Cholesterol - Adverse Effects
Fluorinated and Fluoride Pesticides

The use of high doses increases the likelihood that potentially significant toxic effects will be identified. Findings of adverse effects in any one species do not necessarily indicate such effects might be generated in humans. From a conservative risk assessment perspective however, adverse findings in animal species are assumed to represent potential effects in humans, unless convincing evidence of species specificity is available.

-- Food and Agricultural Organization of the United Nations

Note: This is not an exhaustive list.
When time allows more information will be added.

Ammonium fluoride - Wood Preservative - CAS No. 12125-01-8

Male Wistar rats were exposed to ammonium fluoride vapours in a toxicological chamber for 3 months.Exposure to NH4F was for 3 months, 6 hours per day and 5 days per week, in a toxicological chamber... a concentration of 2 mg/m 3 was administered in the form of aerosol in air... Biochemical tests in liver homogenate... Total cholesterol: Ammonium fluoride caused a rise of 65% in cholesterol levels. Quercetin at either dose markedly reduced the content of cholesterol in liver. Triglycerides: Triglycerides in liver homogenate were increased by 61% in the NH4F group. When quercetin was administered the level of triglycerides fell to near-normal values. DISCUSSION In this work chronic exposure of rats to ammonium fluoride led to a sharp increase in the concentration of total lipids, triglycerides, and cholesterol in serum. The content of cholesterol in the microsomal fraction rose, while the content of phospholipids fell... Abnormal enzyme activities seem to be one of the chief factors responsible for the rise in serum triglycerides and cholesterol. It appears that enzymes inhibited by fluoride, such as triglyceride lipase, unspecific esterases, and pyro-phosphatase, were involved. Opinions as to the influence of fluorides on cholesterol levels are controversial. Some authors did not observe any changes after fluoride exposure, while others have confirmed the hypercholestero-lemic effect of fluorine compounds... CONCLUSIONS - Chronic exposure to ammonium fluoride vapours leads to changes in lipid metabolism in experimental animals.
Ref: B Czerny et al. (2000). The influence of quercetin on some parameters of lipid metabolism in rats chronically exposed to ammonium fluoride. Fluoride, Vol. 33, No. 1; 27-32.

Chlorfenapyr - Acaricide, Insecticide - CAS No. 122453-73-0

The 100-fold margin of safety is adequate to assure a reasonable certainty of no harm to infants and children from the proposed use. As stated earlier, the NOAEL is based on the effects observed in the rat and mouse chronic oncogenicity studies, (reduced bwt gains, increased globulin and cholesterol values and increased liver weights in the rat and reduced bwt gains and vacuolation of white matter of the mouse brain), the 1-year neurotoxicity study in the rat, (reduced bwt gains and vacuolar myelinopathy of [[Page 46680]] the brain and spinal cord that is completely reversible following termination of treatment and is not associated with any damage to neuronal cell bodies or axons; vacuolation of the white matter is a consequence of edema (water) formation between the myelin layers which result from the unrestricted movement of ions across the cell membranes) and the 2-generation rat reproduction study, (reduced bwt gains for parental animals and reduced pup body weights for the F1 and F2 litters; however no behavioral changes were observed in either F1 or F2 offsprings in the 2-generation reproduction study)...
Ref: Federal Register: August 26, 1999 [Page 46677-46680]. Notice of Filing; Pesticide Petition.

Chlorodifluoromethane - Insecticide, Fungicide, Propellant - CAS No. 75-45-6

Lee and Suzuki (1981) exposed groups of 16 male Sprague-Dawley rats to 0 or 50,000 ppm HCFC-22 for 5 hours/day, 7 days/week for 8 weeks (duration- adjusted concentrations = 0 or 36,800 mg/cu.m, respectively). Six rats/group were sacrificed at 8 weeks, and the rest were used in a fertility study (discussed below). The only exposure-related effects noted were a slight decrease in prostate weight (without accompanying histopathological changes), an increase in plasma cholesterol, and decreases in plasma glucose and triglycerides. The toxicological significance of these changes is not clear because functional studies on adrenal or hepatic function were not undertaken, and there were no histopathological changes in these organs. Nevertheless, a LOEL of 50,000 ppm [LOEL(HEC) = 36,800 mg/cu.m] can be estimated from this study.
Ref: US EPA IRIS (Integrated Risk Information System).

