UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

O FFICE PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

MEMORANDUM October 20, 2009

SUBJECT : Summary of Ecotoxicity Data fo r wood oils (040505: Cedarwood Oil; 129035: Cinnamon) for the Registration Review Decision Document.

EPA Reg No.: 040505, 129035, 120011, 129066 Registration Review CAS No.: 8000-27-9, 8021-28-1, 35237-64-0,

FROM : Miachel Rexrode, Ph.D., Senior Biologist /s/ 10/20/2009 Biochemical Pesticides Branch Biopesticide & Pollution Pr evention Division (7511P)

TO: Sadaf Shaukat, Regulatory Action Leader /s / 10/20/2009 Biochemical Pesticides Branch Biopesticide & Pollution Pr evention Division (7511P)

ACTION REQUESTED

The following is the final ecotoxicity assessment for wood oils (040505: Cedarwood Oil; 129035: Cinnamon) in support of the Registra tion Review Decision Document.

RECOMMENDATIONS AND CONCLUSIONS

Executive Summary

Based on the available information for Cinna mon Oils and Cedarwood Oil, the Agency does not foresee the need for additional ecotoxicity data for a new risk assessment and has waived all hazard and exposure data on thes e chemicals. The unique characteristics of these products, their non-toxic mode of action, biodegradability (low to no persistence), and use patterns (non agricultural use, indoor uses) should minimize the risks to all nontargets, including threaten ed and endangered species. Cinnamon oil is a minimum riskpesticide that is exempt from federal regi stration under section 25( b) of the Federal Insecticide, Fungicide, a nd Rodenticide Act (FIFRA) 1 . Cedarwood oil risk in the environment should be low, as noted from calculated RQ values that were about two orders of magnitude below the Agency’s LOCs suggesting minimal risk to terrestrial and aquatic organisms and a no effect (NE) to endangered/threatened species for registered

uses.

Background

Cinnamon oil is a minimum risk pesticide that is exempt from federal registration under section 25(b) of the Federa l Insecticide, Fungicide, and Rodenticide Act (FIFRA) 1

.

Cedarwood oil is among those pesticides for whic h EPA believes a broadly reduced set of generic data requirements is appropriate for reregistra tion. The Agency therefore has waived most generic data requirements for cedarwood oil with the exception of studies that are considered essential, including additional information about chemical purity and product chemistry studies. In evaluating cedarwood oil's potential risks to the environment, EPA relied on information common ly available in scientific literature. Cedarwood oil is a mixture of organic compounds . It is considered Generally Recognized as Safe (GRAS) as a food additive by the Food and Drug Administration. As a pesticide, it repels insects by a non-toxic mode of action. EPA is not aware of any adverse effects caused by cedarwood oil pesticide products when used in a manner prescribed by their labeling. No incidents involving toxic effect s have been reported to the Agency. A laboratory study using mice and a study of wo rkers in saw mills suggest that cedarwood oil may cause liver and pulmonary toxicity. Ho wever, these effects were associated with long term exposures to relatively high levels of cedarwood oil.

Cedarwood oil is a natural com ponent of wood from the tree, Juniperus virginiana L .. It is an active ingredient in fi ve pesticide products that are used as repellents and feeding depressants to control moths and fleas and re tard the growth of mildew. Three of these products are solid cedarwood blocks used to re pel moths from clothing and retard mildew growth on fabrics. The other two products, which contain extracted cedarwood oil, are a pet tag or collar and a liquid sprayed on anim al bedding. Both are intended to repel fleas from household pets. Cedar also is a major component of many non-pe sticidal consumer products currently marketed in the United States.

