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Toxicological information

Carcinogenicity

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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:
1986
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
Name:
Unnamed
Type:
Constituent
Details on test material:
acetylsalicylic acid

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