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EC number: 205-443-5 | CAS number: 140-93-2
- 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
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 4 months
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Read-across from potassium salt
Some limitations in terms of details in the Australian Government review, but allows for classification
The potassium salty is considered suitable as a source of data for the corresponding sodium salt
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Extended to 4 months
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- ENVIRONMENTAL CONDITIONS
After an adequate acclimatisation period (at least five days), the animals were barrier maintained (full-barrier) in air conditioned rooms under the following conditions: temperature: 22 ± 3 °C, relative humidity: 55 ± 10%, artificial light, sequence being 12 hours light, 12 hours dark, air change: 10 x / hour, free access to Altromin 1324 maintenance diet, free access to tap water, sulphur acidified to a pH of approximately 2.8 (drinking water, municipal residue control, microbiol. controlled periodically), housed individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- 4 months
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- At least weekly checks to confirm stability and achieved concentrations
- Duration of treatment / exposure:
- 4 months
- Frequency of treatment:
- Daily
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control
- Dose / conc.:
- 5 mg/kg bw/day (nominal)
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Dose / conc.:
- 15 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 20 animals per sex
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Potassium butyl xanthate was administered orally (0,5, 10 and 15 mg/kg) to rats, rabbits and dogs for 4 months. During administration effects observed from week 6 to week 7 of treatment were tachypnoea, cyanosis, loss of hair and dermatitis. Loss of weight and increase in blood sugar and cholesterol were observed later. Convulsions and paralysis of the extremities were observed in some animals from week 9 of administration. Some animals died during the administration.
- Observations and examinations performed and frequency:
- Daily clinical observations.
At least weekly body weights.
During administration effects observed from week 6 to week 7 of treatment were tachypnoea, cyanosis, loss of hair and dermatitis. Loss of weight and increase in blood sugar and cholesterol were observed later. Convulsions and paralysis of the extremities were observed in some animals from week 9 of administration. Some animals died during the administration.
- Sacrifice and pathology:
- Gross necropsy and pathology performed
- Statistics:
- Yes, as applicable
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- tachypnoea, cyanosis, loss of hair and dermatitis. Convulsions and paralysis of the extremities were observed in some animals from week 9 of administration.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Some animals died during the administration.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Loss of weight
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Endocrine findings:
- not specified
- Urinalysis findings:
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- A slight decrease in testes weight in highest group males was observed when compared to control animals, but not statistically significant.
Individual animals in different groups showed other adverse effects, but not considered treatment related and not considered significant. - Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Most changes minor and of limited significance.
tachypnoea, cyanosis, loss of hair and dermatitis - Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Individual animals in different groups showed some adverse effects, but not considered treatment related and not considered significant.
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- During administration effects observed from week 6 to week 7 of treatment were tachypnoea, cyanosis, loss of hair and dermatitis. Loss of weight and increase in blood sugar and cholesterol were observed later. Convulsions and paralysis of the extremities were observed in some animals from week 9 of administration. Some animals died during the administration.
- Dose descriptor:
- LOAEL
- Effect level:
- 10 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: see 'Remark'
- Critical effects observed:
- not specified
- Organ:
- liver
- spleen
- Conclusions:
- Findings were included central nervous system, liver and spleen effects.
- Executive summary:
During administration effects observed from week 6 to week 7 of treatment were tachypnoea, cyanosis, loss of hair and dermatitis. Loss of weight and increase in blood sugar and cholesterol were observed later. Convulsions and paralysis of the extremities were observed in some animals from week 9 of administration. Some animals died during the administration
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 10 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Read-across from potassium salt
The potassium salty xanthates is considered suitable as a source of data for the corresponding sodium salt xanthates
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- GLP compliance:
- not specified
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: Analysis of the particle size indicated that all the particles at the lower dose of 100 mg/m3 were less than 10μm in diameter while approximately 80% of the particles had a diameter of 10μm or less at a dose of 800 mg/m3. It is not possible to state from the description of the exposure method whether air flow was dynamic or static.
- Details on inhalation exposure:
- Animals were exposed to potassium amyl xanthate as an aqueous aerosol. Attempts at dust exposure were unsuccessful as potassium amyl xanthate is hygroscopic.
