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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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Nanomaterial specific surface area
- Nanomaterial Zeta potential
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- Nanomaterial pour density
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- Endpoint summary
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- 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
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- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- 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

Carcinogenicity
Administrative data
Description of key information
Valid carcinogenicity studies with animals are not available for potassium oxide.
Potassium chloride (KCl) is the most common source of Potassium oxide (K2O).Therefore, the health effects of potassium chloride need to be considered in the assessment of Potassium oxide
In a long term study (Imai 1961, UNEP 2003) performed with KCl, no carcinogenic effects were observed in male rats, Groups of 50 male F344/Slc rats were fed KCl in the diet at levels of 110, 450, 1820 mg/kg bw/day for 2 years. A comprehensive examination of the tissue revealed no evidence of treatment related carcinogenicity. Among non-tumerous lesions nephrotic lesion was predominant in all treatment groups as well as in the control group. In tumerous lesions testicular tumour (interstititial cell tumour) developed with a high incidence in all groups. However, the incidence and type of tumour in experimental and control groups were comparable to those of sponateous tumours in the test organism.
There is no reason to believe that Potassium chloride as a read across for Potassium oxide has carcinogenic potential.
NOAEL: 1820 mg/kg bw/day
The NOAEL is the highest tested dose.
There are conclusive but not suffcient data for the classification of substance Potassium oxide with regard to carcinogenicity.
Carcinogenicity: IARC, NTP, ACGIH and OSHA do not classify this substance or its components as a carcinogen or suspect carcinog
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- 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
- Principles of method if other than guideline:
- Groups of male F344/Slc rats received different doses of KCl in feed over a period of 2 years and were observed for clinical signs and mortality and were examined for gross and histopathological changes at the end of the treatment period
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- other: F344/Slc
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no information given
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Groups of male F344/Slc rats received different doses of KCl in feed over a period of 2 years and were observed for clinical signs and mortality and were examined for gross and histopathological changes at the end of the treatment period
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily
- Post exposure period:
- no
- Remarks:
- Doses / Concentrations:
0, 0.25, 1, 5 % in diet (corresponding to 0, 110, 450, 1820 mg/kg bw/day
Basis:
nominal in diet - No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Groups of male F344/Slc rats received different doses of KCl in feed over a period of 2 years and were observed for clinical signs and mortality and were examined for gross and histopathological changes at the end of the treatment period
- Positive control:
- no
- Observations and examinations performed and frequency:
- survival, food consumption, blood pressure, body weight development
urinalysis: protein, glucose, keton, bilirubin, urobilinogen, pH
hematology: RBC, HB, Ht, MCV, HCH, MCHC, Pt, WBC
biochemical analysis: GOT, GPT, ALP, LDH, Ch-E, Na, K, Cl, Nu, Clu, Tp, Glu - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
absolue and relative organ weight: brain, pituitary, thymus, heart, right and leftlungs, linver, spleen, pancreas, right and left kidneys, right and leftadernals. right and left testes, seminal vesicles, prostrate
HISTOPATHOLOGY: Yes
heart, lung, liver, kidney, stomach, aorta
(grading of nephrosis +, ++, +++) - Other examinations:
- no data
- Statistics:
- no data
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- MORTALITY:
after termination of the 2 year treatment period_
110, 450, 1820 mg/kg bw/day versus control:
18/50, 21/50, 8/50 versus 26/50
survival rate:
32/50, 29/50, 42/50 versus 24/50
HISTOPATHOLOGY: NON-NEOPLASTIC
KIDNEYS. nephritis
110, 450, 1820 mg/kg bw/day versus control:
32/32, 29/29, 42/42 versus 24/24
grading:
110 mg/kg: 23/32: +; 6/32: ++; 3/32: +++
450 mg/kg: 11/29:+; 6/29: ++; 12/29: +++;
1820 mg/kg: 28/42: +; 13/42: ++; 1/42: +++
control: 14/24: +; 6/24: ++; 4/24: +++
STOMACH.:
110, 450, 1820 mg/kg bw/day versus control:
gastritis
18/32, 18/29; 30/42 versus 6/24
ulcer
0/32, 2/29 , 2/42 versus 0/24
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
HISTORICAL CONTROL DATA (if applicable)
In tumerous lesions, testicular tumor developed with a high incidence in all groups and the incidence of pheochromocytoma in the adrenals was moderately high in all groups.
