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BT Study Number: B04109

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After the classification, an Identification card (stated test no ., group/dose, individual no .,

sex, administration route, administration period, date of necropsy and etc .) was attached

on a cage . To identify between animals, their tails were labeled using an oil base magic

pen in accordance with the method of identification (SOP/SGE/140) .

4 . Experimental conditions

(1) Room No. A319

(2) Type and size of a cage

The animals were housed individually in stainless steel wire cages (A polycarbonate cage

(260W X 420L x 180H (mm), Deajong machinery )

(3) Number of animals in a cage

8-9 (quarantine and acclimatization period)/6(main test)

(4) Temperature 21.26 - 22 .44 'C

(5) Relative humidity 43.73 - 50 .78 %

(6) Method of ventilation and frequency 10--15/hr,

(7) Artificial lighting : the sequence being 12 hours light (a .m. 7 :00-p.m. 7 :00) and 12

hours dark (p.m . 7 :00-a.m . 7 :00)

(8) Illumination intensity 150 - 300 Lux

(9) Rinsing and sterilization of breeding materials and animal roo m

A 500 fold solution of alkali surface active agent (Ultra-Clean Neighbour-PC,

NE-SARANG CO .,Ltd.) and 2500 fold solution of surface active aQent (Ultra-Clean

Neighbour-RM300, NE-SARANG Co .,Ltd .) will be used for rinsing~a cage ; and high

pressure steam will be used for a sterilization . A Cage, water supply bottle, and fodder

supplier will be replaced after the acclimatization period .

After the daily work, Pacorn-A (the principal element: 200 fold Octyldecyl dimethyl

ammonium chloride, SAMU MEDIAN Co ., Ltd .), MiKro-Quat (the principal element :

400 fold Alkyldimethylbenzyl ammonium chloride, Ecolab), and Bromo-sept (the

principal element : 300 fold Di-decyl di-methyl ammonium bromide, DAE STUNG

MICROBIOLOGICAL LABS . Co . . Ltd.) solutions will be used to sterilize the animal

room. Each antiseptic solution will be replaced every 10 days.

5 . Analysis of contaminant in diet and H ate r

(1) Diet Animals were provided ad libitirn; with experimental rodent diet 5057

(2) Supplier

Title Agri Brands Purina Korea, In c

Address 627 Jangdang-dong . Pveonataek-si, Gveongoi-do, Korea P,

(3) Method and amount of fodder si .ipph~ oor1402
p. 2

BT Study Number: B0410 9

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Solid fodder will be supplied freely through the fodder supplier during the study .

(4) Analysis of compound and contaminant in the fodder.

A certificate of analysis for the fodder was received from the Analysis Service of Central

Laboratory of Purina Korea Inc . (627 Jangdang-Dong Pyongtaek Kyeonggi-Do Korea)

then the tolerance level of contaminant (Biotoxtech standard) was verified.

6 . water

(1) Type

Purifieded water using a filter and sterilizer was provided .

(2) Method of water supply

Purified water in a polycarbonate bottle (500 mLl was freely supplied .

(3) Analysis and validation of compound and contaminant in drinking wate r

Drinking water was collected at the fixed place by Biotoxtech, in which composition

was analyzed by Chung Buk Institute of Health and Environment Research (140-50

Songjeong-Dong, Chungju-si Chungcheongbuic-Do Korea) in accordance with a

'Regulation of Quality Criteria for Potable Water and Testj (Ministry of Environment

Ordinance No . 122, 2002). Finally, every test item was evaluated whether they was in

the tolerance level or not .

7 . Preparation and analysis of test substance

(1) Vehicle and reason for selection

0 .5% MC 1500 was used, in which it was kept 4°C . This test item was recommended

by the sponsor.

(2) Preparation of test item

The test item was dissolved in 0 .5°ro MC 1500 0 make a stock solution and was further

diluted for lower concentrations.

(3) Preparation of the positive contro l

MMC was dissolved in Water for injection .

(4) Formulation stability, homogeneity and concentration analvsi s

1~ Stability No visible generation of heat, coloring and foaming

OZ Homogeneity The test substance was homogeneously dissolve d

OO Concentration analysis Not done .

8. Administration

(1) Rout e

Oral administration P,-3 97 1 064 03
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BT Study Number: B04109

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(2) Reason for selection

Expected clinical application route for the test item was considered .

(3) Injection method

The test item and negative control were administrated by gavage ; and the positive control

was by Intraperitoneal .

