About RepDose

RepDose online comprises a subset of about 200 high quality subacute studies with oral exposure of the RepDose database (DB). For full database access please contact Fraunhofer ITEM (repdose@item.fraunhofer.de).

The full content of RepDose is now distributed commercially through a collaboration with MN-AM (Molecular Networks - Altamira). The RepDose database is a valuable addition to the ChemTunes/ToxGPS platform, a high quality of in vitro and in vivo toxicity database and a unique prediction system for the safety and risk assessment. For further information is available from https://www.mn-am.com/products/chemtunes.
RepDose (repeated dose toxicity) is a relational database on subacute to chronic toxicity and currently contains about 930 chemicals.
The toxicity of these chemicals is documented in about 3100 studies, carried out in rats, mice or dogs with oral or inhalation exposure. The database has been developed by Fraunhofer ITEM (Bitsch et al. 2006) with funding from Cefic LRI and grows continuously.

Publicly available, predominantly peer-reviewed studies are entered in the RepDose database.
Sources for data entry are e.g.:
  • German MAK-Documentations
  • EHC
  • EU RAR
  • Reports from German BG Chemie
  • HPV-chemicals
  • NTP reports...
The quality of the study ranked according to the description given in Table 1.

Table 1: data quality criteria used in RepDose
AAccording to OECD guidelines or similar quality
BSome deficiencies, but relevant for the evaluation
CQuality cannot be assessed, (insufficient information)
DSpecial design for a certain endpoint

Each chemical is characterised by at least one, but up to 15 studies, with the majority of chemicals having 1 to 4 studies. L(N)OEL values (lowest (no) observed effects level) are given for each effect and each study.

The description of observed effects and corresponding targets/organs depends highly on the authors/laboratory of the study, even if OECD guidelines are applied. Therefore, harmonised glossaries describing targets/organs and observed effects were created for RepDose.

The content and structure of the database RepDose provide a sound basis to perform analyses on repeated dose toxicity. RepDose is used by the group of chemical risk assessment at Fraunhofer ITEM to analyse and improve risk assessment strategies.
Recent publications with RepDose data:
Tluczkiewicz I, Batke M, Kroese D, Buist H, Aldenberg T, Pauné E, Grimm H, Kühne R, Schüürmann G, Mangelsdorf I, Escher SE. (The OSIRIS Weight of Evidence approach: ITS for the endpoints repeated-dose toxicity (RepDose ITS).) Regul Toxicol Pharmacol. Volume 67, Issue 2, November 2013, Pages 157–169

Escher SE, Batke M, Hoffmann-Doerr S., Messinger H, Mangelsdorf I (2013) Interspecies extrapolation based on the RepDose database - A probabilistic approach. Toxicol Lett. 2013 Apr 12;218(2):159-65.

Batke M, Escher S, Hoffmann-Doerr S, Melber C, Messinger H, Mangelsdorf I (2011) Evaluation of time extrapolation factors based on the database RepDose. Toxicol. Lett. 28;205(2)

Batke M, Aldenberg T, Escher S, Mangelsdorf I. (2013) Relevance of non-guideline studies for risk assessment: the coverage model based on most frequent targets in repeated dose toxicity studies. Toxicol Lett. 2013 Apr 26;218(3):293-8.

Tluczkiewicz, I.; Buist, H.E.; Martin, M.T.; Mangelsdorf, I.; Escher, S.E. (2011) Improvement of the Cramer classification for oral exposure using the database TTC RepDose - A strategy description. Reg. Toxicol. and Pharmacol. 61, 340-350

Escher SE, Tluczkiewicz I, Batke M, Bitsch A, Melber C, Kroese ED, Buist HE & Mangelsdorf I (2010) Evaluation of inhalation TTC values with the database RepDose. Regul. Toxicol. Pharmacol. 58(2):259-274