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EC number: 235-227-6 | CAS number: 12136-45-7
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: Published data
- 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:
- According to the SIDS document for potassium hydroxide (30 January 2002), a Klimisch score of 2 was assigned since test procedure is in accordance with national standard methods with acceptable restrictions. When Potassium oxide is hydrated is produced Potassium hydroxide. Therefore, the health effects of Potassium hydroxide need to be considered in the assessment of Potassium oxide.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- repeated insult test : similar to test described by Landsteiner and Jacobs (1935)
the test substance was injected intracutaneously to separate skin sites of the animals (3x weekly, in total 9 threatments)
Two weeks after the last injection, a challenge dose (0.1ml) was administered (test and control animals).
Skin reactions were examined at 24, 48 and 72 hr following the challenge dose. - GLP compliance:
- no
- Type of study:
- intracutaneous test
- Justification for non-LLNA method:
- repeated insult test : similar to test described by Landsteiner and Jacobs (1935)
the test substance was injected intracutaneously to separate skin sites of the animals (3x weekly, in total 9 threatments)
Two weeks after the last injection, a challenge dose (0.1ml) was administered (test and control animals).
Skin reactions were examined at 24, 48 and 72 hr following the challenge dose. - Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300-400 g - Route:
- other: intracutaneous
- Vehicle:
- water
- Concentration / amount:
- Concentrations used for induction: 0.1%
- Route:
- other: intracutaneous
- Vehicle:
- water
- Concentration / amount:
- Concentrations used for induction: 0.1%
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 3 weeks
- Test groups: 5 males
- Control group: 10 males
- Frequency of applications: 3 times weekly
- Concentrations: 0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Test groups: 5 males
- Control group: 10 males
- Concentrations: 0.1%
- Evaluation (hr after challenge): 24, 48 and 72h
OTHER: non-adjuvent study type - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- not sensitizing
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: not sensitizing.
- Interpretation of results:
- other: not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Potassium Hydroxide (0.1%) does not induce cutaneous sensitization in guinea pigs
When Potassium oxide is hydrated is produced Potassium hydroxide. Therefore, the health effects of Potassium hydroxide need to be considered in the assessment of Potassium oxide. - Executive summary:
Potassium Hydroxide (0.1%) does not induce cutaneous sensitization in guinea pigs
When Potassium oxide is hydrated is produced Potassium hydroxide. Therefore, the health effects of Potassium hydroxide need to be considered in the assessment of Potassium oxide.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation
When Potassium oxide is hydrated is produced Potassium hydroxide. Therefore, the health effects of Potassium hydroxide need to be considered in the assessment of Potassium oxide.
No evidence of sensitisation in the study of Johnson GT et al.1975.The test substance (Potassium hydroxide as a surrogate for Potassium oxide) is not sensitising to skin.
Potassium Hydroxide (0.1%) does not induce cutaneous sensitization in guinea pigs. This result can be reliably be read across to the substance Potassium oxide l (CAS# 12136-45-7 )
Synopsis
Not sensitising
Migrated from Short description of key information:
No evidence of skin sensitisation. It is concluded that the substance Potassium oxide/Dipotassium oxide does not meet the criteria to be classified for human health hazards for Inhalation - local effect: skin sensitisation.
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation: in chemico
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Respiratory sensitisation.
There are no Respiratory sensitisationstudies available.
Due to the absence of chemical groups or other structural alerts this substance is not considered to exhibit an high hazard potential.
Potassium oxide is of low priority for further work based on a low hazard potential.is of low priority for further work based on a low hazard potential.
Synopsis
Not Sensitising
Migrated from Short description of key information:
There are no Respiratory sensitisation studies available.
Due to the absence of chemical groups or other structural alerts this substance is not considered to exhibit an high hazard potential.
Potassium oxide is of low priority for further work based on a low hazard potential.is of low priority for further work based on a low hazard potential.
Therefore testing for Respiratory sensitisation does not need to be performed.
Justification for classification or non-classification
Based on the hazard assessment of Potassium oxide/Dipotassium oxide section 2.1 and 2.2. in IUCLID 5.4., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Respiratory Sensitisation Xn R42 May cause sensitization by inhalation Respiratory Irritation Xi R37 irritating to respiratory system |
CLP |
Respiratory Sensitisation H334 Resp. Sens. 1 May cause allergy or asthma symptoms or breath-ing difficulties if inhaled Respiratory Irritation H335 STOT SE 3 May cause respiratory irritation |
It is concluded that the substance Potassium oxide/Dipotassium oxide does notmeet the criteria to be classified for human health hazards for Inhalation - local effect: respiratory sensitisation.
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