Cloransulam-methyl - Herbicide - CAS No. 147150-35-4

In the rat Chronic Feeding / Carcinogenicity study the NOEL was equal to 75 mg/kg/day and the Lowest Observed Effect Level (LOEL) was 325 mg/kg/day based on significant increase in hemoglobin, hematocrit, and red cell count in males, activities of the liver enzymes aspartate and alanine aminotransferase as well as alkaline phosphatase were decreased in males, cholesterol was decreased in females, specific gravity of urine was decreased in females, increased relative weight in liver and relative weight of testes in males, males exhibited an increased incidence of collecting duct hypertrophy and females exhibited increased incidence of vacuolation in the kidney.
Ref: US EPA Fact Sheet. October 29, 1997.

Cyhalothrin, lambda - Insecticide - CAS No. 91465-08-6

Subchronic toxicity. A 90-day feeding study in which rats were fed doses of 0, 50, 150, and 350 ppm with a NOEL of 50 ppm and a lowest observed effect level (LOEL) of 150 ppm based on mild dose changes in hemoglobin, cholesterol, and liver weight.
Ref: Federal Register: September 25, 1997 [Page 50337-50367]. Notice of Filing of Pesticide Petitions.

Diflufenican - Herbicide - CAS No. 83164-33-4

--Subacute toxicity studies... In a 13-week oral study in the dog, the minimum effect level was 250 mg/kg bw based on enemis and increased cholesterol levels at the 250 mg/kg bw/day dose level. The observed effects at higher dose levels included impaired body weight gain, emesis, increased plasma cholesterol and increase in the relative thymus weights.
Ref: September 1995. Evaluation on Diflufenican. Evaluation of fully approved or provisionally approved products. Department for Environment, Food and Rural Affairs, Pesticides Safety Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York YO1 7PX, UK. Available at:

Ethalfluralin - Herbicide - CAS No. 55283-68-6

A three month oral study with beagle dogs had doses of 0, 6.25, 27.5, or 125/80 mg/kg/day by capsule. The systemic NOEL was 27.5 mg/kg/day. The systemic LOEL was 80 mg/kg/day (the high dose) based on elevated alkaline phosphatase, slight fatty metamorphosis of the liver, increased cholesterol, and increased BUN. (MRID 00135193)
Ref: US EPA. Reregistration Eligibility Decision (RED): Ethalfluralin. March 1995.

Fipronil - Acaricide, Insecticide - CAS No. 120068-37-3

An acceptable chronic rat feeding study identified the following effects: seizures, including seizures resulting in death, decreased body weight gain, decreased food consumption and food conversion efficiency, decreased hematology measures, alterations in clinical chemistry (cholesterol, calcium, and protein), alterations in thyroid hormones, alterations in urine chemistry, changes on gross necropsy, increase in liver and thyroid weights, and progressive senile nephropathy (kidney effects). The NOEL for systemic toxicity was 0.5 ppm. The LOEL of 1.5 ppm was based on an increase in incidence of clinical signs and alterations in clinical chemistry and thyroid parameters. Based on this study, the RfD Committee recommended that the RfD be established using the NOEL and an uncertainty factor of 100 to account for the interspecies extrapolation and intraspecies variability. The RfD was set at 0.0002 mg/kg/day.
Ref: US EPA. New Pesticide Fact Sheet. May 1996.

