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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
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 208 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Dose descriptor:
- LC50
- Value:
- 1.08 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
7.2.1 Acute oral toxicity studies
Two acute oral toxicity data studies (see Table 3.2 below) indicate that sodium Pyrithione meets the criteria for classification as harmful by the oral route (LD50 = 965 mg/kg, R22 Harmful if swallowed.). The two most significant studies are discussed below.
In a GLP study to OECD 401 by Allen DJ (1996) [reference 7.2.1.001, ESPTF 6011-001 ] the results were as follows:
Mortality
was noted during the day of dosing and up to 2 days after dosing.
Signs of systemic toxicity were noted in all dosed groups. Surviving
animals recovered 3 to 8 days after dosing.
Surviving animals gained weight during the study.
Necropsy
of the decedents revealed haemorrhagic or abnormally red lungs, dark
liver or patchy pallor of the liver, dark kidneys and haemorrhage of
the gastric mucosa, slight haemorrhage of the small intestine also
noted in one female. Necropsy of the animals killed at study
termination showed no macroscopically visible findings except for one
female treated with 1265 mg.
LD50females: 1208 (965 - 1512) mg active ingredient/kg b.w.
According to the EU classification criteria Sodium Pyrithione should be classified as harmful and the symbol Xn and risk phrase R22- harmful if swallowed.
In a GLP Study carried out underUS EPA Series 81-1 criteria by Cerven DR (1997):[reference 7.2.1.002 , ESPTF 6011-002 ] the results were:
Mortality was noted during the day of dosing and up to 7 days after dosing. Signs of systemic toxicity were noted in all dosed groups. Surviving animals recovered 3 to 8 days after dosing. Surviving animals gained weight during the study except one male dosed at 2000 mg/kg.
Necropsy
of the decedents revealed aemorrhagic or abnormally red lungs, dark
liver or patchy pallor of the liver, dark kidneys and hemorrhage of
the gastric mucosa. Necropsy
of the animals sacraficed at study termination showed similar findings
but to a lesser degree with the majority of surviving animals showing
no macroscopically visible findings.
LD50male/females: 1500 (1300 - 1700) mg 40% sodium Omadine/kg b.w.
According to the EU classification criteria Sodium Omadine should be classified as harmful and the symbol Xn and risk phrase R22- harmful if swallowed.
According to the EU classification criteria Sodium Pyrithione should be classified as harmful and the symbol Xn and risk phrase R22- harmful if swallowed.
7.2.2 Acute inhalation toxicity studies
One inhalation toxicity study has been carried out (see Table 3.2 below).
In a
GLP compliant whole body study, Drummond (1987), [reference
7.2.2.001, ESPTF 6013-001], carried out to US EPA Series 81-3
criteria the results were as follows:
Mortality
was seen at all of the exposure levels, with most of the deaths
occurring on the first day post dose. Toxicologically
significant pharmacotoxic signs, such as labored breathing, were
noted at all exposure levels. Due
to high mortality at the higher dose levels, body weight effects
could only be assessed at the two lowest doses. Weight
gain was depressed at both doses during the two-week post-exposure
period. Pulmonary
congestion was the most common macroscopic observation at necropsy. No
gross pulmonary abnormalities were seen in animals that survived the
observation period.
It should be noted that these values were likely exacerbated by
ingestion of the test substance and so the values determined should
be considered very much worst case.
A combined LC50value (males + females) of 1.08 mg/L (95%
confidence limits = 0.71 – 1.66 mg/L)
The substance is classified as harmful and assigned the risk phrase R20 Harmful by inhalation
7.2.3
Acute dermal toxicity studies
Acute dermal toxicity studies (see Table 7.2.1 below) have been carried
out in both rats and rabbits. These studies indicate that the dermal
route of exposure warrants no classification.
In a GLP study with rats, conducted to OECD 402 criteria by Bernat E (2001)[reference 7.2.3.001, ESPTF 6012-001], the results were as follows:
No
other than local toxic effects of the test substance (eschar
formation) were noted during the study. All animals gained weight in
both weeks after administration. No abnormalities at necropsy and no
mortality were detected.
LD50: > 2000 mg/kg.
According to the EU classification criteria Sodium Omadine should not be classified for dermal toxicity.
In a GLP study with rabbits, conducted to US EPA FIFRA series 81-2 criteria by Cerven DR (1987) [reference 7.2.3.002, ESPTF 6012-002], the results were as follows:
Clinical signs of emaciation , few feces, ptosis, unkempt appearance, diarrhea, alopecia, ataxia, bloated abdomen, soiling of the anogenital area, pupilary dilation, wetness and yellow staining of the fore limbs, yellow nasal discharge, and alopecia.