Although registration as a pesticide is no longer required by EPA for cedarwood oil, several formulations have been registered as pesticides in the past. These formulations include: ready-to-use liquids containing 0.48% cedarwood oil, wood blocks containing 2- 8% cedarwood oil, and pet collars with 0.5% cedarwood oil (EPA, 1993). Two pesticides, Bug Block sunscreen and insect repellent , containing 0.46% Texas cedarwood oil, and Nexa cedarwood oil moth protection, cont aining 40% Virginia cedarwood oil, are registered with the state of California as pesticid es (California EPA, 2001) 2

.
EPA issued its Reregistration Eligibility De cision (RED) document for Cedarwood Oil in 1993. The RED profiles the use of cedarwood oil as a natural repellant/ feeding depressantand fungicide used in houses and on pets or their bedding to repel fleas, moths, and mildew. Based on information collected as the result of the RED, EPA deregulated cedarwood oil in 1996 and no longer requires ma nufacturers of cedarw ood oil products to register them as pesticides (EPA, 1993) 3 . The Agency does not foresee the need for additional ecotoxicity data for a new risk assessment. Ecological effects data requirements were fulfilled by waivers due to low toxicity and use/exposure patterns.

Ecological Effects and Endang ered Species Risk Assessment

Terrestrial Species

The unique characteristics of this product, wood oils, the non-toxic mode of action, biodegradability and low potential for exposur e will result in no risk to all non-target organisms, including threatened and endange red species. Due to the non-toxic mode of action and/or lack of exposure to non-targets by this product, a Risk Quotient (RQ) is not typically calculated since the point estimates of either toxicity and/or exposure will be at or near zero. However, the Agency has estimated potential acute toxicity end points for avian and mammalian species (LD 50 > 5,000 mg/kg) and calculat ed risk quotients (RQs) using the Terrestrial Residue Exposure Mode l (T-REX) Version 1.4.1. A terrestrial risk assessment includes calculated expected residue s, as well as, numerous calculations of dietary exposure for multiple weight cl ass animals (Appendix A). Although cedarwood oil is not used on agricultural crops, expect ed residues were calculated for avian and mammalian food items along with dissipation rate of a chemical applied to foliar surfaces (single or multiple applications) in order to estimate worst case acute RQs relative to weight class for various sized birds and mammals. These calculations showed upper bound Kenega values and that exposure to ce darwood oil (0.01 lbs ai) has a low potential for toxic impact to birds (RQ = 0.0) and mamma ls (RQ= 0.00) that may be feeding in the area of application as noted in Appendix A. The low toxic risk of cedarwood oil to terrestrial organisms, the short environmen tal half life (0.125 days ) and an understanding of the repellent mode of action of this com pound show that there is a very low potential for toxic risk to birds and mammalian species. In addition to this low risk to non-target terrestrial species, the potential for exposure to endangered/threatened species is also very low because the formulated products are used indoors and/or in enclosed areas outdoors. The Agency acute levels of concern (0.1 – 0.5) were not exceeded for terrestrial organisms or for endangered/threatened speci es. Based on this information on the active ingredients, there will not be toxic risk to endangered/ threatened species from exposure to the end use products. Cedarwood oils present a No Effect (N E) to threatened or endangered terrestrial species, if used in accordance with approved labeling

.
Aquatic Species

It is difficult to assess the risks posed to aquatic species from the use of cedarwood oil since uses are contained or indoors. However, in order to assess any potential risk to aquatic life from cedarwood oil, the Agency has evaluated the use of the registered fly repellent for horses as a worst case scenario. Th e label states that a horse can be sprayed with 32 oz of the end product containing 0.50% cedarwood oil as an active ingredient(equivalent to 0.004 mg/L of ai.). The Agency has assumed that af ter spraying, the horse might visit a farm pond (quarter acre pond) where all of the cedarwood oil washes off the animal after immersion in the pond. Although, cedarwood oil is not water soluble, the Agency has estimated exposure concentrations in the top 1 foot of water at 0.014 mg/L (Appendix B). Since the Agency has waived Tier I aquatic toxicity da ta, an estimate of acute toxicity (100 mg/L) was used to asse ss the potential hazard to fish and aquatic organisms. In order to define potential ris k, the Agency calculated aquatic risk quotients (RQ) as an exposure/hazard ratio and deri ved an RQ = 0.00014 whic h is lower that the acute aquatic LOCs (0.05 – 0.5) by about two orde rs of magnitude. This suggests that risk to aquatic organisms from cedarwood oil exposur e in an aquatic environment is very low and that there is a no effect (NE) to aquatic endangered/threatened species

.