Fluazifop-butyl - Herbicide - CAS No. 69806-50-4

-- Fluazifop-butyl (CAS # 69806-50-4) was evaluated for subchronic dietary toxicity in Wistar rats (20/sex/group) receiving 0, 10, 100 and 2000 ppm by dietary inclusion for 13 weeks. Mean achieved dosages during 13-week treatment were 0, 0.7, 7.1 and 144.5 mg/kg/day in males of the respective treatment groups and 0, 0.8, 8.0 and 161.9 mg/kg/day in females... cholesterol and total protein concentrations were low as compared to controls. [ICI AMERICAS INC; 13 Week Dietary Toxicity Study with PP009 in Rats (Final Report); 05/29/80; EPA Doc No. 88-920006943; Fiche No. OTS0545346]
-- Fluazifop-butyl (CAS # 69806-50-4) was evaluated for subacute oral toxicity in Wistar albino rats (10/sex/group) administered 10 ml/kg doses in corn oil of 0, 4, 20, 100 and 500 mg/kg/day by oral gavage, 5 days/week for 2 weeks. Five-day weekly treatment periods were each followed by 2-day recovery... Blood chemistry indicated a dose-related elevation of alkaline phosphatase activity in 100 and 500 mg/kg/day males, elevated aspartate amino-transferase activity in 500 mg/kg/day males, and elevated cholesterol concentrations in 500 mg/kg/day males and females. Conversely, enzyme activity was depressed in rats of lower dosages... [ICI AMERS INC; 14 Day Subacute Oral Toxicity Study with PP009 in Rats; 07/11/80; EPA Doc No. 88-920007017; Fiche No. OTS0545392]
Ref: TOXNET profile from Hazardous Substances Data Bank for FLUAZIFOP-BUTYL.

**411-083 069476 Virgo, D. M., "Fluazifop-butyl: 55 week oral toxicity study in beagle dogs," Life Science Research, Stock, Essex, England, 10/15/82. LSR Report No. 81/ILK019/620. Six dogs/sex/group were dosed for 55 weeks with Fluazifop-butyl, 99.6% purity, by gelatin capsules at dose levels of 0, 5, 25, and 125 mg/kg/day in a chronic study. Test article within capsules was dissolved in 0.4 ml/kg corn oil vehicle. NOEL = 5 mg/kg/day... All other noteworthy findings were limited to the high dose group, as follows. Seven 125 mg/kg/day dogs (5 M, 2 F) were killed in extremis prior to term, generally after at least 29 weeks on study ... Cholesterol was consistently reduced. Male reproductive toxicity included testicular tubular degeneration and reduced/absent spermatozoa in epididymides. Possible adverse effects (many-faceted toxicity, including mortalities, at 125 mg/kg/day). Acceptable. Aldous, 5/20/02.
Ref: May 20, 2002. SUMMARY OF TOXICOLOGY DATA FLUAZIFOP-P-BUTYL. California EPA. Department of Pesticide Regulation. Medical Toxicology Branch.

Fluazinam - Fungicide - CAS No. 79622-59-6

-- 21-Day dermal toxicity rats: increased AST and cholesterol levels in clinical chemistry determinations (males).
Special studies: 4-Week dietary (Range-finding) rats- decreased body weight gain and food consumption, increased serum phospholipids, increased total
cholesterol, increased relative liver weights, and liver histopathology.
-- 4-Week dietary (Range-finding) mice- decreased body weight gain, increased serum glucose, increased kidney weights.
-- 4-Week dietary (Range-finding) rats. NOAEL = Males: 5.1 mg/kg/day; Females: 5.3 mg/ kg/day LOAEL = Males: 26.4 mg/kg/day; Females: 25.9 mg/ kg/day based on decreased body weight gain and food consumption, increased serum phospholipids, increased total cholesterol, increased relative liver weights, and liver histopathology.
Ref: Federal Register: April 18, 2002 [Page 19120-19130]. Fluazinam; Pesticide Tolerance. Final Rule.

