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EC number: 209-529-3 | CAS number: 584-08-7
- 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
Reliable data from a Buehler sensitisation study according to US EPA/FIFRA Guideline in guinea pigs are available. There was no evidence for a skin sensitisation after challenge with 95 % of potassium carbonate. The sensitisation rate was 0 %.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-02-03 to 1993-03-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Guinea Pig Sensitization (Buehler)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A valid Buehler test conducted comparable to guideline with acceptable restrictions is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, New Jersey
- Age at study initiation: no data in study summary
- Weight at study initiation: 357 - 446 g
- Housing: no data in study summary
- Diet (e.g. ad libitum): no data in study summary
- Water (e.g. ad libitum): no data in study summary
- Acclimation period: no data in study summary
ENVIRONMENTAL CONDITIONS
- no data in study summary - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 95 % for induction and challenge. To enhance skin contact, the substance was moistened with water (95% w/w).
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 95 % for induction and challenge. To enhance skin contact, the substance was moistened with water (95% w/w).
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- test group: 10 animals
negative control group: 5 animals
positive control group: 10 animals
negative control for positive control group: 5 animals - Details on study design:
- After establishing the minimum irritating concentration (MIC) and the highest non-irritating concentration (HNIC) to be a 95 % w/w mixture in
distilled water, a 3 week induction period was initiated during which 10 young adult guinea pigs were treated with the test substance at its MIC
and 10 positive control animals were treated with Dinitrochlorobenzene (DNCS) at its MIC (0.08 % in 80 % aqueous ethanol). During the induction
period the animals were dosed once each week for three weeks. Fourteen days after the third induction a challenge dose was applied at the
respective test and positive control HNIC to a naive site on each group of guinea pigs. Approximately 24 and 48 hours later the animals were
scored for a sensitization response (erythema). - Challenge controls:
- Two naive control groups of (5 animals for the test material and five for the positive control) were maintained under the same environmental
conditions and treated with the test or control substance at challenge only. - Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene (DNCB)
- Positive control results:
- 24 hours after challenge, 8 of 10 positive control sites exhibited signs of a sensitization response including faint to moderate erythema. These indications persisted at all sites through 48 hours.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 95 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 95 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 95 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 95 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.08 % in 80 % aqueous ethanol
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, the test article "Biocide #5654, Potassium Carbonate" is not a dermal sensitizer.
- Executive summary:
In a dermal sensitization study according to US EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Guinea Pig Sensitization (Buehler) with the test article "Biocide #5654, Potassium Carbonate" in water, young adult Hartley guinea pigs (10 test and 5 control animals) were tested using the method of Buehler. Positive control substance was Dinitrochlorobenzene (DNCB) with a sensitisation rate of 80 % (10 test and 5 control animals).
To enhance skin contact, the substance was moistened with water (95% w/w) for induction and challenge exposure. No irritation was noted at any of the test or negative control sites during the induction phase. After challenge exposure no skin reactions were observed in test or control animals at any observation time. Therefore, the sensitisation rate was 0 %.
In this study, the test article "Biocide #5654, Potassium Carbonate" is not a dermal sensitizer.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
As expected, there is no evidence for a skin sensitisation from a Buehler sensitisation study. The abiotic dissociation of potassium carbonate with tissue water results in the formation of potassium and carbonate ions. Potassium and carbonate ions are naturally occurring, effectively processed and regulated essential compounds in the body. K+or CO32- resulting from the ionisation (dissociation) of K2CO3 will not influence the natural K+or CO32- level in the body due to the natural regulation mechanisms.and for this reason it is very unlikely that potassium carbonate has an intrinsic sensitising activity. The absence of intrinsic toxic properties of potassium carbonate is generally taken for granted, which is proved by its long-standing safe use in foodstuffs and pharmaceuticals with no limitations other than current good manufacturing practice and its GRAS (generally recognized as safe) status in the USA.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No study available. However, based on the structure of potassium carbonate, no sensitising effects are expected. The abiotic dissociation of potassium carbonate with tissue water results in the formation of potassium and carbonate ions. Potassium and carbonate ions are naturally occurring, effectively processed and regulated essential compounds in the body and for this reason it is very unlikely that they could cause respiratory sensitisation. Absence of intrinsic toxic properties of potassium carbonate is generally taken for granted, which is proved by its long-standing safe use in foodstuffs and pharmaceuticals with no limitations other than current good manufacturing practice and its GRAS (generally recognized as safe) status in the USA.
Justification for classification or non-classification
Data from a Buehler study with guinea pigs indicate that potassium carbonate does not induce skin sensitisation. Further on, based on the structure of potassium carbonate, no sensitising effects are expected.
According to GHS Regulation (EC) No 1272/2008 potassium carbonate is not classified as “sensitising” and labelling is not required.
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