Registration Dossier
Registration Dossier
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EC number: 206-059-0 | CAS number: 298-14-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Discussion
Absence of intrinsic systemic toxicity of potassium hydrogencarbonate is generally taken for granted, which is proved by its long-standing safe use in food and pharmaceuticals and its GRAS (generally recognized as safe) status in the. In accordance with the European Parliament and Council Directive No 95/2/EC, potassium hydrogencarbonate (E 501 ii) may be added to almost all foodstuffs - including foodstuffs for infants and children - following the quantum satis principle. This means that no maximum level is specified. However, potassium hydrogencarbonate shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose. Also according to JECFA (Joint FAO/WHO Expert Committee on Food Additives) Potassium hydrogencarbonate (501(ii)) has the ADI evaluation "not limited" and may therefore be used in food stuffs with no limitations other than current good manufacturing practice (Codex Alimentarius specification INS number 501 (ii)).
Further on, according to the results of reliable, adequate and relevant skin and eye irritation studies and an acute inhalation study, potassium hydrogencarbonate is considered as not irritating to the skin, eyes and the respiration tract.
Acute exposure
Acute / short-term DNELs - systemic effects dermal and inhalation
DNELs for acute/short-term, dermal and inhalative exposure will not be derived for the following reasons:
- According to chapter R8 of the ECHA “Guidance on information requirements and chemical safety assessment” a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to classification and labelling) has been identified. Potassium hydrogencarbonate is not classified regarding acute dermal or inhalative toxicity.
- According to chapter R8 of the ECHA “Guidance on information requirements and chemicalsafety assessment” a DNEL for acute toxicity should be derived if there is a potential for high peak exposures, for instance when sampling or connecting/disconnecting vessels. This is not the case for potassium hydrogencarbonate. High peak exposures do not occur during the manufacturing or use.
Acute / short-term exposure - local effects dermal
A DNEL for local effects dermal is not established because no irritation hazard (leading to classification and labelling) has been identified.
Acute / short-term exposure - local effects inhalation
A DNEL for local effects inhalation is not established because no irritation hazard to the respiration tract has been identified.
Long-term exposure
Long-term DNELs - systemic effects dermal and inhalation
As potassium hydrogencarbonate is not expected to display any negative health effects under normal handling and use conditions and in addition exhibits no systemic toxicity after oral exposure, there is no need to set a Long-term DNELs dermal or inhalative for systemic effects.
Long-term DNEL - local effect dermal and inhalation
No DNEL long-term exposure - local effects dermal or inhalation could be derived as no reliable dose descriptors were available for those routes of exposure. However, from the long-standing safe use of potassium hydrogencarbonate there are no indications on local effects. Thus, there is no need to set a Long-term DNELs dermal or inhalative for local effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Discussion
Absence of intrinsic systemic toxicity of potassium hydrogencarbonate is generally taken for granted, which is proved by its long-standing safe use in food and pharmaceuticals and its GRAS (generally recognized as safe) status in the. In accordance with the European Parliament and Council Directive No 95/2/EC, potassium hydrogencarbonate (E 501 ii) may be added to almost all foodstuffs - including foodstuffs for infants and children - following the quantum satis principle. This means that no maximum level is specified. However, potassium hydrogencarbonate shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose. Also according to JECFA (Joint FAO/WHO Expert Committee on Food Additives) Potassium hydrogencarbonate (501(ii)) has the ADI evaluation "not limited" and may therefore be used in food stuffs with no limitations other than current good manufacturing practice (Codex Alimentarius specification INS number 501 (ii)).
Further on, according to the results of reliable, adequate and relevant skin and eye irritation studies and an acute inhalation study, potassium hydrogencarbonate is considered as not irritating to the skin, eyes and the respiration tract.
Acute exposure
Acute / short-term DNELs - systemic effects dermal and inhalation
DNELs for acute/short-term, dermal and inhalative exposure will not be derived for the following reasons:
- According to chapter R8 of the ECHA “Guidance on information requirements and chemical safety assessment” a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to classification and labelling) has been identified. Potassium hydrogencarbonate is not classified regarding acute dermal or inhalative toxicity.
- According to chapter R8 of the ECHA “Guidance on information requirements and chemicalsafety assessment” a DNEL for acute toxicity should be derived if there is a potential for high peak exposures, for instance when sampling or connecting/disconnecting vessels. This is not the case for potassium hydrogencarbonate. High peak exposures do not occur during the manufacturing or use.
Acute /short-term DNELs – systemic effects oral
A DNEL for acute/short-term, oral exposure will not be derived for the following reasons:
- According to chapter R8 of the ECHA “Guidance on information requirements and chemical safety assessment” a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified. Potassium hydrogencarbonate is not classified regarding acute oral toxicity.
- According to chapter R8 of the ECHA “Guidance on information requirements and chemical safety assessment” a DNEL for acute toxicity should be derived if there is a potential for high peak exposures. This is not the case for potassium hydrogencarbonate. High peak exposures do not occur during appropriate technical use. High peak exposure via intentional addition to foodstuffs or pharmaceuticals is regulated by the corresponding directives, e.g. the use as food additive E 501 ii by the European Parliament and Council Directive No 95/2/EC.
Acute / short-term exposure - local effects dermal
A DNEL for local effects dermal is not established because no irritation hazard (leading to classification and labelling) has been identified.
Acute / short-term exposure - local effects inhalation
A DNEL for local effects dermal is not established because no irritation hazard to the respiration tract has been identified.
Long-term exposure
Long-term DNELs - systemic effects dermal and inhalation
As potassium hydrogencarbonate is not expected to display any negative health effect under normal handling and use conditions and in addition exhibits no systemic toxicity after oral exposure, there is no need to set a Long-term DNELs dermal or inhalative for systemic effects.
Long-term DNEL – systemic effects oral
Based on the results of reliable repeated dose toxicity studies on potassium hydrogencarbonate, the approved use of potassium hydrogencarbonate in pharmaceutical preparations and foodstuffs with no specific quantity restriction except of the quantum satis principle and the nutritional essentiality of potassium as well as the essential role of carbonate in the body, potassium hydrogencarbonate can be judged as systemically non-toxic. Thus, there is no need to set DNELs for systemic repeated dose toxicity.
Long-term DNEL - local effect dermal and inhalation
No DNEL long-term exposure - local effects dermal or inhalation could be derived as no reliable dose descriptors were available for those routes of exposure. However, from the long-standing safe use of potassium hydrogencarbonate there are no indications on local effects. Thus, there is no need to set a Long-term DNELs dermal or inhalative for local effects.
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