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EC number: 234-746-5 | CAS number: 12030-88-5
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
No reproductive or developmental toxicity studies with potassium superoxide are available. The summary only provides evidence from the degradation product hydrogen peroxide. Overall, due to rapid in vivo degradation of KO2, no toxicity to the reproductive system is anticipated. Also, in practice, exposure of workers and consumers to KO2 is not expected and is completely confined to closed containers or articles. Therefore, reproductive-developmental toxicity of KO2 is expected to be of low concern.
No significant exposure occurs at the level of industrial/professional handling: KO2 is not manufactured in the EU. The substance is imported in the form of low dust tablets which are sealed and packed. Upon opening and before use, dust reduction measures are taken to avoid exposure via inhalation. The tablets are transferred from the barrels/bags into cartridges that are integrated into sealed Oxygen Self Rescuer units.
No significant exposure occurs at the level of consumer use: The self-rescuer device serves as a rescue device in emergency situations e.g. in mines or aircrafts. The user puts on the device and breathes through a mouthpiece and breathing tube. The moisture and CO2 from the breath react with KO2 to generate oxygen, potassium hydroxide and potassium carbonate in the cartridge. Due to the specific design of the device, the user is protected from any contact with KO2 or inhaling KO2 dust. When spent, the cartridges are sent back for recycling or waste incineration. Unused devices are disposed of in a similar way.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Justification for type of information:
- Refer to the section 13 for details on the read across justification. The toxicity to reproduction study with the degradation product is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
- Principles of method if other than guideline:
- Reproductive toxicity study in rats
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Route of administration:
- oral: drinking water
- Details on exposure:
- 0.45% test substance in drinking water (ad lib.)
- Duration of treatment / exposure:
- Exposure period: 5 months (females), 9 months (male offspring)
Premating exposure period (males): 5 months
Premating exposure period (females): 5 months
Duration of test: ca. 14 months - Frequency of treatment:
- Daily
- Dose / conc.:
- 0.45 other: %
- Remarks:
- in drinking water
- Control animals:
- yes, concurrent vehicle
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 0.45 other: %
- Based on:
- test mat. (dissolved fraction)
- Sex:
- female
- Basis for effect level:
- other: no treatment-related adverse effect
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight for male offspring on H2O2 is lower than those on tap water
Difference in body weight of the six male offspring followed for 9 months (an average of 521g for those on tap water against 411g for those on the test substance). - Key result
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 0.45 other: %
- Based on:
- test mat. (dissolved fraction)
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effect except decrease in body weight
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Under the study conditions, long term administration of the substance did not affect reporduction in female rats.
- Executive summary:
A study was conducted to determine the potential reproductive toxicity of the degradation product hydrogen peroxide in female rats. The substance was admnistered to the rats through drinking water at 0.45% for 5 months and mated with normal males. Upon production of normal litters, they were maintained under the treated drinking water for nine months. The only noticeable effect observed was a difference in body weight of the male offsprings which they gained after they were given normal water. Under the study conditions, long term administration of the substance did not affect reporduction in female rats at 0.45% of the substance (Hankin, 1958).
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- other: evidence based on degradation product
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Justification for type of information:
- Justification for type of information: Refer to the section 13 for details. The toxicity to reproduction study with the degradation product is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
- Principles of method if other than guideline:
- Male reproductive toxicity study
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male
- Route of administration:
- oral: drinking water
- Duration of treatment / exposure:
- Exposure period: 7, 21 or 28 days
Premating exposure period (males): 7, 21 or 28 days - Frequency of treatment:
- Daily
- Details on study schedule:
- Exposure period: 7, 21 or 28 days
Premating exposure period (males): 7, 21 or 28 days - Dose / conc.:
- 0 other: %
- Remarks:
- in drinking water
- Dose / conc.:
- 0.33 other: %
- Remarks:
- in drinking water
- Dose / conc.:
- 1 other: %
- Remarks:
- in drinking water
- Dose / conc.:
- 3 other: %
- Remarks:
- in drinking water
- No. of animals per sex per dose:
- 12 males per dose
- Control animals:
- no
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 0.33 other: %
- Based on:
- test mat. (dissolved fraction)
- Sex:
- male
- Basis for effect level:
- other: no treatment-related adverse effects except body weight gain
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 3 other: %
- Based on:
- test mat. (dissolved fraction)
- Sex:
- male/female
- Basis for effect level:
- other: no treatment-related adverse effect
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Under the study conditions, the substance had no significant effects on the reproductive capacity of male mice.
