Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-084-3 | CAS number: 78-11-5
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 weeks
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- No evidence of toxicity or carcinogenicity of pentaerythritol tetranitrate given in the diet to F344 rats and B6C3F1 mice for up to two years.
- Author:
- John R. Bucher, James Huff, Joseph K. Haseman and Scot L. Eustis
- Year:
- 1 990
- Bibliographic source:
- Journal of applied toxicology, Volume: 10 (1)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Pentaerithrityl tetranitrate
- EC Number:
- 201-084-3
- EC Name:
- Pentaerithrityl tetranitrate
- Cas Number:
- 78-11-5
- Molecular formula:
- C5H8N4O12
- IUPAC Name:
- 3-(nitrooxy)-2,2-bis[(nitrooxy)methyl]propyl nitrate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- 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
Doses / concentrationsopen allclose all
- 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
Examinations
- 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
Results and discussion
Results of examinations
- 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
Effect levels
open allclose all
- 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
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Effects on the animals cannot be attributed to the ingestion of PETN.
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.
