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Completed and Ongoing Studies of the PMN Substance

[                                                                          ]

Sample

Number

Study Type

(species) Report Number Endpoint / LC50 /NOAEL / LOAEL

Results  

or

Location / Expected Completion

[             ]

4‐hr inhalation LC50

– key study

(rat)

[                                 ] 4‐hr LC50 > 17,000

ppm

Groups of 5 male and 5 female

Crl:CD®(SD IGS) rats were exposed via

whole‐body inhalation exposure for up

to 4 hours to target concentrations of

17,000 and 25,000 ppm [                           

].  Rats displayed violent convulsions

after an 8‐minute exposure to

approximately 23,000 ppm (mean

chamber concentration), and therefore

the exposure was terminated for

humane reasons. No convulsions or

mortality were observed at 17,000 ppm.  

Under the conditions of this study, the 4‐

hour LC50 was greater than 17,000

ppm.  

        

[             ]

4‐hr inhalation LC50

(rat)

[                                 ]

4‐hr LC50 > 25,400

ppm and < 49,000

ppm

Groups of 5 male and 5 female

Crl:CD®(SD IGS) rats were exposed via

nose‐only inhalation exposure for up to

4 hours to 15,000, 24,000, 50,000 or

125,000 ppm [                           ].  Severe

clinical signs and/or mortality were

observed in animals exposed to

concentrations of 49,000 and 122,000

ppm for 4 and 20 min, respectively. At

25,400 ppm, there was 1 death during

dosing, clinical signs of toxicity, and

initial body weight loss post 4‐hr

exposure. No adverse effects were

observed in animals exposed to 14,600

ppm for 4 hours. Based on the findings,

the 4‐hr LC50 was estimated to be

between 25,400 ppm and 49,000 ppm.

[             ]

1‐hr inhalation

Approximate Lethal

Concentration (ALC)

(rat)

[                                 ] 1‐hr ALC > 24,000

ppm

5 male Crl:CD(SD) rats were exposed to

24,000 ppm [                           ] via whole‐

body inhalation for approximately 1

hour.   There were no deaths during the

exposure or 14‐day recovery period.  

During exposure, the rats exhibited

labored breathing and decreased activity

levels. No clinical signs of toxicity were

observed in any rat during the recovery

period.  Under the conditions of this

study, the 1‐hour ALC was greater than

24,000 ppm.

[             ]

10‐minute

inhalation screen

(rat)

[                                 ] LOAEL = 33,000 ppm

2 male and 2 female Crl:CD(SD) rats

were exposed to 33,000 ppm [                       

] via whole‐body inhalation for

approximately 10 minutes.   There were

no deaths during the exposure or 14‐day

recovery period.  Under the conditions

of this study, 10 minutes of exposure to

33,000 ppm of [                          ]produced

tremors, muscle spasms, convulsions

and decreased activity levels during the

exposure.

[             ]

Cardiac

sensitization [                                 ]

NOAEL = 70,000 ppm

LOAEL = > 70,000

ppm

A predetermined epinephrine dose at

which there was a clear but minimal

effect on the ECG was determined for
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(dog) each group of up to

6 Beagle dogs.  

Groups of dogs were exposed to 70,000,

80,000, or 90,000 ppm[                           ]

via muzzle‐only inhalation.  Two of the6

animals exposed to 70,000 ppm[                  

] displayed continuous convulsions,

excessive salivation, and/or dilated

pupils following test substance

exposure.  Only one animal in each of

the 80,000 and 90,000 ppm exposure

groups were exposed as they displayed

continuous convulsions, excessive

salivation, and/or dilated pupils during

the exposure.  The cardiac sensitization

NOAEL in epinephrine challenged dogs

was 70,000 ppm.  Higher concentrations

could not be fully evaluated as the

presence of adverse clinical effects

precluded the administration of the

epinephrine challenge.

[             ]

Bacterial Reverse

Mutation Assay

(Ames)

(Bacteria ‐ 

S. typhimurium)  

[                                 ] Negative

[                           ] was not mutagenic in

the Bacterial Reverse Mutation Assay

(Ames) test using Salmonella strains

TA98, TA100, TA1535, and TA1537 and

E. coli strain WP2 uvrA with and without

S9 activation.

[             ]

In vitro

chromosome

aberration

(human

lymphocytes)

[                                 ] Negative

[                           ] did not produce

structural or numerical chromosome

aberrations in an in vitro mammalian

chromosome aberration test using

human peripheral blood lymphocytes

either in the presence or absence of S9‐

activated test systems.

[             ]

In vivo

micronucleus

(rat)

[                                 ] Negative

The micronucleus study was conducted

as part of the 28‐day inhalation in rats.  

The test substance was negative for

adverse effects in the in vivo

micronucleus test.

[             ]

28‐day inhalation

(rat)

[                                 ] NOAEL

= 10,000 ppm

LOAEL= 15,000 ppm

Groups of 10 male and 10 female Wistar

rats were exposed to 0, 1000, 10,000, or

15,000/20,000 ppm[                           ]  

via nose‐only inhalation for6 hours per

day,5 days per week for4 weeks.   The

top exposure concentration was

dropped to 15,000 ppm after the first

week of exposure due to the premature

death of two males during the 3rd day of

exposure and moderate body weight

loss in several males in this group.  At

day 23 of exposure,2 more males died

during the last hour of exposure in the

15,000 ppm group.  In total, four male

animals died during the treatment

period.  The cause of these deaths could

not be established.  Body weight gain

was dose‐dependently reduced in males

of the mid and high exposure groups

during the treatment period.  Recovery

was noted thereafter.  In addition,

transient body weight loss was noted in

females of the high exposure group.  No

test substance‐related adverse effects

were observed in micronucleus, clinical,

neurobehavioral, or gross and

anatomical pathology assessments.  

Based on the mortality in the high

exposure group, the no‐observed‐
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adverse‐effect level (NOAEL) was

10,000 ppm.

        

[             ]

In vitro CHO HGPRT

(CHO cells)

[                                 ]    [                                 ]

[             ]

Algae Growth

Inhibition Test

(Green algae ‐ 

Pseudokirchneriella

subcapitata)

    [                                 ]

[             ]

Fish Acute Toxicity

Test

(Medaka ‐  

Oryzias latipes)

    [                                 ]

[             ]

Daphnia Acute

Immobilization Test

(Water Flea ‐ 

Daphnia magna)

[                                 ]

[             ] Ready

Biodegradability     [                                 ]

[             ] Hydrolysis as a

function of pH     [                                 ]

[             ] Partition Coefficient

(Log Kow) [                                 ]    [                                 ]