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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
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- 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
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
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- Nanomaterial catalytic activity
- Endpoint summary
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- Environmental data
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- 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
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- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Sodium pyrithione has tested negative in the ames assay, the in vitro CHO/HGPRT forward mutation assay, the in vitro rat hepatocyte primary culture/DNA repair test and in the in vivo mouse micronucleus assay [see tables 7.6.1 & 7.6.2].
All studies proved negative with the exception of one unscheduled DNA synthesis (UDS) study in the rat and the sodium salt of pyrithione was evaluated in the UDS. The results from the UDS [reference 7.6.1.005, EZPTF 6067 -001] indicated that pyrithione (tested as sodium pyrithione) failed to induce a mean net nuclear grain count of plus five or greater over the control and vehicle control indicating a clear negative result for inducing DNA synthesis. The two highest concentrations of sodium pyrithione tested induced cytotoxicity demonstrating that sufficient test article was delivered to the test system
Based on the wealth of negative mutagenicity and genotoxicity studies in in vitro and in vivo test systems, sodium pyrithione is not genotoxic.
Table 7.6.1 Summary of genotoxicity in vitro
Test system |
Organism/ |
concentrations |
Result |
Remark |
Reference |
|
+ S9 |
- S9 |
|||||
EEC Council Directive 2000/32, Annex 4D; GLP
Test material Natrium Pyrion 40% |
S. typhimurium: |
Experiment 1: 0; 6.25; 12.5; 25; 50; 100 µg a.s./plate; Experiment 2, strains TA 1535, TA 98, TA 100, TA 102: Experiment 2, strain TA1537: 0; 1.56; 3.13; 6.25; 12.5; 25; 50 µg a.s./plate |
Negative |
Negative |
The test substance did not induce two-fold increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose level, in any tester strain, in the absence or presence of S9 metabolism. |
7.6.1.001
ESPTF 6061-001
Scarcella O, Brightwell J (2002). (unpublished). |
Non-GLP study
Test Material – Sodium Pyrithione 40% aqueous solution |
S. typhimurium: |
5 µg/plate 10 µg/plate 15 µg/plate 20 µg/plate 25 µg/plate
0.6 µg/plate 1.2 µg/plate 1.8 µg/plate 2.4 µg/plate 3.0 µg/plate |
Negative Negative Negative Negative Negative
|
Negative Negative Negative Negative Negative
|
The test substance did not induce two-fold increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose level, in any tester strain, in the absence or presence of S9 metabolism. |
7.6.1.006
ESPTF 6061-002
E.I. du Pont de Nemours and Co. Haskell Laboratory (1976) |
EEC Council Directive 2000/32, Annex 4A; GLP
Test material Natrium Pyrion 40% |
Chinese hamster lung fibroblasts (V79) |
Concentrations used: 0; 0.313; 0.625; 1.25; 2.50; 5.00; 10.0; 20.0; 40.0; 80.0 µg a.s./mL Concentrations scored: 0; 20.0; 40.0; 80.0 µg a.s./mL |
Yes |
Yes |
The test substance induces chromosomal aberrations in Chinese hamster V79 cells after in vitro treatment under the reported experimental conditions. |
7.6.1.002
ESPTF 6062-001
Iliutti P, Brightwell J (2002). (unpublished). |
EEC Council Directive 2000/32, Annex 4E; GLP
Test material Natrium Pyrion 40% |
Chinese hamster V79 cells |
1(-) 1250; 938; 625; 313; 156; 78.1
313; 234; 156; 78.1; 39.1; 19.5 2(-) 1875; 1250; 833; 556; 370; 247 2(+) 470; 313; 209; 139; 92.8; 61.9
(µg a.s./mL) |
No |
No |
No reproducible five-fold increases in mutant numbers or mutant frequency were observed following treatment with the test substance at any dose level, in the absence or presence of S9 metabolism. |
7.6.1.003
ESPTF 6063-001
Cinelli S, Brightwell J (2002). (unpublished). |
GLP Study under USEPA Guideline 84-2
Test Material – Sodium pyrithione 40% aqueous solution |
CHO-K1-BH4 cells from stock cultures of known stable spontaneous mutant grequency and mycoplasm free cells |
0.005 µg/plate 0.010 µg/plate 0.020 µg/plate 0.035 µg/plate 0.050 µg/plate 0.100 µg/plate 0.200 µg/plate 0.350 µg/plate 0.500 µg/plate
0.500 µg/plate 1.00 µg/plate 2.50 µg/plate 5.00 µg/plate 10.00 µg/plate 25.00 µg/plate 75.00 µg/plate 100 µg/plate |
Negative Negative Negative Negative Negative Negative Negative Negative Negative
|
Negative Negative Negative Negative Negative Cytotoxic Cytotoxic Cytotoxic |
The average mutant frequency of the negative control cultures ranged from 1.2 to 8.5 TG mutants/106clonable cells, while those of the cultures treated with sodium pyrithone ranged from 1.0 to 10.5 TG mutants/106clonable cells.
