Tab.5. Carcinogenicity study with N,N-dimethyl-p-toluidine in mice.
| Author: | NTP 2012 | ||||
| Substance: | N,N-dimethyl-p-toluidine (purity: > 99%) | ||||
| Species: | mouse, B6C3F1, groups of 50 ♂, 50 ♀ | ||||
| Administration route: | oral, gavage | ||||
| Dose: | 0, 6, 20, 60 mg/kg body weight and day | ||||
| Duration: | 2 years, 5 days/week | ||||
| Toxicity: | 6 mg/kg body weight and day and above: liver: hypertrophy, necrosis, nose: ♀: hyperplasia, metaplasia; 20 mg/kg body weight and day and above: lungs: ♀: alveolar epithelium hyperplasia, forestomach: ♀: hyperplasia (Section 5.2.2) |
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Dose [mg/kg body weight] | |||
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0 | 6 | 20 | 60 |
| surviving animals | ♂ | 34/50 (68%) | 36/50 (72%) | 31/50 (62%) | 36/50 (72%) |
| ♀ | 43/50 (86%) | 40/50 (80%) | 39/50 (78%) | 32/50 (64%) | |
| tumours and pre-neoplastic lesions | |||||
| liver: |
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| hepatocellular adenomas, multiple | ♂ | 17/50 (34%) | 19/50 (38%) | 27/50 (54%)* | 26/50 (52%)* |
| ♀ | 2/50 (4%) | 6/50 (12%) | 29/50 (58%)** | 35/50 (70%)** | |
| hepatocellular adenomas | ♂ | 29/50 (58%) | 34/50 (68%) | 37/50 (74%) | 36/50 (72%) |
| ♀ | 17/50 (34%) | 19/50 (38%) | 37/50 (74%)** | 44/50 (88%)** | |
| hepatocellular carcinomas | ♂ | 22/50 (44%) | 25/50 (50%) | 30/50 (60%) | 36/50 (72%)* |
| ♀ | 6/50 (12%) | 13/50 (26%)* | 18/50 (36%)** | 31/50 (62%)** | |
| hepatoblastomas | ♂ | 1/50 (2%) | 5/50 (10%) | 10/50 (20%)* | 8/50 (16%)* |
| ♀ | 0/50 | 1/50 (2%) | 0/50 | 4/50 (8%)* | |
| lungs: |
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| bronchiolar-alveolar adenomas | ♀ | 2/50 (4%) | 4/50 (8%) | 8/50 (16%)* | 12/50 (24%)* |
| bronchiolar-alveolar adenomas and carcinomas | ♀ | 2/50 (4%) | 5/50 (10%) | 9/50 (18%)* | 13/50 (26%)* |
| forestomach: |
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| squamous cell papillomas | ♂ | 1/50 (2%) | 1/50 (2%) | 0/50 | 3/50 (6%) |
| ♀ | 1/50 (2%) | 5/50 (10%) | 6/50 (12%)* | 7/50 (14%)* | |
| squamous cell papillomas or carcinomas | ♀ | 1/50 (2%) | 6/50 (12%) | 6/50 (12%)* | 7/50 (14%)* |
p ≤ 0.05
p ≤ 0.01