Module 3 - Strategic case studies in practice
0.127, rat (liv), Lijinsky et al 1988
3.57, hamster (harmonic mean)
Ames test positive (CPDB)
N- Nitrosomorpholine
NMOR
2B
0.109
Positive in the hisG428 Salmonella strain TA104
0.142
N- nitrosomethylanilin e
0.034 rat, Schmahl et al 1976
NMA, NMPA
(2 dose groups)
0.186
N- Nitrosodi-n- propylamine
Ames test positive (CPDB)
NDPA
2B
0.012 rhesus (liv)
(1 dose group)
0.691
Ames test positive (CPDB)
Nitrosodibutylamine NDBA
2B
1.09 mouse (liv)
(1 dose group)
1.7 rat (liv), Gray et al; 2.43 rat (liv), Berger et al 1987 0.697 mouse (harmonic mean)
Ames test positive (CPDB)
N- nitrosopyrrolidine NPYR
2B
0.799
N- Methyl- N ยด-nitro- N- nitrosoguanidine
0.284 rat (pyl), Zaidi et al 1993
2.03 mouse (harmonic mean)
Ames test positive (CPDB) AMES test negative (CPDB) Ames test positive, Inami et al 2013 Ames test positive (CPDB)
MNNG
2A
0.803
0.982
4-methyl)(nitroso) amino)butanoic acid
NMBA
(1 dose group)
1.31 rat (eso), Gray et al 1991
1.3 mouse (harmonic mean)
N- Nitrosopiperidine NPIP
2B
1.43
N- Nitrosodiethanolami ne N , N- diisopropylethyl- N- ethylamine
0.19 rat (liv) Lijinski et al 1985
Ames positive (CPDB)
NDELA
2B
3.17
Ames test negative, Kameswar et al 1979
positive male only no TD 50 calculated
DIPNA
none
167
N- nitrosodiphenylami ne
Ames test negative (CPDB)
NDPhA
3
mouse, no positive
(2 dose groups)
Abbreviations: CPDB, carcinogenic potency database; eso, oesophagus; liv, liver; lun, lung; pyl, pylorus; ugi, upper gastrointestinal tract.
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