15-Jun-12Test TypeReport #Test SystemCommentsResultsAcute Oral (LD50)RatGLP;GuidelineThe rat oral LD50 was greater than 5000 mg/kg (limit dose). There were no deathsduring the exposure recovery period.Acute Inhalation (4-hr LC50)Rat, whole-bodyGLP;NotGuidelineThe male and female rat, whole-body inhalation 4-hr LC50 was greater than 15,000ppm (the highest achievable vapor concentration). There were no deaths during the exposureor recovery period. Anesthetic effects were observed at concentrations greater than or equalto 9700 ppm.Acute Dermal (LD50)RatGLP;GuidelineThe rat dermal LD50 was greater than 5000 mg/kg (limit dose). There were nodeaths during the exposure recovery period.Dermal IrritationRabbitGLP;Guidelinewas not a dermal irritant when tested in rabbits. No clinical signs of toxicity wasobserved in the study.Dermal SensitizationMouseGLP;Guidelinewas not a dermal sensitizer when tested in mice. No clinical signs of toxicity wasobserved in the study.Eye IrritationRabbitGLP;Guidelinewas not an eye irritant when tested in rabbits. No clinical signs of toxicity wasobserved in the study.Bacterial Reverse Mutation Assay (Ames)BacteriaGLP;Guidelinewas not mutagenic in the Bacterial Reverse Mutation Assay (Ames) test usingSalmonellastrains TA98, TA100, TA1535, and TA1537 andE. colistrain WP2uvrA eitherin the presence or absence of an S9-activated test system.In Vitro Chomosome AberrationChinesehamster ovary(CHO) cellsGLP;Guidelinedid not produce structural or numerical chromosome aberrations in anin vitromammalian chromosome aberration test using Chinese hamster ovary (CHO) cells either inthe presence or absence of an S9-activated test system.In Vivo MicronucleusRatGLP;GuidelineMale and female rats were exposed to a single oral dose of 0, 500, 1000, or 2000 mg/kg. No clinical signs of toxicity or mortality was observed in the study. HFX-110 did notinduce biologically relevant increases in micronucleated reticulocytes in peripheral bloodcells.28-Day OralRatGLP;GuidelineMale and female rats were exposed to 0, 250, 500 or 1000 mg/kg via oral gavagefor 28 days. No test substance-related adverse effects were observed in clinical or anatomicalpathology assessments. The no-observed-adverse-effect level (NOAEL) was 1000mg/kg/day.28-Day Oral with FOB(a)RatGLP;GuidelineMale and female rats were exposed to 0, 100, 250, or 1000 mg/kg via oral gavagefor 28 days. No test substance-related adverse effects were observed in clinical,neurobehavioral, or anatomical pathology assessments. The no-observed-adverse-effect level(NOAEL) was 1000 mg/kg/day.Completed Studies90-Day Oral with FOBRatGLP;GuidelineMale and female rats were exposed to 0, 250, 500 or 1000 mg/kg via oral gavagefor 90 days. No test substance-related adverse effects were observed in clinical,neurobehavioral, or anatomical pathology assessments in females. A slight increase inseverity, but not incidence, of chronic progressive nephropathy (CPN) and associated clinicalpathology changes was observed in males at all dose levels. The no-observed-adverse-effectlevel (NOAEL) for female rats was 1000 mg/kg/day. The NOAEL was not determined formale rats.Pre-natal Oral DevelopmentalRatGLP;GuidelineFemale rats were exposed to 0, 250, 500, or 1000 mg/kg per day via oral gavageduring gestation day (GD) 6-20. No test substance-related maternal or developmental toxicitywas observed at any dose level. The no-observed-adverse-effect level (NOAEL) for maternaland fetal effects was 1000 mg/kg.Intravenous Tolerability StudyRatNot GLP;NotGuidelineMale and female rats were exposed to to a single intravenous injection of 0, 1, or 5 mg/kgNo deaths, clinical signs, or body weight losses occurred in any animal after 4days of observation.Ready Biodegradability(b)NAGLP;Guidelineis not readily biodegradable. No transformation product was generated under