Fludioxonil - Fungicide - CAS No. 131341-86-1

A chronic oral toxicity study in dogs dosed for 52 weeks at 0, 100, 1,000, and 8,000 ppm in the diet (0, 3.1, 33.1, and 297.8 mg/kg/ day in males; 3.3, 35.5, and 330.7 mg/kg/day in females. The LEL is 297.8 mg/kg/day for male dogs based on decreased body weight, hematology alterations (increase in platelets and fibrin), clinical chemistry alterations (increase in cholesterol and alkaline phosphatase) and increased liver weight. The LEL is 35.5 mg/kg/day for female dogs based on a marked decrease in body weight gain for weeks 1 - 13 and weeks 1 - 52 of the study. The NOEL is 33.1 mg/kg/day for male dogs and 3.3 mg/kg/day in female dogs.
Ref: Federal Register: October 29, 1997 [Page 56075-56082]. 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile; Pesticide Tolerance. Final Rule.

Flufenacet - Herbicide - CAS No. 142459-58-3

A 1-year dog chronic feeding study with a NOEL was 40 ppm (1.29 mg/kg/day in males and 1.14 mg/kg/day in females) and a LOEL of 800 ppm (27.75 mg/kg/day in males and 26.82 mg/kg/day in females) based on increased alkaline phosphatase, kidney, and liver weight in both sexes, increased cholesterol in males, decreased T2, T4 and ALT values in both sexes, and increased incidences of microscopic lesions in the brain, eye, kidney, spinal cord, sciatic nerve and liver.
Ref: Federal Register: September 23, 1998. Flufenacet; Time-Limited Pesticide Tolerance. Final Rule.

Flumioxazin - Herbicide - CAS No. 103361-09-7

-- 870.3150 90-Day capsule - dog NOAEL = mg/kg/day: 10 (M & F) LOAEL = mg/kg/day: 100 (M & F) based on dose dependent increase in total cholesterol, phospholipid & alkaline phosphatase
Ref: US EPA Pesticide Fact Sheet. April 12, 2001.

Flurprimidol - Plant Growth Regulator - CAS No. 56425-91-3

Chronic Studies. Rodent Feeding Studies. A 2-year study in rats treated with either 0, 1.0, 3.6, 12.1 and 41.2 mg/kg/day of flurprimidol technical for males and 0, 1.2, 4.4, 14.5, and 49.3 mg/kg/day for females the NOEL was 3.6 mg/kg/day and the LEL was 12.1 mg/kg/day based upon hepatocellular changes in males including enzyme induction, fatty change, hepatocellular eosinophilic change and focal atypia. At 41.2 mg/kg/day there was also a transient body weight and weight gain decrease (males), increased cholesterol and triglycerides (males and females) increased hepatic enzyme induction and liver weight, fatty change and hepatocellular eosinophilic change (females). No oncogenic potential was observed at any dose level.
Ref: EPA Pesticide Fact Sheet Name: Flurprimidol.

Flutolanil - Fungicide - CAS No. 66332-96-5

Chronic toxicity. A 1-year dog chronic feeding study with a NOEL was 40 ppm [1.29 mg/kg/day in males and 1.14 mg/kg/day in females] and a LOEL of 800 ppm [27.75 mg/kg/day in males and 26.82 mg/kg/day in females] based on increased alkaline phosphatase, kidney, and liver weight in both sexes, increased cholesterol in males, decreased T2, T4 and ALT values in both sexes, and increased incidences of microscopic lesions in the brain, eye, kidney, spinal cord, sciatic nerve and liver.
Ref: Federal Register: June 23, 1998 [Page 34176-34184]. Notice of Filing of Pesticide Petitions.

