Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 209-529-3 | CAS number: 584-08-7
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:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
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 C&L) has been identified. Potassium carbonate is not classified regarding acute dermal or inhalative 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, for instance when sampling or connecting/disconnecting vessels. This is not the case for potassium carbonate. High peak exposures do not occur during the manufacturing or use.
Acute / short-term exposure - local effects dermal
No irritation was induced by undiluted potassium carbonate applied to the skin and moistened with saline in tests performed for twenty four hours under occlusive conditions with rabbits. Slight irritating effects observed in humans after accidental exposure were fully reversible. Based upon these considerations, no DNEL for local dermal effects in workers is derived.
Potassium carbonate has an intrinsic irritating activity especially to eyes and is classified accordingly so that there is no need to derive a DNEL for eye exposure since for handling the respective risk management measures (RMMs) are implemented and a contact to the eyes has to be avoided. The activity of potassium carbonate is solely based on alkalinity. In mixtures, the acid reserve of the additional compounds of the mixtures may compensate the alkalinity of potassium carbonate and thus its irritancy. Therefore, with reference to CLP Regulation (EC) No 1272/2008, Annex I, 3.2.3.1.2, for classification of potassium carbonate in mixtures it is justified to take the acid reserve of the mixture into account.
Acute / short-term exposure - local effects inhalation
The derived DNEL "Long-term exposure - local effects inhalation" is considered to be also protective against local effects by short-term exposure, as peak-exposure effects were taken into account in DNEL derivation.
Long-term exposure
Long-term DNELs - systemic effects dermal and inhalation
As potassium carbonate 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 - local effect dermal
The substance is classified as Skin Irritation Category 2, Eye Irritation category 2, and STOT SE 3 (respiratory irritation). Thus, according to the Guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation, the substance is of medium hazard.
Long-term DNEL - local effect inhalation
A long-term DNEL (inhalation) for local irritating effects will be set, as in a supporting long-term inhalation study on a potassium carbonate based used scrubbing solution, a local respiratory tract irritation was evident in the experimental animals. However, the study on the potassium carbonate based scrubbing solution is judged as reliable supporting information but not as adequate for DNEL derivation, since confounding effects of components other than potassium carbonate of the used scrubbing solution have to be considered.
Based on the generic irritation threshold as evaluated in the publication “An approach for the delineation of a generic cut-off value for local respiratory tract irritation by irritating or corrosive substances as a pragmatic tool to fulfill REACH requirements” (Messinger H, 2014. Regulatory Toxicology and Pharmacology 68 (2014) 317–324), the inhalation DNEL (local effects) was set at 10 mg/m³. The author evaluated existing occupational exposure limits (OEL) as surrogate for cut-off limits representing safe exposure under working conditions for substances, which are legally classified as irritating or corrosive. As a result, it was shown that the OEL for irritating substances or substances classified as Category 1 for Eye Damage in this dataset is not lower than 10 mg/m³ and for corrosives not lower than 1 mg/m³. These generic limits can be applied as a pragmatic, but still sufficiently reliable and protective upper cut-off limit approach. Further assessment factors to account for intra- and interspecies differences are not necessary since these were already taken into account when deriving the respective threshold limit values. This model is applicable to substances, which are not classified as CMR, not sensisiting, and not very toxic by ingestion, dermal contact, or inhalation. Potassium carbonate falls into this applicability domain.
In conclusion, the DNEL for potassium carbonate for long-term inhalation, workers is 10.0 mg/m³. There is no evidence, that a lower DNEL would be required for potassium carbonate.
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- medium hazard (no threshold derived)
Additional information - General Population
Acute exposure
Acute /short-term DNELs – systemic effects dermal and inhalation
DNEL 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 C&L) has been identified. Potassium carbonate is not classified regarding acute dermal or inhalative 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 carbonate. High peak exposures do not occur during appropriate 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 carbonate 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 carbonate. High peak exposures are not to be expected for the general population. 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 i by the European Parliament and Council Directive No 95/2/EC.
Acute / short-term exposure - local effects dermal
No irritation was induced by undiluted potassium carbonate applied to the skin and moistened with saline in tests performed for twenty four hours under occlusive conditions with rabbits. Slight irritating effects observed in humans after accidental exposure were fully reversible. Further on, it is highly unlikely that the general population will be dermally exposed to potassium carbonate. Based upon these considerations the DNEL is dispensable due to exposure considerations.
Potassium carbonate has an intrinsic irritating activity and is classified accordingly. The activity of potassium carbonate is solely based on alkalinity. In mixtures (= consumer products) the acid reserve of the additional compounds of the mixtures may compensate the alkalinity of potassium carbonate and thus its irritancy. Therefore, with reference to CLP Regulation (EC) No 1272/2008, Annex I, 3.2.3.1.2, for classification of potassium carbonate in mixtures it is justified to take the acid reserve of the mixture into account.
Further on, it is highly unlikely that the general population will be exposed to potassium carbonate by inhalation. Based upon these considerations the DNEL is dispensable due to exposure considerations.
Long-term exposure
Long-term DNELs - systemic effects dermal and inhalation
As potassium carbonate is not expected to display any negative health effect in the body under normal handling and use conditions and in addition exhibits no systemic toxicity after oral exposure, there is no need to set long-term DNELs dermal or inhalation for systemic effects.
Long-term DNEL – systemic effects oral
Based on the results of reliable repeated dose toxicity studies on the closely related read-across substance potassium hydrogencarbonate, the approved use of potassium carbonate 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 carbonate can be judged as systemically non-toxic. Thus, there is no need to set DNELs for systemic repeated dose toxicity.
Long-term DNEL – local effects dermal
The substance is classified as Skin Irritation Category 2, Eye Irritation category 2, and STOT SE 3 (respiratory irritation). Thus, according to the Guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation, the substance is of medium hazard.
Long-term DNEL – local effects inhalation
The substance is classified as Skin Irritation Category 2, Eye Irritation category 2, and STOT SE 3 (respiratory irritation). Thus, according to the Guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation, the substance is of medium hazard.
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.
