15-Jun-12

Test Type Report # Test System Comments Results

Acute Oral (LD50) Rat GLP; Guideline The rat oral LD50 was greater than 5000 mg/kg (limit dose). 

during the exposure recovery period. 

Acute Inhalation (4-hr LC50) Rat, whole- body GLP; Not Guideline The male and female rat, whole-body inhalation 4-hr LC50 w

ppm (the highest achievable vapor concentration). There were no deathor recovery period. Anesthetic effects were observed at concentrations to 9700 ppm.

Acute Dermal (LD50) Rat GLP; Guideline The rat dermal LD50 was greater than 5000 mg/kg (limit dos

deaths during the exposure recovery period. 

Dermal Irritation Rabbit GLP; Guideline was not a dermal irritant when tested in rabbits. No clinical 

observed in the study.

Dermal Sensitization Mouse GLP; Guideline was not a dermal sensitizer when tested in mice. No clinical 

observed in the study.

Eye Irritation Rabbit GLP; Guideline was not an eye irritant when tested in rabbits. No clinical sig

observed in the study.

Bacterial Reverse Mutation Assay (Ames) Bacteria GLP; Guideline was not mutagenic in the Bacterial Reverse Mutation Assay 

Salmonella strains TA98, TA100, TA1535, and TA1537 and E. coli st

in the presence or absence of an S9-activated test system.

In Vitro Chomosome Aberration

Chinese 

hamster ovary 

(CHO) cells

GLP; 

Guideline

 did not produce structural or numerical chromosome aberrati

mammalian chromosome aberration test using Chinese hamster ovary (the presence or absence of an S9-activated test system.

In Vivo Micronucleus Rat GLP; Guideline

Male and female rats were exposed to a single oral dose of 0, 500, 1000

. No clinical signs of toxicity or mortality was observed in the stud

induce biologically relevant increases in micronucleated reticulocytes icells.

28-Day Oral Rat GLP; Guideline

Male and female rats were exposed to 0, 250, 500 or 1000 mg/kg for 28 days. No test substance-related adverse effects were observed in pathology assessments. The no-observed-adverse-effect level (NOAELmg/kg/day.

28-Day Oral with FOB (a) Rat GLP; Guideline

Male and female rats were exposed to 0, 100, 250, or 1000 mg/kg for 28 days. No test substance-related adverse effects were observed in neurobehavioral, or anatomical pathology assessments. The no-observ(NOAEL) was 1000 mg/kg/day.

Completed Studies 

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90-Day Oral with FOB Rat GLP; Guideline

Male and female rats were exposed to 0, 250, 500 or 1000 mg/kg for 90 days. No test substance-related adverse effects were observed in neurobehavioral, or anatomical pathology assessments in females. A sseverity, but not incidence, of chronic progressive nephropathy (CPN) pathology changes was observed in males at all dose levels. The no-oblevel (NOAEL) for female rats was 1000 mg/kg/day. The NOAEL wamale rats.

Pre-natal Oral Developmental Rat GLP; Guideline

Female rats were exposed to 0, 250, 500, or 1000 mg/kg per during gestation day (GD) 6-20. No test substance-related maternal or 

was observed at any dose level. The no-observed-adverse-effect level (and fetal effects was 1000 mg/kg.

Intravenous Tolerability Study Rat

Not GLP; 

Not 

Guideline

Male and female rats were exposed to to a single intravenous injection 

 No deaths, clinical signs, or body weight losses occurred in 

days of observation. 

Ready Biodegradability (b) NA GLP; Guideline is not readily biodegradable. No transformation product was 

conditions of the test.

Bioconcentration Study (b) Fish GLP; Guideline

Medaka were exposed to 0.005 or 0.05 mg/L in a continuous system for 60 days followed by a 14-day depuration period. The steadyranged from 1100 to 2210 for the 0.05 mg/L level and from 1560 to 28level. The concentration of in the fish decreased with time d

period. The biological half-lives ranged from 3.1 to 6.6 days for the 0.2.5 to 4.7 days for the 0.005 mg/L level. Average BCF for 12 datapoint

Algae Growth Inhibition Test (b) Green algae GLP; Guideline

The green algae 72-hr ErC50 was greater than 0.000477 mg/concentration tested). The no observed effect concentration (NOECr) a0.000477 mg/L (the highest dose tested). The concentration was the timthe limit of solubility (0.16 mg/L) after 72-hours. During the course of determined that the test substance was volatilized from the test solutionHenry's law constant of 4.75E6 m3/mol.

Algae Growth Inhibition Test Green algae

Not GLP; 

Not 

Guideline

The green algae 72-hr ErC50 was greater than 120 mg/L (the tested).

Fish Acute Toxicity Test (b) Medaka GLP; Guideline The Medaka 96-hr LC50 was greater than 0.0.960 mg/L (the 

tested). The concentration was the time-weighted mean of the limit of after 96-hours. The test solution was renewed every 24 hours.

Fish Acute Toxicity Test Fathead Minnow Not GLP; Not Guideline The fathead minnow 96-hr LC50 was greater than 120 mg/L 

concentration tested).

Daphnia Acute Immobilization Test (b) Daphnia magna GLP; Guideline The Daphnia magna 48-hr EC50 was greater than 0.157 mg/L 

concentration tested). The concentration was the time-weighted mean solubility (0.17 mg/L) after 48-hours. The test solution was renewed a

Daphnia Acute Immobilization Test Daphnia magna Not GLP; Not Guideline The Daphnia magna 48-hr EC50 was greater than 120 mg/L 

concentration tested).

Activated Sludge Respiration Inhibition Test Microbial GLP; Guideline The microbial respiration inhibition EC50 was greater than 1

tested). No inhibition was noted at any concentration.

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Adsorption Coefficient (Log Koc) NA GLP; Guideline

The study was conducted using the HPLC Method for determining a sucoefficient (soil organic carbon/water) on soil and sewage sludge. The (log Koc) value of the test substance was calculated to be 4.50 on soil asludge.

LogKow (modelled) NA

Not GLP; 

Not 

Guideline

KOWWIN v1.68 was used to estimate LogKow. componentraining set's structural domain requirements completely, however, otherelated analogues and water solubility information provide corroboratinestimates made by the model are reasonable. LogKow prediction rangefor A weighted average based on the typical component perestimated LogKow values was calculated to be approximately 4.97.

Daphnia Reproduction Test (c) Daphnia magna Guideline in progress, report expected 15-June

Zebrafish 14-day Growth Study (c) Zebrafish Guideline in progress, report expected end of May

Earthworm Acute Toxicity Test (c) Eisenia foetida Guideline The Eisenia foetida 14-day LC50 was greater than 1000 mg/k

and only concentration tested). in progress, report expected end of May

Inherent Biodegradability Test (d) NA GLP; Guideline is inherently biodegradable. Biodegradation was 44.3% after 

conditions of the test. in progress, report expected end of May

Toxicokinetics Test (e) Rat

Not GLP; 

Not 

Guideline

pending

LogKow (measured) (b) NA Guideline pending

On-going Studies HFX-110

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