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Toxicological information

Carcinogenicity

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Administrative data

Description of key information

A reliable 2 -year studies in which male/female F344/N rats, showed a little increase in neoplasms of the Zymbal gland. There was no evidence of carcinogenic activity of PETN, NF, for male or female B6C3Fi mice fed diets containing 25,000 or 50,000 ppm for 2 years.

No nonneoplastic lesions were attributed to PETN, NF, administration. The ingestion of PETN is not conclusive to determine carcinogenic effects for rats.

Carcinogenicity: via oral route (target organ): glandular: thyroids

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
GLP compliance:
not specified
Species:
rat
Strain:
Fischer 344
Sex:
male/female
Route of administration:
oral: drinking water
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
daily
Remarks:
Doses / Concentrations:620 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:1240 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:2500 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:5000 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:10000 ppmBasis:nominal in diet
No. of animals per sex per dose:
10
Control animals:
yes
Observations and examinations performed and frequency:
Cage side observations: No dataDermal irritation: No dermal study Body weight: Yes, female rats receiving diets containing 5000 or 10 000 ppm weighted 6-7% less than controlsFood consumption and compound intake: No dataFood efficiency: No dataWater consumption and compound intake (if drinking water study): No dataOphthalmoscopic examination: No dataHaematology: No effectsClinical chemistry: No effectsNeurobehavioural examination: No effects
Sacrifice and pathology:
Gross pathology: No effectsHistopathology: An adenoma of the Zymbal gland was observed in 1/10 high-dose female rats
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Female rats receiving diets containing 5000 or 10 000 ppm weighted 6-7% less than controls
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
effects observed, treatment-related
Description (incidence and severity):
low increase of adenoma of the Zymbal gland
Relevance of carcinogenic effects / potential:
The ingestion of PETN is not conclusive to determine the carcinogenic effects observed in the animals.
Conclusions:
Effects on the animals cannot be attributed to the ingestion of PETN.
Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
GLP compliance:
not specified
Species:
rat
Strain:
Fischer 344
Sex:
male
Route of administration:
oral: drinking water
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 years
Frequency of treatment:
daily
Remarks:
Doses / Concentrations:0Basis:nominal in diet
Remarks:
Doses / Concentrations:5000 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:10000 ppmBasis:nominal in diet
No. of animals per sex per dose:
50
Control animals:
yes
Observations and examinations performed and frequency:
Cage side observations: No dataDermal irritation: No dermal study Body weight: Yes, Male rats receiving diets containing 10 000 ppm weighted 2-5% less than controls male ratsFood consumption and compound intake: Male rats consumed 240-490 mg/ kg day.Food efficiency: No dataWater consumption and compound intake (if drinking water study): No dataOphthalmoscopic examination: No dataHaematology: No effectsClinical chemistry: No effectsNeurobehavioural examination: No effects
Sacrifice and pathology:
Mortality: survival, control 22/50, low dose 29/50, high dose 29/50Histopathology: carcinomas of the Zymbal gland
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Male rats receiving diets containing 10 000 ppm weighted 2-5% less than controls male rats
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
Male rats consumed 240-490 mg/ kg day.
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
effects observed, treatment-related
Description (incidence and severity):
low increase of adenoma of the Zymbal gland
Relevance of carcinogenic effects / potential:
The ingestion of PETN is not conclusive to determine the carcinogenic effects observed in the animals.
Conclusions:
Effects on the animals cannot be attributed to the ingestion of PETN.
Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
GLP compliance:
not specified
Species:
rat
Strain:
Fischer 344
Sex:
female
Route of administration:
oral: drinking water
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 years
Frequency of treatment:
daily
Remarks:
Doses / Concentrations:0Basis:nominal in diet
Remarks:
Doses / Concentrations:1240 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:2500 ppmBasis:nominal in diet
No. of animals per sex per dose:
50
Control animals:
yes
Observations and examinations performed and frequency:
Cage side observations: No dataDermal irritation: No dermal study Body weight: No effectsFood consumption and compound intake: Male rats consumed 80-165 mg/ kg day.
Sacrifice and pathology:
Mortality: survival, control 33/50, low dose 33/ 50, high dose 31/50Histopathology: carcinomas of the Zymbal gland and thyroid gland
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Male rats receiving diets containing 10 000 ppm weighted 2-5% less than controls male rats
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
Male rats consumed 240-490 mg/ kg day.
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
effects observed, treatment-related
Description (incidence and severity):
carcinomas of the Zymbal gland and thyroid gland
Relevance of carcinogenic effects / potential:
The ingestion of PETN is not conclusive to determine the carcinogenic effects observed in the animals.
Conclusions:
Effects on the animals cannot be attributed to the ingestion of PETN.
Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
GLP compliance:
not specified
Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Route of administration:
oral: drinking water
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
daily
Remarks:
Doses / Concentrations:620Basis:nominal in diet
Remarks:
Doses / Concentrations:1240 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:2500 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:5000 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:10000 ppmBasis:nominal in diet
No. of animals per sex per dose:
50
Control animals:
yes
Observations and examinations performed and frequency:
Cage side observations: No dataDermal irritation: No dermal study Body weight: No effectsFood consumption and compound intake: No dataFood efficiency: No dataWater consumption and compound intake (if drinking water study): No dataOphthalmoscopic examination: No dataHaematology: No effectsClinical chemistry: No effectsNeurobehavioural examination: No effects
Sacrifice and pathology:
Gross pathology: No effectsHistopathology: An adenoma of the Zymbal gland was observed in 1/10 high-dose female mice
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
effects observed, treatment-related
Description (incidence and severity):
low increase of adenoma of the Zymbal gland
Relevance of carcinogenic effects / potential:
The ingestion of PETN is not conclusive to determine the carcinogenic effects observed in the animals.
Conclusions:
Effects on the animals cannot be attributed to the ingestion of PETN.
Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
GLP compliance:
not specified
Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Route of administration:
oral: drinking water
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 years
Frequency of treatment:
daily
Remarks:
Doses / Concentrations:0Basis:nominal in diet
Remarks:
Doses / Concentrations:5000 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:10000 ppmBasis:nominal in diet
No. of animals per sex per dose:
50
Control animals:
yes
Observations and examinations performed and frequency:
Cage side observations: No dataDermal irritation: No dermal study Body weight: No effectsFood consumption and compound intake: Male mice consumed 810-1620 mg/ kg day; female mice consumed 1020-1936 mg/kg dayClinical chemistry: No clinical effects
Sacrifice and pathology:
Moratality: Survival of dosed male mice was greater than that of controls [survival: controls 26/49 (one animal was mis-sexed), low dose 38/50, high dose 38/50]; survival of female mice did not differ among groups (38/50, 30/50, 38/50).Histopathology: No effects
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
, Male mice consumed 810-1620 mg/ kg day; female mice consumed 1020-1936 mg/kg day
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Relevance of carcinogenic effects / potential:
The ingestion of PETN doesnot induce cancer
Conclusions:
Effects on the animals cannot be attributed to the ingestion of PETN.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
490 mg/kg bw/day

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Experimental reliable data indicate that pentaerythritol tetranitrate does not produce tumors.

Additional information