ESTP comments on the draft updated OECD test guideline 407.
The revision of the OECD TG 407 test guideline (repeated dose 28-day oral toxicity study in rodents) focuses on endpoints to detect endocrine activities of chemicals. The new endpoints are likely to influence other previously established core endpoints of this study type. An expert group of pathologists and toxicologists within the European Society of Toxicologic Pathologists (ESTP) has contributed to the scientific discussion of the draft guideline. The advantages and disadvantages of methodical changes as necropsy of all females in dioestrus, blood collection for clinical chemistry and haematology at the same cycle stage, weighing of the thyroid gland and separate weighing of ventral and dorsolateral lobes of the prostate are considered. Possible alternatives are pointed out covering scientific as well as practical aspects.
Bayer HealthCare AG, GDD-Toxicology, Pathology and Clinical Pathology, Aprather Weg, D-42096 Wuppertal, Germany. elke.hartmann@bayerhealthcare.com
Elke
E
Hartmann
Volker
V
Strauss
Rolf
R
Eiben
Alexius
A
Freyberger
Wolfgang
W
Kaufmann
Ingo
I
Loof
Elke
E
Reissmueller
Matthias
M
Rinke
Christine
C
Ruehl-Fehlert
Frederic
F
Schorsch
Ludwig
L
Schladt
D000818:Animals; D004703:Endocrine System / Q000187:drug effects*; D005260:Female; D017408:Guidelines as Topic; D008297:Male; D051381:Rats; D012107:Research Design; D018675:Toxicity Tests / Q000379:methods*