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EC number: 201-084-3 | CAS number: 78-11-5
- 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
Carcinogenicity
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
- 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.
Referenceopen allclose all
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
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.