However the incidence and type of tumour in experimental and control group were comparable to those of spontaneous tumours in F344/Slc rats (data not shown). Therefore the tumours observed in this study were thought to be spontaneous in origin - Dose descriptor:
- other: no treatment related carcinogenic effect
- Effect level:
- >= 110 - <= 1 820 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 820 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: The high mortality in all groups including controls (>50%) . nephritits was reported in all treatment groups as well as in the control group (UNEP 2003)
- Remarks on result:
- other: Effect type: toxicity (migrated information)
- Conclusions:
- In a long term study performed with KCl, no carcinogenic effects were observed in male rats, Groups of 50 male F344/Slc rats were fed KCl in the diet at levels of 110, 450, 1820 mg/kg bw/day for 2 years. A comprehensive examination of the tissue revealed no evidence of treatment related carcinogenicity. Among non-tumerous lesions nephrotic lesion was predominant in all treatment groups as well as in the control group. In tumerous lesions testicular tumour (interstititial cell tumour) developed with a high incidence in all groups. However, the incidence and type of tumour in experimental and control groups were comparable to those of sponateous tumours in the test organism (Imai 1961, UNEP 2003)
- Executive summary:
In a long term study performed with KCl, no carcinogenic effects were observed in male rats, Groups of 50 male F344/Slc rats were fed KCl in the diet at levels of 110, 450, 1820 mg/kg bw/day for 2 years. A comprehensive examination of the tissue revealed no evidence of treatment related carcinogenicity. Among non-tumerous lesions nephrotic lesion was predominant in all treatment groups as well as in the control group. In tumerous lesions testicular tumour (interstititial cell tumour) developed with a high incidence in all groups. However, the incidence and type of tumour in experimental and control groups were comparable to those of sponateous tumours in the test organism (Imai 1961, UNEP 2003)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 820 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Carcinogenicity: via inhalation route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- 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
- Principles of method if other than guideline:
- Groups of male F344/Slc rats received different doses of KCl in feed over a period of 2 years and were observed for clinical signs and mortality and were examined for gross and histopathological changes at the end of the treatment period
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- other: F344/Slc
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no information given
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Groups of male F344/Slc rats received different doses of KCl in feed over a period of 2 years and were observed for clinical signs and mortality and were examined for gross and histopathological changes at the end of the treatment period
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily
- Post exposure period:
- no
- Remarks:
- Doses / Concentrations:
0, 0.25, 1, 5 % in diet (corresponding to 0, 110, 450, 1820 mg/kg bw/day
Basis:
nominal in diet - No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Groups of male F344/Slc rats received different doses of KCl in feed over a period of 2 years and were observed for clinical signs and mortality and were examined for gross and histopathological changes at the end of the treatment period
- Positive control:
- no
- Observations and examinations performed and frequency:
- survival, food consumption, blood pressure, body weight development
urinalysis: protein, glucose, keton, bilirubin, urobilinogen, pH
hematology: RBC, HB, Ht, MCV, HCH, MCHC, Pt, WBC
biochemical analysis: GOT, GPT, ALP, LDH, Ch-E, Na, K, Cl, Nu, Clu, Tp, Glu - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
absolue and relative organ weight: brain, pituitary, thymus, heart, right and leftlungs, linver, spleen, pancreas, right and left kidneys, right and leftadernals. right and left testes, seminal vesicles, prostrate
HISTOPATHOLOGY: Yes
heart, lung, liver, kidney, stomach, aorta
(grading of nephrosis +, ++, +++) - Other examinations:
- no data
- Statistics:
- no data
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- MORTALITY:
after termination of the 2 year treatment period_
110, 450, 1820 mg/kg bw/day versus control:
18/50, 21/50, 8/50 versus 26/50
survival rate:
32/50, 29/50, 42/50 versus 24/50
HISTOPATHOLOGY: NON-NEOPLASTIC
KIDNEYS. nephritis
110, 450, 1820 mg/kg bw/day versus control:
32/32, 29/29, 42/42 versus 24/24
grading:
110 mg/kg: 23/32: +; 6/32: ++; 3/32: +++
450 mg/kg: 11/29:+; 6/29: ++; 12/29: +++;
1820 mg/kg: 28/42: +; 13/42: ++; 1/42: +++
control: 14/24: +; 6/24: ++; 4/24: +++
STOMACH.:
110, 450, 1820 mg/kg bw/day versus control:
gastritis
18/32, 18/29; 30/42 versus 6/24
ulcer
0/32, 2/29 , 2/42 versus 0/24
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
HISTORICAL CONTROL DATA (if applicable)
In tumerous lesions, testicular tumor developed with a high incidence in all groups and the incidence of pheochromocytoma in the adrenals was moderately high in all groups.