Haloxyfop-methyl - Herbicide - CAS No. 69806-40-2

-- 13-Week Feeding - dog: Dietary levels tested: 0, 2, 5, and 20 mg/kg/day; Beagle dogs (4/sex/dose level) were administered haloxyfop-methyl in the diet for 13 weeks. A statistically significant decrease in serum cholesterol values was reported for males fed 2 mg/kg/day. A statistically significant decrease in serum cholesterol values was reported for males and females fed 5 mg/kg/day. A significant decrease in male and female triiodothyronine and free thyroxine values was accompanied by a significant decrease in male and female relative thyroid/parathyroid weights. Hepatic peroxisomal fatty acid beta-oxidation was increased in males and females fed 5 mg/kg/day. Histological changes reported at this level were hepatocellular enlargement with increased glycogen content, decrease in follicular size and hypertrophy of the follicular epithelial cells of the thyroid, and decrease size of the testicular tubules. The LEL for systemic toxicity is 2 mg/kg/day, the lowest dose tested, based on decreases in serum cholesterol values in males. A NOEL for systemic toxicity was not established; core grade minimum (Dow Chemical Co., 1987a)
Ref: Health Assessment. US EPA Integrated Risk Information System (IRIS).

Isoxaflutole - Herbicide - CAS No. 141112-29-0

In a combined chronic toxicity/carcinogenicity study, isoxaflutole was continuously administered to 75 Sprague-Dawley rats/ sex/dose at dietary levels of 0, 0.5, 2, 20 or 500 mg/kg/day for 104 weeks. An additional 20 rats/sex/group were treated for 52 weeks, after which 10 rats/sex/group were sacrificed and the remainder were held for a maximum of 8 weeks without treatment in order to assess reversibility of treatment-related changes. Evidence of systemic toxicity observed at 500 mg/kg/day in one or both sexes included: abnormal gait, limited use of limbs, lower body weight gains and food consumption, decreased food efficiency during the first 14 weeks of the study, elevated cholesterol levels throughout the 104-week study, increased absolute and relative liver weights, and thyroid hyperplasia.
Ref: Federal Register: September 23, 1998. Isoxaflutole; Pesticide Tolerance. Final Rule.

Norflurazon - Herbicide - CAS No. 27314-13-2

A 90-day rat feeding study at nominal dosages of 0, 12.5, 25.0 and 125.0 mg/kg/day... at the mid-dose level there were increases of cholesterol in both sexes (23 to 40 percent in males, 6 to 34 percent in females), a decrease in SGPT (36 to 38 percent in males, 13 to 20 percent in females) and SGOT (4 to 23 percent in males, 13 to 23 percent in females). At the highest level, similar changes were observed in male and female dogs, with the additional observation of a decrease in red cell count in female dogs (79 to 92 percent of control). The systemic NOEL was determined to be 1.53 mg/kg/day for males and 1.58 mg/kg/day for females. The systemic LEL was determined to be 5.02 mg/kg/day for males and 4.77 mg/kg/day for females, based on increased absolute and relative liver weight and increased cholesterol in both sexes.
Ref: Federal Register: July 29, 1996 [Page 39347-39351]. Norflurazon; Pesticide Tolerance. Final Rule.

The chronic NOAEL of 1.5 mg/kg/day was established based on increased absolute and relative liver weight and increased cholesterol in both sexes in a 6-month feeding study in dogs at the LOAEL of 4.77 mg/kg/day... The acute and chronic dietary exposure analyses are based on the Dietary Exposure Evaluation Model (DEEM TM .) The acute dietary exposure estimates used the entire distribution of single day food consumption. The chronic dietary exposure estimates the three day average consumption for each population subgroup. The DEEM TM analysis was conducted using consumption data from the USDA 1989-92 Continuing Surveys for Food Intake by Individuals (CSFII).
Ref: US EPA May 31, 2002. Tolerance Reassessment Progress and Risk Management Decision.