- Executive summary:
A study was conducted to determine the potential reprotoxicity of the degradation product hydrogen peroxide. Male mice were administered the substance in drinking water at 0, 0.33, 1 and 3% for 7, 21 or 28 days before the mating period and then mated with normal females. The test substance treatment continued through the mating period. All female mice mated to treated males became pregnant within a few days and in each case healthy pups were born in litters of normal size. Pregnant mice that continued to consume 1% test substance in water until near term showed some delays in parturition compared to dams consuming untreated tap water, although the effect was small and inconsistent. The concentration, morphology and motility of the mouse spermatozoa after 3 weeks of treatment appeared normal. Under the study conditions, the substance had no significant effects on the reproductive capacity of male mice (Wales, 1959).
Referenceopen allclose all
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Evidence based on the studies with the degradation product hydrogen peroxide:
A study was conducted to determine the potential reproductive toxicity of the degradation product hydrogen peroxide in female rats. The substance was admnistered to the rats through drinking water at 0.45% for 5 months and mated with normal males. Upon production of normal litters, they were maintained under the treated drinking water for nine months. The only noticeable effect observed was a difference in body weight of the male offsprings which they gained after they were given normal water. Under the study conditions, long term administration of the substance did not affect reporduction in female rats at 0.45% of the substance (Hankin, 1958).
A study was conducted to determine the potential reprotoxicity of the degradation product hydrogen peroxide. Male mice were administered the substance in drinking water at 0, 0.33, 1 and 3% for 7, 21 or 28 days before the mating period and then mated with normal females. The test substance treatment continued through the mating period. All female mice mated to treated males became pregnant within a few days and in each case healthy pups were born in litters of normal size. Pregnant mice that continued to consume 1% test substance in water until near term showed some delays in parturition compared to dams consuming untreated tap water, although the effect was small and inconsistent. The concentration, morphology and motility of the mouse spermatozoa after 3 weeks of treatment appeared normal. Under the study conditions, the substance had no significant effects on the reproductive capacity of male mice (Wales, 1959).
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
In vivo, potassium superoxide reacts rapidly with water to produce potassium hydroxide (KOH), oxygen (O2) and potassium hydrogen peroxide (KHO2), which slowly degrades to KOH, H2O2 (hydrogen peroxide) and O2. KOH further dissociates into potassium and hydroxyl ions which constitute normal physiological ion pool. On the other hand, hydrogen peroxide is likely to degrade within a short time in in vivo conditions due to many alternative and competitive degradation pathways. Especially, in alkaline medium and in the presence of heavy and transition metals it is degraded rapidly.
No appropriate animal studies were available for a complete evaluation of reproductive and developmental toxicity with H2O2. Two limited studies with mice and rats exposed to hydrogen peroxide in drinking water suggested no grave disturbances on the male or female reproductive functions (Wales et al., 1959; Hankin, 1958).
Thus there is a clear data gap regarding studies of developmental toxicity for hydrogen peroxide. Industry had however requested a derogation for reproductive toxicity screening which was consented at the Technical Meeting level. The decision was reached on the presumption that conventional study protocols (e.g. administration in drinking water) were unlikely to show specific embryonal or foetal effects firstly, because it is doubtful whether hydrogen peroxide (as opposed to its degradation products oxygen and water) would reach the foetus and secondly, because local effects in the mother, possibly causing nutritional disturbances and general toxicity, are expected (European Chemicals Bureau, 2003).
No significant exposure occurs at the level of industrial/professional handling or consumer use. In practice, KO2 is completely confined to closed containers or articles and hence not expected to come in contact with humans during normal use conditions.
Therefore, overall considering the in vivo degradation of KO2 and inaccessibility to human beings under normal use conditions, reproductive toxicity of KO2 is expected to be of low concern.
Justification for classification or non-classification
Based on the information presented above, potassium superoxide does not warrant classification for reproductive toxicity according to EU CLP (1272/2008) criteria.
Additional information
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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