Registration Dossier

Diss Factsheets

Administrative data

additional toxicological information
Type of information:
experimental study
Adequacy of study:
other information
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Method not validated.

Data source

Reference Type:
Initiation of hepatocarcinogenesis by endogenously formed N-nitrosobis(2-hydroxypropyl)amine, N-nitrosodiethanolamine and N-nitroso-2,6-dimethylmorpholine in rats
Yamamoto K et al.
Bibliographic source:
Carcinogenesis 16 (11): 2633-2636.

Materials and methods

Type of study / information:
liver foci test
Principles of method if other than guideline:
see details in remarks on material and methods
GLP compliance:

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): 2,6-dimethylmorpholine

Results and discussion

Any other information on results incl. tables

 Treatment  No. of rats  No of foci (per cm2)

No of foci

(per cm3)

percent of area occupied by foci (%)     
 0.25% DMM  8  1±1  11±9  0.2±0.2    
 0.25% DMM + 0.3% NaNO2  10  32±8  389±106  14.7±9.2    

Number of foci per cm2 were significantly increased in the group given 2,6-dimethylmorpholine together with nitrite compared to values for groups given test article or nitrite alone. Further, the numbers of lesions were essentially similar to those found in rats given carcinogenic doses of Nitroso-dimethylmorpholine. The results clearly demonstrate hepatocyte initiation activities of endogenously formed carcinogens.

Applicant's summary and conclusion