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Carcinogenicity

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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
Reference
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)

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
Reference
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)

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
Reference
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)

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