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Volumn 60, Issue 2, 2009, Pages 65-69

Nothing is perfect, not even the local lymph node assay: A commentary and the implications for REACH

Author keywords

False negative; False positive; LLNA; REACH; Regulatory classification; Skin sensitization

Indexed keywords

CHEMICAL COMPOUND;

EID: 58949101632     PISSN: 01051873     EISSN: 16000536     Source Type: Journal    
DOI: 10.1111/j.1600-0536.2008.01444.x     Document Type: Article
Times cited : (44)

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