexes. In addition, a lower body weight was noted in low and high-dose males and in mid- and high- dose females when compared to controls.Low dose males were sacrificed on week 97 due to the high mortality observed compared to controls and mortality of the mid- and high-dose females (1.5, 2.1 mg/kg/day) was higher than controls. However, there were no indications of significant different incidences of predominant pathology between control and treated animals.
There were no incidences of neoplasia with sodium Pyrithione up to 2.8 mg/kg/day.
There were treatment related degenerative changes of the sciatic nerve and skeletal muscle in all treatment groups and gastric reactive change at 2.8 mg/kg/day in male rats only. |
|
0.5 mg /kg bw/day |
Key study 7.7.003
EZPTF 6051-002
Cicalese R, Argentino-Storino A, (2004) (unpublished) |
Dermal |
80 weeks |
Mouse Crl: CD-1 (ICR) BR (VAF Plus) 50 per sex per dose |
US EPA 83-2, which complies with OECD 453. GLP 0, 5, 15 and 40 mg/kg bw/day Test material: Sodium Omadine®, 41.2% aqueous dispersion.
|
Sodium Omadine did not affect tumour formation adversely. The only observed lesion, which appeared to be related to the treatment, was epidermal hyperplasia at the application sites of high and mid dose animals. |
15 mg/kg bw/day |
5 mg/kg bw/day |
7.7.001
EZPTF 6071-001
Husband RFA, Newman AJ and Lee PN (1991) (unpublished)
|
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