Noviflumuron - Insecticide - CAS No. 121451-02-3

-- 007; 186499; XDE-007: 28-Day Dietary Toxicity Study in CD-1 Mice (Yano, B.L. and Day, S.J., Toxicology & Environmental Research and Consulting, The Dow Chemical Company, Midland, MI, Laboratory Project Study ID 001248, 6/12/01). XDE-007 (Lot, Reference No. F0031-148, TSN102332, purity = 98.4%) was admixed to the feed and fed to 5 CD-1 mice per sex per dose at dose levels of 0, 10, 100, 500, or 1000 mg/kg/day (0, 10.8, 110, 538, 1060 mg/kg/day, respectively for males and 0, 11.2, 113, 504, 1140 mg/kg/day, respectively for females) for 28 days. No mortalities occurred. No treatment-related clinical signs were observed. Treatment-related increases in mean platelet level and mean cholesterol level were observed in both sexes at 100, 500, and 1000 mg/kg/day. A treatment-related increase in mean relative liver weight was observed at in males at 100, 500, and 1000 mg/kg/day and in females at 500 and 1000 mg/kg/day. Microscopic examination revealed treatment-related hepatocellular hypertrophy with altered tinctorial properties (centrilobular/midzonal to panlobular) in males at 500 and 1000 mg/kg/day and very slight vacuolation (consistent with fatty change) of the periportal hepatocytes in males at 500 and 1000 mg/kg/day and in females at 1000 mg/kg/day. No adverse effects. NOEL (M) = 10.8 mg/kg/day and NOEL (F) = 11.2 mg/kg/day (based on increases in mean platelet and mean cholesterol levels). Supplemental (because only 5 animals per sex per dose were used and because the animals were treated for only 28 days). (Corlett, 9/30/02)
Ref: September 26, 2002. Summary of Toxicology Data for Novidlumuron ((XDE-007) or N-(((3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl)amino)carbonyl)-2,6- diflurobenzamide. California EPA, Department of Pesticide Regulation, Medical Toxicology Branch.

PFOS - PFOS - Insecticide, US EPA List 3 Inert

Due to length, click here for effects page

Quinoxyfen - Fungicide - CAS No. 124495-18-7

** 040 - 181140 XDE-795: "Two-Year Dietary Chronic Toxicity/Oncogenicity Study in Fischer 344 Rats-Final Report," (Redmond, J.M., Quast, J.F., Bond, D.M., Ormand, J.R.; The Toxicology Research Laboratory, Health and Environmental Sciences The Dow Chemical Company, Midland, MI; Laboratory ID#: DR-0325-7474-007; 6/29/95). XDE-795 (5,7-dichloro-4-[4-flurophenoxy]quinoline; 97.4% pure) was fed in diet to Fischer 344 rats at 0, 5, 20 or 80 mg/kg/day for 1 2 years. XDE-795 was administered for 2 years to 50/sex/dose for chronic/oncogenicity assessment. A satellite group (15/sex/dose) was sacrificed at 12 months (10/sex/dose for interim assessment of chronic toxicity; 5/sex/dose to assess neurotoxicity). NOEL = 20 mg/kg (Females at 80 mg/kg had increased perineal soiling (satellite & main group). Both sexes had decreased bodyweights and bodyweight gains at 80 mg/kg throughout the study. Urea nitrogen was increased in males at 80 mg/kg at 18 and 24 months. Alanine amino transferase (80 mg/kg) was decreased in males at 24 months. Females had cholesterol levels that were statistically significantly increased at 80 mg/kg at 18 and 24 months. Liver and kidney weights (absolute & relative) were statistically significantly increased in both sexes at 80 mg/kg at 12 months. Relative brain weights in both sexes were increased at 80 mg/kg by 24 months. Males had increased absolute and relative testes weights at 80 mg/kg and females had decreased relative heart and increased relative kidney weights at 80 mg/kg at 24 months. There was an increased incidence in chronic progressive glomerulonephropathy in males at 80 mg/kg37 versus 19 in control, p < 0.05.) No adverse effects. Acceptable. M. Silva, 8/21/01
Ref: October 4, 2001. SUMMARY OF TOXICOLOGY DATA QUINOXYFEN (XDE-795 & XR-795). California EPA, Department of Pesticide Regulation, Medical Toxicology Branch.