9 . Test group

Dose Dosage Treatment Animal no

Group Route volume times

(mg/kg ) (Identification No.)

(mL/k2) (No .)

.G1 Control 0 P.O. 10 2 6(1M01 - 1M06)

G2 Low dose 500 P.O . 10 2 6(2M07 - 2M1 2)

G3 Middle dose 1000 P .O . 10 2 6(3M13 - 3M18)

G4 High dose 2000 P.O. 10 2 6(4M19 - 4M24)

Positive

G5 control 2 I.P . 10 2 6 (5M25 - 5M30)

The dose range-finding study was conducted in 5 dose levels (125, 250, 500, 1000, and

2000 mg/kg). As a result, 2000 mg/kg was selected as the highest dose level of the main

study because it did not show signs of toxicity . In addition, middle and low dose level for

the main test were selected as 1,000 and 500 mg/kg, respectively . The negative control

and positive control were 0 .5% MC and MMC, respectively . The closing volume of the test

substance was 10 ml/kg .

10. Observation, measurement and examination

(1) General signs

All animals were observed once daily for appearance, moribund and mortality .

(2) Body weight

Individual body weights were recorded just before the administration and before the

day for collection of the bone inarrows .

11 . Collection of bone marrow ~'00404

The dose range-finding study (Appendix 3) was carried out to determine an appropriate

time for collection of the bone mariow cells at time of 16, 24 . 48 and 7 2 hours after the

%~~~~~ treatment. In results, microrucleated polychromatic ervthrocytes (ti'INPCEs) were not
p. 4

BT Study Number: B04109

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increased. Therefore, collection was done at time of 24 hour after the treatrr.ent.

12 . Collection of the bone marrow and preparation of micronucleus specimen s

As a MNPCEs were not increased in the preliminary study to determine an appropriate

time for collection of the bone marrow cells . To collect the bone marrow cells, mice

were euthanized by dislocation of cervical vertebrae after that a 0.2mL of fetal bovine

serum (Hyclone, USA) was ran through an extracted femur using a 1 mL disposable

syringe with needle and collected . Finally, collected samples were centrifuged (MICRO

17TR, Hanil science industrial) at 1,000 rpm for 5 min . The supernatant was discarded

and the cell pellet was mixed well and then smeared on the slide glass . Two specimens

per animal were produced, in which they were air-dried and stained with a 5 % Giemsa

solution for 30 minutes.

13. Observation, measurement and examination

(1) Observation of specimen s

Each specimen was observed by the microscope (BX5 1, Olympus, Japan)with a

magnification of 1,000 . To calculate the proportion of PCE in the total erythocytes

[PCE/(PCE+NCE)], sum of polychromatic erythrocyte (PCE) and normochromatic

erythrocyte (NCE) should be 1000; and to calculate MI`TCE in the Micronucleated

Polychromatic erythrocyte [MNPCE/(1000PCE)], polychromatic erythrocyte (PCE)

were counted as 2000 .

(2) Evaluation of contro l

According to the criteria of the CRC handbook of tociology (1995 by CRC Press, Inc), a

negative control was judged, if MNPCE/(1000PCE) were between 0 and 8 ; and if

MNPEC/(1000PCE) was increased as compared with that of the negative control, it was

a positive control . .

(3) Judgment criteri a

It was judged as a positive when Mi~'PCEs was increased significantly in

dose-dependent manner or there was reproducible increase in number of M NT PCE at

least one test level .

14. Statistics analysis

We conducted the t-test and ANOVA test for an appearance of micronucleus and body

weight change with 5 % significant level in P value statistically.

000405
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IV. RESULT S

(1) Mortality and clinical sign s

There were no dead animal and no clinical signs in the treatment groups just after the

treatment.

(2) Change of body weight (Table 1& Appendix 1 )

There was no significant body weight change for all test groups during the test period .

(3) Frequency of MNPCE induction (Table 2 & Appendix 2)

The frequency of MNPCE induction per 1,000 PCE was 0 .3, 0.8, 0 .8, and 1 .2 for the

negative control group, 500, 1000, and 2000 mg/kg of treatment group, respectively,

therefore, there was no significant induction of micronucleus in terins of the test item.

However, the frequency of M.NPCE induction in the MMC treatment group (positive

control group) was average 81 .2, thus, there was significant increase as compared with

that of the control group(p<0 .01).

