Environmental Safety of Active Pharmaceutical Ingredients

Dr. Richard Reiss Sciences International, Inc. October 20, 2005

1

Introduction
• Talk will focus on triclosan (TCS) and triclocarban (TCC) • For each chemical, I will provide:
– – – – General environmental fate characteristics Representative environmental concentration data Toxicity levels of most sensitive species Comparison of concentrations and toxicity levels

2

General Environmental Fate Properties
• Both compounds have similar fate properties:
– – – Very low vapor pressures Soluble in water Highly adsorbent to organic matter

Both compounds will reach the environment through down-the-drain disposal
– Both show significant degradation in water treatment plants (next slide)

• •

TCS shows rapid removal from water column in dieaway studies (2-5 hour half-life)
– Also, biodegrades in soil in 17-35 days

TCC shows rapid degradation in biosolids (10 hour half-life)
3

Average Removal Rates in Wastewater Treatment Plants
Actives Activated Sludge 94% Trickling Filter

TCC

77%

TCS

95%

83%

Predominant pathway is biodegradation

4

Freshwater Aquatic Environmental Concentrations in U.S. for TCC
Source
TCC Consortium, 2002

Results •Max=0.23 ppb, 90% less than 0.05 ppb

Halden & Paull, •Max=6.8 2005

ppb in sites with significant raw

sewage

EPA E-FAST model, TCC consortium, 2002

•Model estimates, high-end at outfall = 0.017 ppb, median at outfall = 0.0013 ppb
5

Freshwater Aquatic Environmental Concentrations in U.S. for TCS
Source
USGS, 2002

Study •75th Percentile = 0.2 ppb, median of measured conc =0.14 ppb. Sampling locations chosen as “susceptible to contamination.” • Non-detectable in typical flow conditions, Max=0.14 ppb in low flow conditions

USGS, 2004

6

Most Sensitive Aquatic Species
Actives TCC Chronic Toxicity and No Observed Effect Concentrations (NOECs) Waterflea, Ceriodaphnia dubia, NOEC = 1.5 ppb Algae, 6 ppb, minimum algistatic concentration Blue-green algae, NOEC = 0.5 ppb (algistatic, not algicidal, recovery in 3-6 days) Waterflea, Ceriodaphnia dubia, NOEC=6 ppb

TCS

7

Comparison of Environmental Concentrations to NOECs for TCC

1.6
TCC Consortium Measurements

1
8

1.4

Comparison of Environmental Concentrations to NOECs for TCS

7
USGS Measurements
9

Terrestrial Risk
• Both TCS and TCC can be present in sewage sludge in small concentrations
– Sludge may be used as soil amendments in agriculture – Low potential of exposure to ecological species

• Due to low mammalian toxicity, low sludge concentrations, and low potential for exposure, risks to ecological species are expected to be minimal (Federle et al., 2002)
10

Conclusions
• The large majority of the TCC and TCS mass will degrade in treatment plants, but some will be present in effluent and sludge
– Neither is expected to persist in the environment

• TCC shows low risk to aquatic species when high-end concentrations are compared to the no effect level for the most sensitive species

11

Conclusions (cont)
• TCS may have transitory algistatic effects on some algal species under worst case conditions and only in aquatic environments close to the effluent pipe
– Downstream effects are not expected

• TCS is unlikely to have any significant effects on non-algal species

12

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