Tefluthrin - Insecticide - CAS No. 79538-32-2

In a subchronic oral toxicity study, rats were dosed at 0, 50, 150, or 350 ppm (2.5, 7.5, or 17.5 mg/kg/day) for 90 days. The LOEL for this 90-day feeding study is 150 ppm (equivalent to approximately 7.5 mg/kg/day) based on changes in hemoglobin, cholesterol, and liver weight in the mid-dose animals. The NOEL is 50 ppm (equivalent to approximately 2.5 mg/kg/day).
Ref: Federal Register: November 26, 1997. Tefluthrin; Pesticide Tolerance. Final Rule.

Tembotrione - Herbicide - CAS No. 335104-84-2

• In a combined chronic/carcinogenicity study (MRID 46695708) Wistar male rats/dose in the dietat dose levels of 0, 1, 20, 200 or 800 ppm (equivalent to 0, 0.04, 0.79, 8.3 or 31.7 mg/kg bw/day) in the diet for 104 weeks. Total cholesterol concentrations were significantly increased (p≤ 0.01) at 200 and 800 ppm (46 and 52%, respectively), compared to controls during the first 18 months of treatment. The increased total cholesterol concentrations observed at 800 ppm during the first 18 months of treatment were still present after 3 months of recovery (43%, p<0.01), compared to controls (page 71).
• A treatment related increase in cholesterol was observed in males in a dose-dependent manner that reached significance at ≥75 ppm [1.25 ppm (14%), 75 ppm (22%, p<0.01), 1500 ppm (32%, p<0.001), 7000 ppm (80%, p<0.001) and increased significantly by 34% (p<0.01) in females at 7000 ppm (page 55).
Dose and Endpoint for Establishing RfD: (page 22)
------ Study Selected: Chronic Toxicity/Carcinogenicity (Feeding)/Rat MRID No.: 46695708
------ The NOAEL of 0.04 mg/kg/day was based on neovascularization and edema of the cornea and snow flake-like corneal opacity, unilateral or bilateral keratitis of the eye, decreased mean body weight and mean body-weight gain, increased total cholesterol, higher ketone levels and lower pH values, higher protein levels, increased kidney weight, kidney to body weight and kidney to brain weight ratios, chronic nephropathy and atrophy of the sciatic nerve observed in the male at 0.79 mg/kg/day (LOAEL).
------ UF(s): An UF of 100 was applied to account for interspecies extrapolation (10X)
------ Comments about Study/Endpoint/UF: This study provided the lowest NOAEL in the database (most sensitive endpoint) and will also provide the most protective limits for human effects.

Reference: Tembotrione. Human-Health Risk Assessment for Proposed Uses on Field Corn, Sweet Corn and Popcorn. USEPA. September 7, 2007.

Tetraconazole -Fungicide - CAS No. 112281-77-3

-- Chronic toxicity. A 12-month chronic oral toxicity study in Beagle dogs was conducted with technical tetraconazole at dose levels of 0.7, 2.8, and 5.6 mg/kg/day (22.5, 90, and 360 ppm dietary concentrations, respectively). At the highest dose, liver and kidney weights and cholesterol levels were elevated, and liver injury occurred based upon increased levels of GPT, -GT and OCT. The no effect level was 0.7 mg/kg/day, as compared with zero-dose control animals.
Ref: Federal Register: October 14, 1999. Notice of Filing Pesticide Petitions to Establish a Tolerance for Certain Pesticide Chemicals in or on Food. PP 9F5066, 9F6023, and 7E4830.

Thiazopyr - Herbicide - CAS No. 117718-60-2

-- A two year rat carcinogenicity study at doses of 0, 0.04, 4.4, 44.2 or 136.4 mg/kg/day (Males) 0, 0.06, 0.6, 5.6, 56.3 or 177.1 mg/kg/day (female) with a NOEL of 4.4 mg/kg/day. The effects were protruding eyes, evidence of mild anemia, increased GGT and cholesterol, increased absolute and relative liver, kidney and thyroid weights and significant increase in microscopic lesions in the liver (hypertrophy and vacuolar changes), kidney (nephropathy) and thyroid (hypertrophy and hyperplasia); decreased mean body weight and body weight gain and food consumption. A statistically significant increase in thyroid follicular cell adenomas/cystadenomas were observed in males at 44.2 and 136.4 mg/kg/day. A nonsignificant increase in renal tubular adenomas in high-dose females was considered to be equivocal.
Ref: US EPA. Pesticide Fact Sheet. Thiazopyr Reason for Issuance: Registration of a New Chemical Date Issued: February 20, l997.