III. References

1) EPA Minimum Risk Pesticides. Criteria for FIFRA 25 (b) exemption.

2) California EPA (2001) California Environmen tal Protection Agency Department of Pesticide Regulation, USEPA/OPP Pesticide Re lated Database Queries: Cedarwood Oils.

3) EPA (1993) Reregistration Eligibility Decision (RED) Cedarwood Oils. Washington, DC, US Environmental Protecti on Agency, EPA 738-S-93-012, 169 pp.Appendix A. Extrapolated Toxicity Values Used to Estimate a Worst Case Scenario for Potential Toxic Exposure of Cedarwood Oil to Avian and Mammalian Species.
Acute and Chronic RQs are based on the Upper Bound Kenaga Residues.

Chemical Name: The maximum single day residue estimation is used for

Use both the acute and reproduction RQs.

Formulation Application Rate 0.024 lbs a.i./acre RQs reported as "0.00" in the RQ tables below should be noted as <0.01 in your assessment. This is due to rounding and significant figure issues in Excel. Half-life 0.125 days Application Interval 0.125 days Maximum # Apps./Year 8

Length of Simulation 1 year

Mallard duck LD50 (mg/kg-bw) 5000.00 Bobwhite quail LC50 (mg/kg-diet) 5000.00

Mallard duck NOAEL(mg/kg-bw) 0.00 Mallard duck NOAEC (mg/kg-diet) 0.00

5000.00
5000.00

0.00 0.00

Kenaga V alues Short Grass 5.76 Tall Grass 2.64 Broadleaf plants/sm Insects 3.24 Fruits/pods/seeds/lg insects 0.36

Avian Results

Avian Body Ingestion (Fdry) Ingestion (Fwet) % body wgt FI Class Weight (g) (g bw/day) (g/day) consumed (kg-diet/day)
Small 20 5 2 3 114 2.28E-02
Mid 100 13 65 65 6.49E-02 Large 1000 58 291 29 2.91E-01

Avian Body A djusted LD50 Weight (g) (mg/kg-bw)

20 2596.13 100 3305.00 1000 4668.44

small mid large 20 g 100 g 1000 g Short Grass 6.56 3.74 1.67 Tall Grass 3.01 1.71 0.77 Broadleaf plants/sm Insects 3.69 2.10 0.94 F ru i ts / po d s / see d s /l g i nsects 0.41 0.23 0.10

20 g 100 g 1000 g
Short Grass 0.00 0.00 0.00 Tall Grass 0.00 0.00 0.00 Broadleaf plants/sm insects 0.00 0.00 0.00 Fruits/pods/seeds/lg insects 0.00 0.00 0.00

Acute Chronic Short Grass 0.00 #DIV/0! Tall Grass 0.00 #DIV/0! Broadleaf plants/sm Insects 0.00 #DIV/0! Fruits/pods/seeds/lg insects 0.00 #DIV/0! Endpoints

LC50 (mg/kg-diet) Avian

RQs Dietary-based RQs (Dietary-based EEC/LC50 or NOAEC Avian Acute RQs Dose-based RQs (Dose-based EEC/adjusted LD50) Avian Classes and Body Weights Dose-based EECs
(mg/kg-bw) Upper Bound Kenaga Residues For RQ Calculation

Dietary-based EECs (ppm) NOAEL (mg/kg-bw) NOAEC (mg/kg-diet) Mammals LD50 (mg/kg-bw) cedarwood oil

repelent
spray

)cedarwood oil repelent Upper bound Kenaga Residues Mammalian Results

Mammalian Body Ingestion (Fdry) Ingestion (Fwet) % body wgt FI Class Weight (g bwt/day) (g/day) consumed (kg-diet/day) 15 3 14 95 1.43E-02 Herbivores/ 35 5 23 66 2.31E-02 insectivores 1000 31 153 15 1.53E-01 15 3 3 21 3.18E-03 Grainvores 35 5 5 15 5.13E-03 1000 31 34 3 3.40E-02

