carcinogenicityCarcinogenicity studies

Citoxlab – Your partner for carcinogenicity assessment

When prolonged or lifetime exposure to products may occur in humans, an evaluation of carcinogenicity is required. Comprehensive historical control data and the highest standards of husbandry, combined with board certified pathologists and a team of experienced scientists are key elements of the Citoxlab solution.

When you choose Citoxlab, you benefit from expert advice and support throughout your development program. We accompany you from project design, proposing relevant animal models, administration routes and dose selection (including CAC negotiation), and then provide you with the essential robust in vivo and ex vivo data right through to your final submission with SEND.

Mouse and rat studies

Carcinogenicity studies involve exposing rodents to your product for up to a maximum of two years. We collect extensive in-life, survival and histopathology data, and perform full statistical data analysis to evaluate tumor parameters.

 Citoxlab carcinogenicity studies comply with international guidelines and regulations, such as EU (CPMP), ICH, FDA, EPA, JMHW, JMAFF and OECD. Recommended requirements are similar for all these guidelines, although for agrochemicals and industrial chemicals we can combine one of the carcinogenicity studies with a long-term chronic toxicity study. Citoxlab accompanies you through all the strategic choices in your testing package.

Routine carcinogenicity species include:

  • Sprague-Dawley and/or Wistar Han rats
  • CD-1 mice

Transgenic models

Regulatory authorities now accept that carcinogenic potential can be evaluated from data collected in a 2-year rat study, plus a short-term mouse study using a transgenic model. Citoxlab has been very active in the evaluation of these models as part of the ILSI program.

We can offer you 26-week studies in transgenic mouse models (together with a preliminary 4-week toxicity study if necessary). This is often selected as a replacement for the conventional 78- or 104‑week mouse study, which is now judged too long and of limited added value when compared to the rat bioassay.

Currently recommended transgenic models:

  • Tg.rasH2 mouse for genotoxic/non-genotoxic compounds
  • p53 +/- mouse for known genotoxic compounds
  • Tg.AC mouse for dermal drugs