Transfluthrin - Insecticide - CAS No. 118712-89-3

-- In 2 yr studies the NOEL for non-neoplastic findings in the rat was 20 ppm (1 mg kg d) based on efffects in the kidney (increased organ weight, pigment deposition and glomerulonephrosis) at 200 ppm and above). In the mouse, the NOEL was 10 ppm in males (based on increases in liver weight, hepatocyte hypertrophy at 1000 ppm and fluoride accumulation at 100 ppm). It was not possible to set a NOEL for females as increases in serum cholesterol, protein and albumin were reported at the lowest dose.
-- In 90 d study Beagles (4/sex/group) were administered transfluthrin (94.5%0 pure via their food at nominal concentrations of 0, 50, 350 or 2500 ppm. Haematological and urine examinations were carried out on all grops pre study and at 3, 6 and 13 w. Ophthalmological examinations were carried out pre study, 6 and 13 w, and hearing tests were carried out pre study and 13 w. ... The haematological and urine examinations showed no treatment related changes. The clinical chemistry examination indicated treatment related effects on the liver. At 2500 ppm increases in cholesterol levels were noted in both sexes which increased with time (~ 35-70% in males and ~ 60-80% in females over `- 13 w). In addition at 13 w plasma lipid and triglyceride levels were increased in both sexes (~ 110-120%). N-demethylase activity was increased in both sexes at 2500 ppm (~ 35%). At 13 w the examination also noted a decrease in thyroxine levels in females (~ 45%) and a non-significant decrease in triiodothyronine (~ 40%) at 2500 ppm. At necropsy, gross pathological examination noted no treatment related changes. At 2500 ppm relative (to the brain) liver weights increased in both sexes (~ 30% in males and ~50% in females) and thyroid weight increased non-significantly in females (~ 70%). Histopathological examination showed centrilobular hypertrophy in all animals at 2500 ppm and 1 female from this group with minimal hepatocytic single cell necrosis. The NOEL for this study was 50 ppm (1.9 kg d) based on the increase in N-demethylase activity in males at 350 ppm (14 mg kg d).
-- B6C3F1 mice (60/group/sex) received 0, 10, 100 or 1000 ppm mg kg transfluthrin (94.8-95%) pure in the diet for up to 104 weeks with 10/sex/dose killed after one yar. Two additional groups(10/sex) received 0 or 1000 ppm for 13 weeks... Serum cholesterol levels were significantly raised from 13 weeks at 1000 ppm (20% in males and 54% in females) and from 100 ppm from week 53 (approximately 11 - 30%) and at week 103 from 10 ppm in females (approximately 50 - 70%) and at 1000 ppm in males )~ 20%). ... Based on the chronic toxicity, in males the NOEL is 10 ppm (2 mg kg d based on increases in liver weight and hepatocyte hypertrophy, at 1000 ppm and increased fluoride accumulation at 100 ppm). It is not possible to set a NOEL for females as increases in serum cholesterol, protein and albumin were reported at the lowest dose.
Ref: Evaluation on: Transfluthrin Use as a Public Hygiene Insecticide. September 1997. Prepared by: the UK Health and Safety Executive, Biocides & Pesticides Assessment Unit, Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ. Available from: Department for Environment, Food and Rural Affairs, Pesticides Safety Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York YO1 7PX. UK. Also a

Note: This was transcribed from the copy available on the web. While one can easily read this report on the web, the report is inaccessible, or locked, to any attempt to copy it. Any errors are mine. EC.

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