However the incidence and type of tumour in experimental and control group were comparable to those of spontaneous tumours in F344/Slc rats (data not shown). Therefore the tumours observed in this study were thought to be spontaneous in origin - Dose descriptor:
- other: no treatment related carcinogenic effect
- Effect level:
- >= 110 - <= 1 820 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 820 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: The high mortality in all groups including controls (>50%) . nephritits was reported in all treatment groups as well as in the control group (UNEP 2003)
- Remarks on result:
- other: Effect type: toxicity (migrated information)
- Conclusions:
- In a long term study performed with KCl, no carcinogenic effects were observed in male rats, Groups of 50 male F344/Slc rats were fed KCl in the diet at levels of 110, 450, 1820 mg/kg bw/day for 2 years. A comprehensive examination of the tissue revealed no evidence of treatment related carcinogenicity. Among non-tumerous lesions nephrotic lesion was predominant in all treatment groups as well as in the control group. In tumerous lesions testicular tumour (interstititial cell tumour) developed with a high incidence in all groups. However, the incidence and type of tumour in experimental and control groups were comparable to those of sponateous tumours in the test organism (Imai 1961, UNEP 2003)
- Executive summary:
In a long term study performed with KCl, no carcinogenic effects were observed in male rats, Groups of 50 male F344/Slc rats were fed KCl in the diet at levels of 110, 450, 1820 mg/kg bw/day for 2 years. A comprehensive examination of the tissue revealed no evidence of treatment related carcinogenicity. Among non-tumerous lesions nephrotic lesion was predominant in all treatment groups as well as in the control group. In tumerous lesions testicular tumour (interstititial cell tumour) developed with a high incidence in all groups. However, the incidence and type of tumour in experimental and control groups were comparable to those of sponateous tumours in the test organism (Imai 1961, UNEP 2003)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 79.13 mg/m³
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- There are no Inhalation Carcinogenic studies available.
The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.
NOAEL rat 1820 mg/kg bw/day
÷1.15m3/kgbw
÷20m3/mice
NOAECrat 79.13mg/m3
Carcinogenicity: via dermal route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- 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
- Principles of method if other than guideline:
- Groups of male F344/Slc rats received different doses of KCl in feed over a period of 2 years and were observed for clinical signs and mortality and were examined for gross and histopathological changes at the end of the treatment period
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- other: F344/Slc
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no information given
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Groups of male F344/Slc rats received different doses of KCl in feed over a period of 2 years and were observed for clinical signs and mortality and were examined for gross and histopathological changes at the end of the treatment period
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily
- Post exposure period:
- no
- Remarks:
- Doses / Concentrations:
0, 0.25, 1, 5 % in diet (corresponding to 0, 110, 450, 1820 mg/kg bw/day
Basis:
nominal in diet - No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Groups of male F344/Slc rats received different doses of KCl in feed over a period of 2 years and were observed for clinical signs and mortality and were examined for gross and histopathological changes at the end of the treatment period
- Positive control:
- no
- Observations and examinations performed and frequency:
- survival, food consumption, blood pressure, body weight development
urinalysis: protein, glucose, keton, bilirubin, urobilinogen, pH
hematology: RBC, HB, Ht, MCV, HCH, MCHC, Pt, WBC
biochemical analysis: GOT, GPT, ALP, LDH, Ch-E, Na, K, Cl, Nu, Clu, Tp, Glu - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
absolue and relative organ weight: brain, pituitary, thymus, heart, right and leftlungs, linver, spleen, pancreas, right and left kidneys, right and leftadernals. right and left testes, seminal vesicles, prostrate
HISTOPATHOLOGY: Yes
heart, lung, liver, kidney, stomach, aorta
(grading of nephrosis +, ++, +++) - Other examinations:
- no data
- Statistics:
- no data
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- MORTALITY:
after termination of the 2 year treatment period_
110, 450, 1820 mg/kg bw/day versus control:
18/50, 21/50, 8/50 versus 26/50
survival rate:
32/50, 29/50, 42/50 versus 24/50
HISTOPATHOLOGY: NON-NEOPLASTIC
KIDNEYS. nephritis
110, 450, 1820 mg/kg bw/day versus control:
32/32, 29/29, 42/42 versus 24/24
grading:
110 mg/kg: 23/32: +; 6/32: ++; 3/32: +++
450 mg/kg: 11/29:+; 6/29: ++; 12/29: +++;
1820 mg/kg: 28/42: +; 13/42: ++; 1/42: +++
control: 14/24: +; 6/24: ++; 4/24: +++
STOMACH.:
110, 450, 1820 mg/kg bw/day versus control:
gastritis
18/32, 18/29; 30/42 versus 6/24
ulcer
0/32, 2/29 , 2/42 versus 0/24
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
HISTORICAL CONTROL DATA (if applicable)
In tumerous lesions, testicular tumor developed with a high incidence in all groups and the incidence of pheochromocytoma in the adrenals was moderately high in all groups.