Animals were exposed to concentrations of 0, 100 and 800 mg/m3 of potassium amyl xanthate. These concentrations were equivalent to actual doses of 0, 23 and 252 mg/m3. Analysis of the particle size indicated that all the particles at the lower dose of 100 mg/m3 were less than 10μm in diameter while approximately 80% of the particles had a diameter of 10μm or less at a dose of 800 mg/m3. It is not possible to state from the description of the exposure method whether air flow was dynamic or static.
Exposure levels for the study were established by a preliminary experiment. In the preliminary experiment, three groups of 10 male Sprague-Dawley rats were exposed to concentrations of 0, 200 or 800 mg/m3 of potassium amyl xanthate, 6 hrs daily for 10 exposures in 2 weeks. No signs of toxicity were observed in animals exposed to a concentration of 200 mg/m3. Rats exposed to a concentration of 800 mg/m3 showed a statistically significant decrease in body weight after the fifth exposure. Recovery of the body weight occurred within 4 days and may not have been exposure related.
The only substance related adverse effect observed was a yellow-brown staining of the hair coat of the rats.
Overexposure of the animals exposed to a concentration of 800 mg/m3 occurred because of a technical problem in the aerosol generating apparatus. - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 30-day
- Frequency of treatment:
- 6 hrs daily, 5 days a week for a total of 20 exposures in 1 month
- Dose / conc.:
- 0 mg/m³ air (nominal)
- Remarks:
- Control
- Dose / conc.:
- 100 mg/m³ air (nominal)
- Remarks:
- Doses / Concentrations:100 mg/m3Basis:nominal conc.
- Dose / conc.:
- 800 mg/m³ air (nominal)
- Remarks:
- Doses / Concentrations:800 mg/m3Basis:nominal conc.
- No. of animals per sex per dose:
- 2
- Control animals:
- yes
- Details on study design:
- In the 30-day study, three groups of animals, each consisting of 10 male Swiss- Webster mice, 10 male Sprague-Dawley rats, 4 male New Zealand White rabbits and 2 male beagle dogs were exposed to either filtered room air or to concentrations of 100 or 800 mg/m3 of potassium amyl xanthate. Whole body exposure was for 6 hrs daily, 5 days a week for a total of 20 exposures in 1 month.
Ten mice of the 800 mg/m3 group died along with 5/6 replacement mice.
The animals were observed during the exposures and body weights were recorded three times a week throughout the experiment. Body weight data, organ to body weight ratios and clinical laboratory parameters were analysed statistically using analysis of variance and Dunnett’s test.
Most of the mice died when exposed to 800 mg/m3. Five of the 16 mice that died showed convulsions and hyperactivity prior to death. The adverse effects produced by the two doses of potassium amyl xanthate are shown in Table 1. - Positive control:
- no data
- Observations and examinations performed and frequency:
- Animals were exposed to concentrations of 0, 100 and 800 mg/m3 of potassium amyl xanthate. These concentrations were equivalent to actual doses of 0, 23 and 252 mg/m3. Analysis of the particle size indicated that all the particles at the lower dose of 100 mg/m3 were less than 10μm in diameter while approximately 80% of the particles had a diameter of 10μm or less at a dose of 800 mg/m3. It is not possible to state from the description of the exposure method whether air flow was dynamic or static.
Exposure levels for the study were established by a preliminary experiment. In the preliminary experiment, three groups of 10 male Sprague-Dawley rats were exposed to concentrations of 0, 200 or 800 mg/m3 of potassium amyl xanthate, 6 hrs daily for 10 exposures in 2 weeks. No signs of toxicity were observed in animals exposed to a concentration of 200 mg/m3. Rats exposed to a concentration of 800 mg/m3 showed a statistically significant decrease in body weight after the fifth exposure. Recovery of the body weight occurred within 4 days and may not have been exposure related.
The only substance related adverse effect observed was a yellow-brown staining of the hair coat of the rats.
Overexposure of the animals exposed to a concentration of 800 mg/m3 occurred because of a technical problem in the aerosol generating apparatus. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, the presence of tumours in the lungs, liver, kidneys, pancreas, spleen and any other organs were recorded.