The proportion of [PCE/(PCE+NCE)], criterion of cytotoxicity, in following dose levels 0

(negative control)., 500, 1000, 2000 mg/kg and positive control (MMC) were 0 .498, 0 .499,

0 .495, 0.501 and 0.499, respectively . There was no significant difference between the

treatment and control groups.

a ;4 0 Co

0()0406
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BT Study Nmnber : B04109

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V. DISCUSSIONS AND CONCLUSION S

The objective of this study was to determine a mutagenic potential of . ~

in the micronuc'eus assay system using bone marrow cells in

mice.

The serial concentrations of the test item, ~

]such as 500, 1000 and 2000 mg/kg were administered by gavages to six male

mice/group. Water for injection, 10 mL/kg, was also administered by gavages to negative

control group and 2 mL/kg of Mitomycin C was administered by intraperitoneal to positive

control group. In 24 hour after the treatment, all mice were sacrificed then bone marrow

cells in thigh were collected . The Slides containing the bone marrow cells were stained with

5% Giemsa solution . The frequency of micronucleus induction was observed by a

microscope.

As a result, there was no significant difference in terms of frequency of MNPCE induction

between all the test groups treated wit h

and the negative control group .

In the positive control group, Frequency of Mi~TPCE induction was increased significantly in

contrast with that of the negative control group .

The proportion of [PCE/(PCE+NCE)] was no significant difference between the treatment and

control groups.

Therefore, the test item, did not show

the induction of micronuclei in mice under the condition of this study .

t?00407
p. 7

BT Study Number: B04109

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VI. REFERENCES

CRC handbook of toxicology(1995 by CRC Press, Inc )

n! 4 02
p. 8

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TABLE S

0 ~~.G'4 0a~~si

(.) ()0409
p. 9

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Tablel . Change of body weight(Group Summary )

Hours after Groups G1 G2 G3 G4 G5

treatment Dose(mg/kg) 0 500 1000 2000 2

Mean 35.3 35.3 35 .3 35.3 35. 3

0 S.D . 1.1 0.9 0.9 0.8 0.8

N 6 6 6 6 6

Mean 35.1 34.9 34.7 34.6 33 . 3

24 S.D . 1.1 1 .2 0.8 0.7 0.5

N 6 6 6 6 6

G1 0 .5% MC (0 mg/kg, P .O . )

G2 :

G3 :

G4 :

G5 : Mitomycin C (2 mg/kg, I .P .)

N Number of animals examined

e L 1.6

000410
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BT Study Number : B04109

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Table 2 . In vivo Micronucleus test ofC 7in

male ICR mice ( Group summary)

Dose Sampling MNPCE/ PCE/(PCE+NCE) Groups Test items N Route 1000PCE

(mg/kg) time ( hr) (Mean±S .D .)

(Mean±S .D . )

G1 0.5% MC1500 0 6 P.O . 24 0.3± 0 .3 0.498 ± 0 .006

G2 500 6 P.O . 24 0.8 t 0 .4 0.499 t 0 .005

G3 1000 6 P.O . 24 0.8f 0 .6 0.495f 0 .004

G4 J 2000 6 P.O . 24 1 .2t 0 .4 0.5C1 ± 0 .006

G5 Mitomycin C 2 6 1 . P . 24 81 .2 ± 5 .6* 0 .499 -± 0 .003

MC 1500 Methylcellulose 150 0

N : Number of ani-nals examine d

MNPCE : Micronucleated polychromat i c e rythrocyte

PCE : Polychromatic e rythrocyte

NICE Normochromatic e rythrocyte

* : Significantly different from mice treated with vehicle (P<0 .01 , t-Test)

000411
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BTSludy Number: B04109

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APPENDICES

~of;

0C► n412
p. 12

BT Study Number: B04109

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Appendix 1 . Chance of body weight (ind;v dual, N=6)