However the incidence and type of tumour in experimental and control group were comparable to those of spontaneous tumours in F344/Slc rats (data not shown). Therefore the tumours observed in this study were thought to be spontaneous in origin - Dose descriptor:
- other: no treatment related carcinogenic effect
- Effect level:
- >= 110 - <= 1 820 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 820 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: The high mortality in all groups including controls (>50%) . nephritits was reported in all treatment groups as well as in the control group (UNEP 2003)
- Remarks on result:
- other: Effect type: toxicity (migrated information)
- Conclusions:
- In a long term study performed with KCl, no carcinogenic effects were observed in male rats, Groups of 50 male F344/Slc rats were fed KCl in the diet at levels of 110, 450, 1820 mg/kg bw/day for 2 years. A comprehensive examination of the tissue revealed no evidence of treatment related carcinogenicity. Among non-tumerous lesions nephrotic lesion was predominant in all treatment groups as well as in the control group. In tumerous lesions testicular tumour (interstititial cell tumour) developed with a high incidence in all groups. However, the incidence and type of tumour in experimental and control groups were comparable to those of sponateous tumours in the test organism (Imai 1961, UNEP 2003)
- Executive summary:
In a long term study performed with KCl, no carcinogenic effects were observed in male rats, Groups of 50 male F344/Slc rats were fed KCl in the diet at levels of 110, 450, 1820 mg/kg bw/day for 2 years. A comprehensive examination of the tissue revealed no evidence of treatment related carcinogenicity. Among non-tumerous lesions nephrotic lesion was predominant in all treatment groups as well as in the control group. In tumerous lesions testicular tumour (interstititial cell tumour) developed with a high incidence in all groups. However, the incidence and type of tumour in experimental and control groups were comparable to those of sponateous tumours in the test organism (Imai 1961, UNEP 2003)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 45.5 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- There are no dermal Carcinogenic studies available.
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
1820 mg/kg bw/day x 0.025 kg =
NOAELrat = 45.5 mg/kg bw/day
Justification for classification or non-classification
Based on the hazard assessment of Potassium oxide/Dipotassium oxide in 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”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99) and according to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Carcinogenicity Carc. Cat. 1; R45 May cause cancer. Carc. Cat. 1; R49 May cause cancer by inhalation. Carc. Cat. 2; R45 May cause cancer. Carc. Cat. 2; R49 May cause cancer by inhalation. Carc. Cat. 3; R40 Limited evidence of a carcinogenic effect.
|
CLP |
Carcinogenicity Carc. 1A Carc. 1B Carc. 2 H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>. |
It is concluded that the substance Potassium oxide/Dipotassium oxide does not meet the criteria to be classified for human health hazards for Carcinogenicity.
Additional information
Oral effects:
Potassium chloride (KCl) is the most common source of Potassium oxide (K2O).Therefore, the health effects ofpotassiumchlorideneed to be considered in the assessment of Potassium oxide
In a long term study (Imai 1961, UNEP 2003) performed with KCl, no carcinogenic effects were observed in male rats, Groups of 50 male F344/Slc rats were fed KCl in the diet at levels of 110, 450, 1820 mg/kg bw/day for 2 years. A comprehensive examination of the tissue revealed no evidence of treatment related carcinogenicity. Among non-tumerous lesions nephrotic lesion was predominant in all treatment groups as well as in the control group. In tumerous lesions testicular tumour (interstititial cell tumour) developed with a high incidence in all groups. However, the incidence and type of tumour in experimental and control groups were comparable to those of sponateous tumours in the test organism.
There is no reason to believe thatPotassium chlorideas a read across for Potassium oxide has carcinogenic potential.
There are conclusive but not suffcient data for the classification of substance Potassium oxide with regard to carcinogenicity.
NOAEL: 1820 mg/kg bw/day
The NOAEL is the highest tested dose.
Inhalation effects:
There are no Inhalation Carcinogenic studies available.
The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.
NOAEL rat 1820 mg/kg bw/day
÷1.15m3/kgbw
÷20m3/mice
NOAECrat 79.13 mg/m3
Dermal Effects:
There are no dermal Carcinogenic studies available.
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
1820 mg/kg bw/day x 0.025 kg =
NOAELrat = 45.5 mg/kg bw/day
Carcinogenicity: via oral route (target organ): other: all gross lesions and masses
Carcinogenicity: via inhalation route (target organ): respiratory: lung; other: all gross lesions and masses
Carcinogenicity: via dermal route (target organ): other: skin
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