Registration Dossier
Registration Dossier
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EC number: 201-084-3 | CAS number: 78-11-5
Toxicological information
Endpoint summary
Administrative data
Description of key information
Reliable information on repeated dose toxicity shows a NOAEL of 2500 mg/kg bw/day. Due to explosive properties of the substance, no further testing could be conducted.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 weeks
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- 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:3100 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:6200 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:12500 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:25000 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:50000 ppmBasis:nominal in diet
- No. of animals per sex per dose:
- 10 males and 10 females
- 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
- Dose descriptor:
- NOAEL
- Effect level:
- <= 50 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- > 12 500 - <= 25 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- Critical effects observed:
- not specified
- Conclusions:
- Effects on the animals cannot be attributed to the ingestion of PETN.
- Endpoint:
- chronic toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 years
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- 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:
- 2 years
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:0 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:6200 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:12500 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:25000 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:50000 ppmBasis:nominal in diet
- No. of animals per sex per dose:
- 50
- Control animals:
- yes
- Details on study design:
- 50 male rats were fed with diets containing 0, 25,000, or 50,000 ppm PETNfor 103 weeks. 50 female rats were fed with diets containing 0, 6,200, or 12,500 ppm PETN for 103 weeks.
- Observations and examinations performed and frequency:
- Cage side observations: No data. Dermal irritation: No dermal study. Body weight: Yes, Male rats receiving diets containing 10 000 ppm weighted 2-5% less than controls male rats. Food consumption and compound intake: Male rats consumed 240-490 mg/ kg day. Food efficiency: No data. Water consumption and compound intake (if drinking water study): No data. Ophthalmoscopic examination: No data. Haematology: No effects. Clinical chemistry: No effects. Neurobehavioural 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):
- Yes, 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
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 200 - < 2 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- > 400 - < 830 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- Critical effects observed:
- not specified
- Conclusions:
- Effects on the animals cannot be attributed to the ingestion of PETN.
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 weeks
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
- Species:
- other: mice
- 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:3100 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:6200 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:12500 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:25000 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:50000 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: 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
- Dose descriptor:
- NOAEL
- Effect level:
- <= 25 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Critical effects observed:
- not specified
- Conclusions:
- Effects on the animals cannot be attributed to the ingestion of PETN.
- Endpoint:
- sub-chronic toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 years
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
- Species:
- other: mice
- 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:0 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:25000 ppmBasis:nominal in diet
- Remarks:
- Doses / Concentrations:50000 ppmBasis:nominal in diet
- No. of animals per sex per dose:
- 50
- Control animals:
- yes
- Details on study design:
- The average amount of PETN consumed per day was approximately 4,000 or 8,100 mglkg for low dose or high dose male mice and 5,100 or 9,700 mg/kg for low dose or high dose female mice.
- 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
- Dose descriptor:
- NOAEL
- Effect level:
- > 4 000 - < 8 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Effects on the animals cannot be attributed to the ingestion of PETN
- Dose descriptor:
- NOAEL
- Effect level:
- > 5 100 - < 9 700 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- Critical effects observed:
- not specified
- Conclusions:
- Effects on the animals cannot be attributed to the ingestion of PETN.
Referenceopen allclose all
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 2 500 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
PETN was found to be nontoxic to both rats and mice in a 13/14-week studies. No effects such as increase in methemoglobin were observed. As no evidence of toxicity of pentaerythritol tetranitrate in the 2- or 13-week studies was found, a 2 -year study on rats and mice was carried out using the maximum dietary concentrations recommended for chronic studies. Survival of treated male rats and male mice was higher than that of controls. No effects directly attributable to the ingestion of pentaerythritol tetranitrate were found.
Repeated dose toxicity: via oral route - systemic effects
(target organ) cardiovascular / hematological: heart; cardiovascular
/ hematological: thymus; digestive: liver; neurologic: brain (multiple
sections); respiratory: lung; urogenital: kidneys
Justification for classification or non-classification
No classification is proposed based on results obtained from the studies.
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.