Body weight (g) at the time

Groups Test items Dcse Animal I .D . of

(mg/k0) Administration Sacrifice

1 M01 33.8 34.3

1 M02 34.8 34.5

1 M03 34.8 35. 2

G1 0.5% Methylceilulose 1500 0 i M04 35

.7 34.1

1 M05 35.8 35.1

1 M06 37.0 37.1

Mean 35.3 35.1

S.D . 1.1 1.1

2M07 34.2 33.1

2'VI08 34.7 34.1

2M09 34.9 36. 0

G2 500 2M10 35.5 34.9

2M1 1 36 .0 35.0

2M12 36.8 36.2

Mean 35.3 34.9

S .D . 0.9 1.2

3M13 34.3 33.8

3M14 34.6 33.7

3M15 34.9 35. 0

G3 1000 3M16 35.1 35.4

3M1 7 36.0 35.4

3M1 8 36 .8 34.8

Mean 35.3 34.7

S .D . 0.9 0.8

4M19 24.4 33.7

4M20 34 .6 34.3

4M21 34 .9 34. 5

G4 2000 4M22 35.1 34.3

4M23 36.1 35.5

4M24 36.5 35. 4

- Mean 35.3 34.6

S .D . 0.8 0.7

5M25 34.5 33.2

5M26 34.5 33.0

5M27 34.9 33. 5

G5 Mitomycin C 2 5M28 35.1 32.5

5M29 36.1 33.8

5M30 36.4 33.5

Mean 35.3 33.3

S . D . 0.8 0.5

N Number of animals examined U 11) 7 ;liP'Q~413
p. 13

BT Study Number: B04109

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Appendix 2 . In vivo Micronucleus test of ~ In

male ICR mice (Individual, N=6 )

Groups Test items Dose Route Samclina Animal Counted PCE/ MNPCE/

(mg/kg) time (hrs) 1 . D . PCE : NCE (PCE+NCE) 1000PCE

1 M01 500 : 500 0.5000 0.5

1M02 491 : 509 0.49~ 0. 5

1 M03 492 : 5C8 0.492 0,0

0.5 %

G1 Methylcellulose 0 P .O

. 24 1 M04 498 : 502 0.498 0.0

1500 1 M05 506 494 0.506 0.5

1 M06 501 : 499 0.501 0.0

Mean 0.498 0.3

S .F) 0.006 0.3

2M07 496 504 0 .496 1 .0

2MC8 492 508 0 .492 1 .0

2MC9 503 497 0 .503 1 . 0

G2 7500 P.O

. 24 2M10 504 496 0.504 0.0

2M11 498 • 502 0 .498 1 .0

2M12 501 : 499 0.501 1 .0

Mean 0.499 0.8

S,D 0.005 0.4

3M' 3 489 : 511 0 .489 1 .0

3M14 500 : 500 0.500 0.0

3M15 495 505 0 .495 1 . 5

G3 1000 P.O

. 24 3M16 492 508 0.492 1 .0

3M17 497503 0 .497 1 .0

3M18 494 506 0.494 0.0

Mean 0.495 0.8

S .D 0.004 0.6

4M19 508 : 492 0.508 1 .5

4M20 504496 0 .504 0.5

4M21 501 : 499 0.501 1 . 0

G4 72000 P.O

. 24 4M22 490510 0.490 1 .5

4M23 504 : 496 0.504 1 .5

--~ 4N24 497503 0 .497 1 . 0

Mean 0.501 1 .2

S .D 0.006 0.4

5M25 496 : 504 0.496 79.5

5h126 497 : 503 0.L97 74.5

51%127 502 : 498 0 .502 81 .0

5 M

G5 Mitornycin C 2 1 . P

. 24 5M28 495 ~ 505 0 .495 90.0

5M29 501 499 0 .501 85.0

5M30 502 498 0.502 77,0

Mean 0.499 81 .2

S .D 0,003 5 .6

MNPCE Micronucleated polychromatic erythrocyt e

PCE : Polychromatic erythrocyt e

NCE : Normochromatic erythrocyte .js i~~}14

N : Number of animals examined
p. 14

BT Study Number: B04109

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Appendix 3 . Result of prelirnirary test(N=3 )

Test item Dose Route Sampling Animal ID MNPCE/ MNPCE/

(mg /kg) time (hrs) 2000PCE 1000PCE

BM01 3.0 1.5

BM02 2 .0 1,0

P .O . 16 BM03 2.0 1.0

Mean 2.3 1.2

_ S .D . 0.6 0. 3

BM04 3.0 1.5

BM05 3.0 1.5

P .O. 24 BM06 2.0 1. 0

Mean 2.7 1.3

2000 -

S .D . 0.6 0.3

BM07 2.0 1.0

BM08 1 .0 0. 5

P .O. 48 BM09 2.0 1.0

Mean 1 .7 0.8

S .D . 0.6 0.3

BM10 2.0 1.0

BM11 3.0 1. 5

P .O . 72 BM12 3.0 1.5

Mean 2.7 1.3

S .D . 0.6 0.3

N : Number of animals examined

MNPCE Micronucleated polychromatic erythrocyte

PCE : Polychromatic erythrocyte

00t1415
p. 15

BT Study Number: B04109

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Appendix 4 . Certificate of analysi s

CERTIFICATE OF ANALYSIS

1 . TEST MATERIAL IDENTIFICATION

(1) TEST MATERIAL LOT No .

g : (2) QUANTITY ~ l00

(3) PRODUCER

ADDRESS • ) an

Tel No.

