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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