Details

Autor(en) / Beteiligte

• Foster, Melanie L.
• Mahapatra, Debabrata
• Maronpot, Robert R.
• Nishino, Masayuki
• Chiba, Shuichi
• Koyanagi, Mihoko
• Burleson, Florence
• Hayashi, Shim-mo

Titel

Extended one-generation reproductive toxicity study evaluating gardenia blue in Sprague Dawley rats

Ist Teil von

• Regulatory toxicology and pharmacology, 2023-10, Vol.144, p.105472-105472, Article 105472

Ort / Verlag

Elsevier Inc

Erscheinungsjahr

2023

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Gardenia blue powder was administered at 0.5%, 2.5%, or 5.0% in feed to male and female Sprague Dawley rats in an Extended One-Generation Reproductive Toxicity Study (OECD Test Guideline 443). The dosed diet began 14 days before mating and was continued at the same concentration level for the entire study for all parental animals (P0) and offspring (F1). At weaning, offspring were allocated into one of 5 cohorts for different endpoints. P0 and F1 animals had blue urine, blue or black feces, and blue discolorations in gastrointestinal organs, mesenteric lymph nodes, and kidneys. This treatment-related finding was not considered adverse as there were no histopathologic correlates. There was a dose-related increase in sperm concentration in P0 and F1 males. There were dose-related increases in heart weights of F1 postnatal day (PND) 21 males, male and female thyroid weights, and female TSH levels of PND 91 F1 offspring, with no histopathological correlate. There were no consistent treatment-related adverse effects on any other parameters evaluated for general toxicity, reproductive toxicity, developmental neurotoxicity, or developmental immunotoxicity. The highest dietary concentration (5.0%) of gardenia blue powder was the no observed adverse effect level (NOAEL) for male and female rats at all life stages evaluated. •Gardenia blue, a natural food colorant, may be consumed at all life stages.•Few natural colorants have been evaluated for safety by international guidelines.•Gardenia blue in diet produced no adverse effects in parental rats.•Prenatal and postnatal exposure produced no adverse effects in offspring.•5.0% gardenia blue in diet is the NOAEL for parental and offspring rats.