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EC number: 247-728-7 | CAS number: 26479-35-6
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 134 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 338 mg/m³
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA Guidance
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- ECHA Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA Guidance
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 38 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 786 mg/kg bw/day
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA Guidance
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- ECHA Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA Guidance
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
The most relevant routes of potential exposure to potassium allophonate to workers are the dermal and inhalation routes. Based on the available acute toxicity data (oral, dermal, inhalation), potassium allophonate is not likely an acute toxicant and, therefore, derivation of Derived No Effect Level (DNEL) for long-term exposures (DNELlong-term) will be sufficient to control potential risks associated with short-term exposures. In addition, based on the available data, potassium allophonate is not likely irritating to either the eyes or skin, or sensitising to the skin. Therefore, based on the available data, potassium allophonate does not appear to elicit local toxicity effects. As such, derivation of a DNEL for local effects is not necessary. Therefore, only a long-term DNEL will be derived for potassium allophonate. Based on the paucity of repeat dose toxicity data available specifically on potassium allophonate, data on urea will be used for read-across. The highest quality repeat dose study available is a 12-month carcinogenicity screening assay with urea, in which F-344 rats and C57BL/6 mice (50/sex/group) were exposed to urea in the diet at concentrations of 4500, 9000 or 45000 ppm for 12 months. No biologically significant effects attributable to the test substance were seen and therefore the NOAEL was deemed to be 45000 ppm. As summarized in the USEPA Integrated Risk Information System (IRIS) document on urea (USEPA, 2011), the approximate dose levels from this study were calculated to be 0, 379, 757, or 3,786 mg/kg-day for male F344 rats; 0, 419, 838, or 4,191 mg/kg-day for F344 females; 0, 644, 1,288, or 6,442 mg/kg-day for male C57BL/6 mice; and 0, 655, 1,311, or 6,553 mg/kg-day for C57BL/6 females. For purposes of derivation of the DNEL, the lowest No Observable Adverse Effect Level (NOAEL) from the one-year study of 3786 mg/kg/day for male rats will be used. Because no repeat dose dermal or inhalation studies are available, route-to-route extrapolation from the oral NOAEL will be utilised. No data are available on the bioavailability of the test substance in rats versus humans for the oral route of administration. The default situation, in the absence of information, is to assume the same bioavailability for experimental animals and humans for a particular exposure route. For route-to-route extrapolation from an oral dose to an inhalation dose the starting point needs to be modified to correct for the breathing volume of the rat and respiratory volume under standard conditions (6.7 m3/person) versus under conditions of light activity for workers (10 m3/person). Based on the European Chemicals Agency's (ECHA) recommendations, it is assumed that respiratory absorption is equivalent between the animals and humans. Therefore, the inhalation starting dose = oral NOAEL (rat) x 1/(0.38 m3/kg/day) x 6.7m3/10m3. In addition, ECHA recommends in the absence of route-specific information on the starting route, to include a default factor of 2 (i.e., the absorption percentage for the starting route is half that of the end route) in the case of oral-to-inhalation extrapolation. Therefore, the inhalation starting dose for the worker population = 3786 mg/kg/day x 1/(0.38 m3/kg/day) x 6.7m3/10m3 x 0.5 = 3338 mg/m3. For route-to-route extrapolation for the dermal route, the absorption differences between the animal and human need to be considered for both the dermal and oral routes. The default situation, in the absence of information, is to assume the same bioavailability for experimental animals and humans for a particular exposure route. In addition, it will be assumed that dermal absorption will not be higher than oral absorption. Therefore, the starting dose for calculation of the dermal DNEL is 3786 mg /kg/day. The assessment factor (AF) for interspecies variability includes an allometric scaling (AS) factor plus an additional factor of 2.5. In the case of the rat, the ECHA recommended AS factor is 4. So the interspecies AF is equal to 4 x 2.5 = 10. However, for the inhalation route, an AS factor is not used. Therefore, for inhalation, only an interspecies factor of 2.5 is used. ECHA (2010) recommends an AF of 5 for intraspecies variability in workers. In accordance with ECHA’s guidelines (2010), a sub-chronic study usually refers to a study of 90 days in length and a chronic study is one that is 1.5 to 2 years. As the key study is a one-year study, for purposes of derivation of a DNEL, it will be assumed that it is a sub-chronic study. The AF for extrapolation from a subchronic toxicity study to a chronic is 2. The total AF used to derive the systemic DNELlong-term for the inhalation route for the worker is 25 (2.5 x 5 x 2). The total AF used to derive the systemic DNEL long-term for the dermal route for the worker is 100 (10 x 5 x 2). Worker DNELlong-term for the inhalation route = 3338/25 = 134 mg /m3. Worker DNELlong-term for the dermal route = 3786/100 = 38 mg /kg/day.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 19 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 786 mg/kg bw/day
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA Guidance
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- ECHA Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA Guidance
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 19 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 786 mg/kg bw/day
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA Guidance
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- ECHA Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA Guidance
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
The most relevant route of potential exposure for potassium allophonate to the general population is the dermal and oral routes. Based on the available acute toxicity data (oral, dermal, inhalation), potassium allophonate is not likely an acute toxicant and, therefore, derivation of Derived No Effect Level (DNEL) for long-term exposures (DNELlong-term) will be sufficient to control potential risks associated with short-term exposures. In addition, based on the available data, potassium allophonate is not likely irritating to either the eyes or skin, or sensitising to the skin. Therefore, based on the available data, potassium allophonate does not appear to elicit local toxicity effects. As such, derivation of a DNEL for local effects is not necessary. Therefore, only a long-term DNEL will be derived for potassium allophonate. Based on the paucity of repeat dose toxicity data available specifically on potassium allophonate, data on urea will be used for read-across. The highest quality repeat dose study available is a 12 -month carcinogenicity screening assay in which F-344 rats and C57BL/6 mice (50/sex/group) were exposed to urea in the diet at concentrations of 4500, 9000 or 45000 ppm for 12 months. No biologically significant effects attributable to the test substance were seen and therefore the No Observable Adverse Effect Level (NOAEL) was deemed to be 45000 ppm. As summarized in the USEPA Integrated Risk Information System (IRIS) document on urea (USEPA, 2011), the approximate dose levels from this study were calculated to be 0, 379, 757, or 3,786 mg/kg-day for male F344 rats; 0, 419, 838, or 4,191 mg/kg-day for F344 females; 0, 644, 1,288, or 6,442 mg/kg-day for male C57BL/6 mice; and 0, 655, 1,311, or 6,553 mg/kg-day for C57BL/6 females. For purposes of derivation of the DNEL, the lowest NOAEL from the one-year study of 3786 mg/kg/day for male rats will be used. The assessment factor (AF) for interspecies variability includes an allometric scaling (AS) factor plus an additional factor of 2.5. In the case of the rat, the European Chemicals Agency (ECHA)-recommended AS factor is 4. So, the interspecies AF is equal to 4 x 2.5 = 10. The ECHA Guidance (2010) recommends an AF of 10 for intraspecies variability in the general population. In accordance with ECHA’s guidelines (2010), a sub-chronic study usually refers to a study of 90 days in length and a chronic study is one that is 1.5 to 2 years. As the key study is a one-year study, for purposes of derivation of a DNEL, it will be assumed that it is a sub-chronic study. The AF for extrapolation from a subchronic toxicity study to a chronic is 2. The total AF used to derive the systemic DNELlong-term for the dermal and oral routes for the general population is 200 (10 x 10 x 2). General population DNELlong-term for the oral/dermal routes = 3786/200 = 19 mg/kg bw/day.
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.
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