theconditions of the test.Bioconcentration Study(b)FishGLP;GuidelineMedaka were exposed to 0.005 or 0.05 mg/L in a continuous flow-through dilutionsystem for 60 days followed by a 14-day depuration period. The steady-state BCF valuesranged from 1100 to 2210 for the 0.05 mg/L level and from 1560 to 2850 for the 0.005 mg/Llevel. The concentration of in the fish decreased with time during the depurationperiod. The biological half-lives ranged from 3.1 to 6.6 days for the 0.05 mg/L level and from2.5 to 4.7 days for the 0.005 mg/L level. Average BCF for 12 datapoints = 1990±460.Algae Growth Inhibition Test(b)Green algaeGLP;GuidelineThe green algae 72-hr ErC50 was greater than 0.000477 mg/L (the highestconcentration tested). The no observed effect concentration (NOECr) at 72 hours was0.000477 mg/L (the highest dose tested). The concentration was the time-weighted mean ofthe limit of solubility (0.16 mg/L) after 72-hours. During the course of the study, it wasdetermined that the test substance was volatilized from the test solutions due to a largeHenry's law constant of 4.75E6 m3/mol.Algae Growth Inhibition TestGreen algaeNot GLP;NotGuidelineThe green algae 72-hr ErC50 was greater than 120 mg/L (the highest concentrationtested).Fish Acute Toxicity Test(b)MedakaGLP;GuidelineThe Medaka 96-hr LC50 was greater than 0.0.960 mg/L (the highest concentrationtested). The concentration was the time-weighted mean of the limit of solubility (0.1 mg/L)after 96-hours. The test solution was renewed every 24 hours.Fish Acute Toxicity TestFatheadMinnowNot GLP;NotGuidelineThe fathead minnow 96-hr LC50 was greater than 120 mg/L (the highestconcentration tested).Daphnia Acute Immobilization Test(b)DaphniamagnaGLP;GuidelineThe Daphnia magna 48-hr EC50 was greater than 0.157 mg/L (the highestconcentration tested). The concentration was the time-weighted mean of the limit ofsolubility (0.17 mg/L) after 48-hours. The test solution was renewed after 24 hours.Daphnia Acute Immobilization TestDaphniamagnaNot GLP;NotGuidelineThe Daphnia magna 48-hr EC50 was greater than 120 mg/L (the highestconcentration tested).Activated Sludge Respiration Inhibition TestMicrobialGLP;GuidelineThe microbial respiration inhibition EC50 was greater than 1000 ppm (highest dosetested). No inhibition was noted at any concentration.Adsorption Coefficient (Log Koc)NAGLP;GuidelineThe study was conducted using the HPLC Method for determining a substance's absorptioncoefficient (soil organic carbon/water) on soil and sewage sludge. The adsorption coefficient(log Koc) value of the test substance was calculated to be 4.50 on soil and 4.43 on sewagesludge.LogKow (modelled)NANot GLP;NotGuidelineKOWWIN v1.68 was used to estimate LogKow. components failed to satisy thetraining set's structural domain requirements completely, however, other evidence by way ofrelated analogues and water solubility information provide corroborating evidence that theestimates made by the model are reasonable. LogKow prediction ranged from 4.57 to 5.22for A weighted average based on the typical component percentages and theirestimated LogKow values was calculated to be approximately 4.97.Daphnia Reproduction Test(c)DaphniamagnaGuidelinein progress, report expected 15-JuneZebrafish 14-day Growth Study(c)Zebrafish Guidelinein progress, report expected end of MayEarthworm Acute Toxicity Test(c)EiseniafoetidaGuidelineThe Eisenia foetida 14-day LC50 was greater than 1000 mg/kg dry soil (the highestand only concentration tested).in progress, report expected end of MayInherent Biodegradability Test(d)NAGLP;Guidelineis inherently biodegradable.Biodegradation was 44.3% after 28 days under theconditions of the test.in progress, report expected end of MayToxicokinetics Test(e)RatNot GLP;NotGuidelinependingLogKow (measured)(b)NA GuidelinependingOn-going Studies HFX-110