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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 231-818-8 | CAS number: 7757-79-1
Carcinogenicity
Administrative data
Description of key information
Potassium nitrate is not genotoxic and no substance related neoplastic lesions were observed in the chronic toxicity study. There is no positive correlation between nitrate intakes and the incidence of cancer.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- other: Evaluation by competent authority
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This publication represents a peer-reviewed evaluation of all published data on carcinogenic potential of nitrates.
- Conclusions:
- There is inadequate evidence in humans for the carcinogenicity of nitrate in food.
There is inadequate evidence in humans for the carcinogenicity of nitrate in drinking water.
There is inadequate evidence in experimental animals for the carcinogenicity of nitrate.
However, ingested nitrate or nitrite under conditions that result in endogenous nitrosation is probably carcinogenic to humans (Group 2A).
There is an active endogenous nitrogen cycle in humans that involves nitrate and nitrite, which are interconvertible in vivo. Nitrosating agents that arise from nitrite under acidic gastric conditions react readily with nitrosatable compounds, especially secondary amines and amides, to generate N-nitroso compounds. These nitrosating conditions are enhanced following ingestion of additional nitrate, nitrite or nitrosatable compounds.
Some of the N-nitroso compounds that could be formed in humans under these conditions are known carcinogens.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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
The weight of evidence approach takes both available data (negative results) and the justification for the absence of data into account. Based on these data, potassium nitrate is not classified for carcinogenicity according to Annex I of Regulation (EC) No. 1272/2008.
Additional information
Justification for selection of carcinogenicity via oral route endpoint:
No single study was selected as key study, the conclusion was derived based on weight-of-evidence.
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.