HISTOPATHOLOGY: Yes, the lungs, liver, kidneys, pancreas, spleen and any other organs with tumours were sampled at necropsy. - Other examinations:
- See table 1.
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- See table 1.
- Mortality:
- no mortality observed
- Description (incidence):
- See table 1.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- See table 1.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No statistically significant treatment related effects were observed.See table 1.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No statistically significant treatment related effects were observed.See table 1.
- Endocrine findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No significant differences were observed between the test and control groups. See table 1.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No significant differences were observed between the test and control groups. See table 1.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No significant differences were observed between the test and control groups. See table 1.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- No significant differences were observed between the test and control groups. See table 1.
- Dose descriptor:
- LOEC
- Effect level:
- 100 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Hepatotoxic effects
- Critical effects observed:
- not specified
- Conclusions:
- The results of this study indicate that potassium amyl xanthate has an adverse effect on the the liver in dogs. There were no treatment-related changes in the haematological or urinalysis values in any of the animals.
Reference
Table 1 Results of repeated inhalation study with potassium amyl xanthate in laboratory animals
|
| Dogs (2 animals)
| Rabbits (4 animals)
| Rats (10 animals)
| Mice (10,6 animals)
|
100 mg/m3
| Eyes
| No irritation
| No irritation
| No irritation
| No irritation
|
| Nasal effects
| No effects
| No effects
| No effects
| No effects
|
| Hair coat
| Yellow brown staining.
| Progressive yellow brown staining
| Yellow brown stainingof the hair coat of the rats.
| No staining
|
| Other effects
| Staining of the appendages and scrotum; ulceration of the skin in the scrotal region.
| None
| None
| None
|
| Body weight
| No change
| No change
| No change
| No change
|
| Organ weight
| No change
| No change
| No change
| Higher liver to body weight ratio than controls
|
| Liver enzyme changes
| Marked elevation of serum alanine aminotransferase and alkaline phosphatase activities
| No change
| No change
| No change
|
| Histopathology changes
| Hepatocellular degeneration, necrosis and inflammation
| No treatment related change
| No treatment related change
| No treatment related change
|
| Deaths
| None
| None
| None
| None
|
800 mg/m3
| Eye changes
| Excessive lacrimation
| Conjunctival redness
| No irritation
| No changes
|
| Nasal effects
| None
| None
| Reddish nasal discharge
| None
|
| Hair coat
| Yellow brown staining
| A more intense yellow brown
| Yellow brown staining
| No effects
|
| Skin
| Ulceration of the skin
| No effect
| No effect
| No effect
|
| Body weight
| No effect
| No effect
| No effect
| No effect
|
| Organ weight
| No change
| No change
| Higher liver to body weight ratio than controls
| Higher liver to body weight ratio than controls
|
| Liver enzyme changes
| Marked elevations of serum alanine aminotransferase and alkaline phosphatase activities.
| No changes
| High serum alanine aminotransferase activity
| No changes
|
| Histopathology changes
| Hepatocellular degeneration, necrosis and inflammation
| No changes
| Microscopically visible granular degeneration
| No changes
|
| Deaths
| None
| None
| One, but not related to exposure
| 10 from the original group and 5/6 replacement animals died. Convulsions hyperactivity in 5/16 prior to death.
|
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEC
- 100 mg/m³
- Study duration:
- subacute
- Species:
- dog
- Quality of whole database:
- Inhalation of potassium amyl xanthate produces adverse effects in the livers of dogs.
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the absence of reliable information, the data for potassium amyl xanthate (CAS# 2720-73-2) may be used as a surrogate for sodium )-Isopropyl dithiocarbonate (CAS# 140-93-2).
The target sites for Sodium Isopropyl xanthate, and other xanthates are the central nervous system, liver and kidneys. The adverse effects seen in the toxicity studies could be due to the xanthates (such as Sodium Isopropyl xanthate), their decomposition products or a combination of both.
There is no human information available concerning reproductive toxicity for xanthates (CHEMINFO ,2004, Chemical Profiles Created by CCOHS , www.ccohs.ca).
Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: other; neurologic: central nervous system
Repeated dose toxicity: inhalation - systemic effects (target organ) digestive: liver
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.