Table 1

 Criteria for toxicity evaluation (see reference 16 for meaning of R/S phrases)

Carcinogenicity MutagenicityReproductive and developmental toxicity Irritating potential
Risk phrasesR45, R49R46R60, R61, R62, R63Skin: R21, R24, R27, R34, R35, R38, R43
Eyes: R36, R41
Respiratory tract: R20, R23, R26, R37, R42
Security phrasesSkin: S24, S28, S37
Eyes: S25, S26, S39
Respiratory tract: S22, S23, S38, S51
Swiss SPCPreclinical dataPreclinical dataPregnancy dataChapter ‘Remarks’
Preclinical data
OtherIARC classification in groups 1, 2A and 2B (group 3: should be discuss individually)FDA pregnancy categories X, D (category C: wear protective measures)
  • IARC, International Agency for Research on Cancer; SPC, summary of product characteristics.