Mammalian Body A djusted A djusted

Class Weight LD50 NOAEL 15 10989.15 0.00 Herbivores/ 35 8891.40 0.00 insectivores 1000 3845.80 0.00 15 10989.15 0.00 Grainvores 35 8891.40 0.00 1000 3845.80 0.00

15 g 35 g 1000 g 15 g 35 g 1000 g Short Grass 5.49 3.80 0.88 Tall Grass 2.52 1.74 0.40 Broadleaf plants/sm Insects 3.09 2.13 0.50 Fruits/pods/seeds/lg insects 0.34 0.24 0.06 0.08 0.05 0.01

Acute Chronic A cute Chronic Acute Chronic Short Grass 0.00 #DIV/0! 0.00 #DIV/0! 0.00 #DIV/0! Tall Grass 0.00 #DIV/0! 0.00 #DIV/0! 0.00 #DIV/0! Broadleaf plants/sm insects 0.00 #DIV/0! 0.00 #DIV/0! 0.00 #DIV/0! Fruits/pods/lg insects 0.00 #DI V/0! 0.00 #DIV/0! 0.00 #DIV/0! Seeds (granivore) 0.00 #DIV/0! 0.00 #DIV/0! 0.00 #DIV/0!

Acute Chronic Short Grass 0.00 #DIV/0! Tall Grass 0.00 #DIV/0! Broadleaf plants/sm insects 0.00 #DIV/0! Fruits/pods/seeds/lg insects 0.00 #DIV/0! Dietary-based RQs (Dietary-based EEC/LC50 or NOAEC) Mammal RQs 15 g mammal 35 g mammal 1000 g mammal Dose-based RQs (Dose-based EEC/LD50 or NOAEL) Granivores Mammalian Classes and Body weight Dose-Based EECs
( m g /k g -bw ) Herbivores/ insectivoresAppendix B. Expected Aquatic Exposure Re sidues Calculations for a Quarter Acre Pond

Given: 1 acre-foot = the amount of water that would co ver 1 acre to a depth of 1 foot. This is equivalent to 43,560 cu ft. or 1,233,482 L of wate r. Therefore, a quarter acre pond has the equivalent volume in the surface 1 foot of water of 308,370 L.

Given: 4 oz of end product is equivalent to 113.5 g. If the cedarwood oil represents 0.50% of the net this is equal to 0.57 g of cedarwood oil ai. Therefore, a 32 oz container would contain about 904 g of total product or 4.52 g (4,520 mg) of cedarwood oil.

Assume the entire 32 oz of fly repellent spra y (0.50% cedarwood oil) is used on a 900 lb horse with a surface area of 32.2 ft

Assume that horse visits th e quarter acre pond; as a wors t case scenario the horse is completely immersed in the water and 100% of the cedarwood oil is released into the
water.

If the cedarwood oil is dissipated rapidly within the top 1 ft of water, this will result in about 0.014 mg/L of cedarwood oil released into the environment (0.014 mg/L = 4,520 mg/308,370 L). Since cedarwood oil is not very water soluble, the residues will be concentrated at or near the surface.

Assume that the LC 50 for fish and the EC 50 for daphnia is > 100 mg/L, respectively (since ecotoxicity data have been waived we assume that an acute toxicity end point is > 100 mg/L as would have been determined from an aquatic limit test).

The calculation of risk quotients (RQs) are as follows: 0.014 mg/L/ 100 mg/L = 0.00014. This RQ value is below the Agency’s aqua tic acute level of concern (LOC = 0.05 – 0.5) by about three orders of magnitude and sugge sts that exposure to cedarwood oil should result in little or no risk to fish and aquatic invertebrates.