Statistical analysis of the data indicate that there is no dose-dependent increases in the mutant frequencies in the test article treated cultures.
Sodium pyrithione was negative in the CHO/HRPT Mammalian Cell Forward Gene Mutation. |
7.6.1.004
ESPTF 6063-002
Stankowski (1987)
(unpublished)
|
Mammalian rat hepatocyte primary culture/DNA Repair Test GLP
Test material NaPT 40% aqueous solution |
Rat hepatocytes from one rat |
1x10-5viable hepatocytes Two hr incubation at 37ºC, cells serum free medium containing test article and3H-thymidine was added to each culture. |
|
0.067, 0.050, 0.167, 0.50, 1.67, 5.0, 16.7, 50.0, 166.7 and 500 ng/ml |
Negative After 7-days of exposures, autoradiograhs were developed and UDS “repair” synthesis evidenced by a net increase in black silver grains over the nucleus is quantified by determining nuclear and cytoplasmic grain counts. |
NaPT even at cytotoxic levels failed to produce a mean net nuclear grain count of plus 5 or greater than vehicle control mean net nuclear grain counts. |
7.6.1.005
EZPTF 6067-001
Barfknecht, T.R. (1987)
(unpublished)
|
Table 7.6.2 Summary of genotoxicity in vivo
Type of test |
Species |
frequency of application |
sampling times |
dose levels |
Results
|
Remarks |
Reference |
Directive 2000/32/EC, B.12;
GLP
Natrium Pyrion solid (92.5%) |
Mouse Crl:NMRI BR. Charles River
5m, 5f per dose per sampling time |
Once by oral gavage |
24 & 48 hours |
400, 482, 580 mg/kg bw |
No statistically significant increase in the amounts of micronucleated polychromatic erythrocytes was observed at any dose tested compared to the negative controls, neither 24 nor 48 hours after treatment, neither for males nor for females. Bioavailability of the test substance was proven by mortality and by cytotoxicity at the high dose. |
The test substance does not produce relevant increases of the numbers of micronuclei in polychromatic erythrocytes after in vivo treatment of mice of either sex of the test strain at doses of 400, 482 and 580 mg/kg bw. |
7.6.2.001
ESPTF 6064-001
Bornatowicz N (2002).
(unpublished). |
In vivoMouse Micronucleus Test USEPA Guideline 84-2 consistent with OECD 474
Test Article: Sodium Pyrithione 40% aqueous solution |
CRL 5 male and 5 female mice per dose |
Once by Intraperitoneal injection. |
30, 48 and 72 hours post dosing. |
TEM (positive control) 0.5 kg/kg Distilled water 10 ml/kg NaPT 575 mg/kg
|
No statistically significant increase in the amounts of micronucleated polychromatic erythrocytes was observed at the dose tested compared to the negative controls, neither 30, 48, or 72 hours after treatment, neither for males nor for females.. |
The test substance does not produce relevant increases of the numbers of micronuclei in polychromatic erythrocytes after in vivo treatment of mice of either sex of the test strain at a dose of 575 mg/kg bw. |
7.6.2.002
ESPTF 6064-002
Sorg, R.M. (1987) (unpuglished) |
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
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