Registration Dossier
Registration Dossier
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EC number: 200-064-1 | CAS number: 50-78-2
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLPs, Few animals in each groups.
Data source
Reference
- Reference Type:
- publication
- Title:
- The effects of long-term administration of acetylsalicylic acid and sodium saccharin on the rat kidney.
- Author:
- Johansson SL, Sakata T, Hasegawa et al
- Year:
- 1 986
- Bibliographic source:
- Toxicol. Appl. Pharmacol. 86, 80-92
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- the aim of the study was to evaluate the inhibitory effects of acetylsalicylic acid on N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide (FANFT)-initiated and saccharin-promoted bladder carcinogenesis.
- GLP compliance:
- no
Test material
- Reference substance name:
- O-acetylsalicylic acid
- EC Number:
- 200-064-1
- EC Name:
- O-acetylsalicylic acid
- Cas Number:
- 50-78-2
- Molecular formula:
- C9H8O4
- IUPAC Name:
- 2-acetoxybenzoic acid
- Details on test material:
- acetylsalicylic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 68 weeks
- Frequency of treatment:
- continuous in the diet
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5 and 5.0 % of the diet
Basis:
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no post exposure period
Results and discussion
Results of examinations
- Details on results:
- Result (carcinogenicity): negative
Any other information on results incl. tables
Sodium saccharin or acetylsalicylic acid alone reduced the light microscopic incidence and severity of rat nephropathy, a common finding in aging
rats. It would appear that the hyperplastic and renal papillary
toxic effects of acetylsalicylic acid and sodium saccharin
are
independent responses, and that the administration of the
two chemicals together greatly accentuates these responses.
Applicant's summary and conclusion
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.