The combined male and female dermal LD50is 1800 mg 40% Sodium Omadine/kg b.w.
According
to the EU classification criteria Sodium Pyrithione should be
classified as harmful and the symbol Xn and risk phrase R21- harmful
in contact with skin.
Table 7.2.1 Summary of acute toxicity
Route |
Method |
Species |
dose levels |
Value |
Remarks |
Reference |
Oral Sodium Pyrithion: 40% Aqueous solution of sodium pyrithione |
OECD 401: Acute Oral Toxicity GLP (self certification by the laboratory) |
Rat Sprague-Dawley CD, 5 males and 5 females in the 2000 mg/kg dose group |
800, 1265 and 2000 mg active ingredient/kg b.w 14 days post exposure period |
LD50females: 1208 (965 - 1512) mg active ingredient/kg b.w. |
Mortality was noted during the day of dosing and up to 2 days after dosing. |
Key Study
7.2.1.001
ESPTF 6011-001
Allen DJ (1996) (unpublished).
|
Oral, Sodium Omadine®: 40% aqueous solution of sodium pyrithione
|
US EPA Series 81-1: Acute Oral Toxicity |
Rat Wistar albino 5 males and 5 females per dose
|
1000; 1100; 1200; 1500; 1900; 2000; and 2500 mg 40% Sodium Omadine/kg of bw |
Females: 1100 mg/kg b.w Males: 2000 mg/kg b.w. Combined Males & Females: 1,500 mg/kg b.w. (1300 – 1700 mg/kg) |
Mortality was noted during the day of dosing and up to 7 days after dosing.
|
7.2.1.002
ESPTF 6011-002
Cerven DR (1987) (unpublished) |
Dermal Natrium Pyrion: sodium pyrithione solid >92.5% |
OECD 402: Acute dermal Toxicity GLP (self certification by the laboratory) |
Rat Sprague-Dawley CD 5 per sex |
2000 mg a.i./kg bw (limit test). 14 days post exposure period |
LD50>2000 mg/kg bw |
No other than local toxic effects of the test substance (eschar formation) were noted during the study. All animals gained weight in both weeks after administration. No abnormalities at necropsy and no mortality were detected. |
7.2.3.001
ESPTF 6012-001
Bernat E (2001) (unpublished) |
Dermal Sodium Omadine® 40% aqueous solution |
US EPA FIFRA Series 81-2: Acute dermal Toxicity by the laboratory) |
New Zealand albino rabbits 5 per sex |
1500, 1650, 1800, & 2000 mg/kg |
combined male and female dermal LD50is 1800 mg 40% Sodium Omadine/kg b.w. |
Clinical signs of emaciation , few feces, ptosis, unkempt appearance, diarrhea, alopecia, ataxia, bloated abdomen, soiling of the anogenital area, pupilary dilation, wetness and yellow staining of the fore limbs, yellow nasal discharge, and alopecia. |
Key Study
7.2.3.002
ESPTF 6012-002
Cerven DR (1987)
(unpublished) |
Inhalation (whole body) 40% (nominal) solution of sodium Omadine (active ingredient). |
Environmental Protection Agency Pesticide Assessment Guidelines, Subdivision F, Series 81-3 Hazard Evaluation: Human and Domestic Animals, Section 81-3, which is comparable to OECD 102 and EC B.2. GLP (self certification by the laboratory) |
Rat Sprage-dawley 5 per sex |
Nominal concentrations: 6.6, 8.1, 18.6, 23.7, and 25.9 mg/L Analytical concentrations: 0.14, 0.58, 0.79, 0.95, and 1.4 mg/L 6.6, 8.1, 18.6, 23.7, and 25.9 mg/L 6.6, 8.1, 18.6, 23.7, and 25.9 mg/L |
A combined LC50value (males + females) of 1.08 mg/L (95% confidence limits = 0.71 – 1.66 mg/L) |
Mortality was seen at all of the exposure levels, with most of the deaths occurring on the first day post dose. Toxicologically significant pharmacotoxic signs, such as labored breathing, were noted at all exposure levels. Due to high mortality at the higher dose levels, body weight effects could only be assessed at the two lowest doses. Weight gain was depressed at both doses during the two-week post-exposure period. Pulmonary congestion was the most common macroscopic observation at necropsy. No gross pulmonary abnormalities were seen in animals that survived the observation period. |
Key Study 7.2.2.001
ESPTF6013-001
Drummond JG (1987) (unpublished) |
The information contained within this robust summary document comes from studies which are in the ownership of Arch Chemicals Inc. and which are protected in several regions globally. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under RegulationEC 1907/2006.
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