mitations Impacting Environmental Assessments
mitations Impacting Environmental Assessments
mitations Impacting Environmental Assessments
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Li<strong>mitations</strong> <strong>Impacting</strong><br />
<strong>Environmental</strong> <strong>Assessments</strong><br />
Daniel Salvito<br />
Director, <strong>Environmental</strong> Sciences<br />
1 March 2007 CTFA Annual Meeting
<strong>Environmental</strong> Hazard and Risk<br />
Prioritization and assessment of fragrance<br />
materials in the RIFM program has been risk<br />
based<br />
REACH requires hazard and risk assessment<br />
of registered chemicals<br />
Data gaps will need to be addressed<br />
1 March 2007 CTFA Annual Meeting
RIFM Framework for Risk<br />
Assessment<br />
Screening Level Risk Assessment<br />
PEC/PNEC basis:<br />
‣ Aquatic exposure (PEC) calculated from<br />
IFRA volume of use survey data or measured<br />
values, if available<br />
‣ Aquatic effects (PNEC) from QSARs or<br />
measured endpoints<br />
<br />
• Assessment factors applied based on data<br />
quality<br />
Materials are risk-ranked ranked for further testing,<br />
as necessary<br />
1 March 2007 CTFA Annual Meeting
Addressing Data Gaps -<br />
Li<strong>mitations</strong><br />
Animal Testing Issues<br />
QSAR<br />
Ability to Group Chemicals<br />
Risk Assessment , PBTs , and Materials of<br />
Equivalent Concern<br />
1 March 2007 CTFA Annual Meeting
Animal Testing Issues<br />
Cosmetics Directive – 7 th Amendment<br />
‣ In vivo testing and marketing ban for<br />
cosmetic ingredients – 11/3/09<br />
<br />
• Some tests excluded until 11/3/13<br />
‣ Some controversy over whether or not this<br />
applies to environmental studies<br />
Loss of fish testing can affect hazard and risk<br />
assessment<br />
‣ Example: OECD 305 BCF Determination<br />
1 March 2007 CTFA Annual Meeting
QSAR Application<br />
Absent measured values QSARs and other<br />
models may be used to fill data gaps<br />
Concerns arise regarding the “fit” of the<br />
chemical under study to the model domain<br />
‣ Is the structure type adequately covered by<br />
the model?<br />
‣ Are there li<strong>mitations</strong> on physical-chemical<br />
chemical<br />
parameters?<br />
‣ What is the model’s s reliability?<br />
1 March 2007 CTFA Annual Meeting
Problems with K ow based QSARS<br />
Data sets used to build many commonly used<br />
QSARs are<br />
‣ Small<br />
‣ Not structurally diverse<br />
‣ Are limited to log K ow
6<br />
5<br />
Könemann<br />
Regression<br />
Log Estimated LC 50<br />
(mg/L)<br />
4<br />
3<br />
2<br />
1<br />
0<br />
-1<br />
-2<br />
-3<br />
-4<br />
Measured vs. Könemann<br />
n = 24<br />
b = 0.47<br />
m = 0.88<br />
r ² = 0.84<br />
Measured vs. ECOSAR<br />
n = 24<br />
b = -0.14<br />
m = 0.92<br />
r ² = 0.93<br />
ECOSAR<br />
Regression<br />
-5<br />
-5 -4 -3 -2 -1 0 1 2 3 4 5 6<br />
Log Measured LC 50<br />
(mg/L)<br />
Measured Value vs Könemann<br />
Measured Value vs ECOSAR<br />
1 March 2007 CTFA Annual Meeting
5<br />
4<br />
Könemann<br />
Regression<br />
3<br />
Log Estimated LC 50<br />
(mg/L)<br />
2<br />
1<br />
0<br />
-1<br />
-2<br />
-3<br />
-4<br />
Measured vs. Könemann<br />
n = 20<br />
b = 0.69<br />
m = 0.69<br />
r ² = 0.065<br />
Measured vs. ECOSAR<br />
n = 20<br />
b = 0.21<br />
m = 0.63<br />
r ² = 0.063<br />
ECOSAR<br />
Regression<br />
-5<br />
-5 -4 -3 -2 -1 0 1 2 3 4 5<br />
Log Measured LC 50<br />
(mg/L)<br />
Measured vs Könemann QSAR<br />
Measured vs ECOSAR<br />
1 March 2007 CTFA Annual Meeting
Chemical Categorization<br />
REACH Implementation Project 3.3 Task 2<br />
addresses “grouping” of chemicals<br />
Fragrance material industry has provided<br />
input<br />
<strong>Environmental</strong> endpoints of categorization<br />
to be the subject of an upcoming RIFM<br />
Workshop<br />
1 March 2007 CTFA Annual Meeting
Categorization RIP<br />
Draft report has been sent to PMG<br />
‣ Includes Fragrance Appendix<br />
ECB meeting to discuss possible<br />
collaborative projects to test various<br />
methodologies for endpoint categorization<br />
(environmental and human health)<br />
Discussions/planning underway<br />
Outcome possibly integrated with OECD<br />
efforts to revise categorization guidance<br />
1 March 2007 CTFA Annual Meeting
Risk Assessment of PBTs<br />
RIP Endpoint Working Groups on PBTs<br />
identified that risk assessment for these<br />
materials is inappropriate<br />
How might this affect Substances of<br />
Equivalent Concern (SECs(<br />
SECs)?<br />
1 March 2007 CTFA Annual Meeting
Distribution Pathways<br />
Atmosphere<br />
Down<br />
the Drain<br />
Disposal<br />
1 March 2007 CTFA Annual Meeting<br />
SURFACE<br />
WATERS<br />
RIFM Framework and Biotransformation<br />
TREATMENT<br />
PLANT<br />
SOIL<br />
GROUND<br />
WATER<br />
U Delaware<br />
FOOD<br />
CHAIN<br />
Stockholm Univ<br />
SEDIMENTS<br />
Roskilde Univ
Technical Work Groups<br />
ILSI/HESI BCF Working Group/SETAC<br />
Workshop (with Christen Sachse-Vasquez)<br />
‣ Changing how “B” is assessed in regulatory settings<br />
and animal testing issues<br />
ECETOC PBT Task Force<br />
‣ Methodology developed to assess PBTs<br />
and“materials<br />
of equivalent concern”. . Methods<br />
useful in chemical categorization.<br />
USEPA SAB Subcommittee on the use of EPIWIN<br />
‣ Internationally used model to screen chemicals for<br />
hazard characteristics<br />
European Chemicals Bureau RIP 3.3-2 2 Work Group<br />
‣ Working towards including methods for assessing<br />
UVCBs as part of chemical groups<br />
1 March 2007 CTFA Annual Meeting
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