(4) CHEMICAL NAME(CAS No . if available)

E ~

(5) PURITY ~ About 100 %

(6) APPEARANCE ~ Orange so lid

2 . SOLUBILIT Y

(1) INSOLUBLE ~ Water

(2) SOLUBLE ~ DIviSO, Acetone

3. Storage temperature : Below 30degC

4 . Stability ~ Stable

We hereby certify that the data stated here above are true and correct.

18 Apr 2004

Signature

~

71. n AT

0 {.~~ 416
p. 16

~ - - ~

September 21, 2004

Document Control Officer - f'any Sanirized

Office of Pollution Prevention and Toxic Substances, 740 7

U.S. EPA

Ariel Rios Bldg.

1201 Constitution Ave . NW

Washington, DC 20460

Re: Premanufacture Notices P 04-346, -347 : Additional Toxicity

Report

Dear Sir or Madam:

On behalf of [

] is submitting an additional toxicity study, In Vivo

Micronucleus Test in Mice, for P 04-346, -347 . Accordingly, amended PMN

pages 1 and 12 are included . The PMN review period for these new substances

has been suspended so that a 5(e) consent order can be developed .

This submission does contain confidential business information (CBI) .

Confidential and sanitized copies of the study are included .

If there are any questions regarding this SubmlSS1o11, please do not

hesitate to contact me at [ ].

r_

Sincerely, c~

[ ] _

~ Attachments c7

c. .~

ILIJHll LIll 0 ijU 0 0 5 71 9 1 S

3~
p. 1 7

Form Approved . O .M .B. No . 2070-0012 . Approval Expires 10-31-96 .

U.S. ENVIRONMENTAL PROTECTION AGENCY AGENCY USE ONLY

Dare of receipt

PREMANUFACTURE

\W NOTICE EPA

FOR NEW CHEMICAL SUBSTANCES i

When %iiiiiW- DOCUMENT CONTROL OFFICE R

completed OFFICE OF POLLUTION PREVENTION -' )17?(1~rj V '~'~I~~~

send this AND TOXIC SUBSTANCES, 740 7

o to U.S. E.P .A. 401 M STREET, S W

WASHINGTON, D.C. 20460

Enter the total number of pages 416 Document connol nt.mber EPA case number

in the Premanufacture Notice

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have actual data .

• Before you complete this form, you should read the "Instructions Manual for Premanufacture Notification" (the Instructions Manual is available from the Toxic

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your user fee ID number must also appear on your corresponding fee remittance, w hich is sent to EPA, HQ Accounting Operations Branch (PM-226), P 0 . 360399M.

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If there are several manufacture, processing, or use operations to 'De described in Part It,

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Attach additional sheets if there is not enough space to answer a question fully . Label E wirenn:ental face data ® Yes Other data Z Yes

each continuation sheet with the corresponding section heading. In Part III, list thes e

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You may include any information that you want EPA to consider in evaluating the new A physical and chemical propecies worksheet is located on the last page of this fomt

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that routinely accompany the development of consent orders or Significant New Use

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instructions on claiming information as confidential, read the Instructions Manual . Ye , ~

® 4 of chemicals 2

Mark (x) ifany infonnation in this notice is claimed as confidential . (E'renonce Cotnn•,unica:iou r required, enter # on page 3 )

E?A FORM 7710-25 (Rev . 5-95) Replaces previous editions of EPA Form 7710- 2 5 .
p. 18

`--.

^~ .r .. . .

. r.. . .

June 15, 2004

Document Control Officer

Office of Pollution Prevention and Toxic Substances, 7407

U.S . EPA

Ariel Rios Bldg.

1201 Constitution Ave. NW

Washington, DC 20460

Re : Premanufacture Notices P 04-346, -347 Regulatory Option

Choice

Dear Sir or Madam:

On behalf of [

] is submitting the "SELECTION OF

REGULATORY OPTION" form related to the non-negotiated section 5(e)

consent order for P 04-346, -347 .

This submission does contain confidential business information (CBI) . A

confidential and a sanitized copy of the cover letter and form are included .

If there are any questions regarding this submission, please do not

hesitate to contact me at [ ].

Sincerely,

~

[ ] - . . .

Attachments `

.F-

~

~,o~pany ianlt! ~~~~

111~~ Ilifi 1111~ H11 ~ 1111~ 11111 1E1 ~ 1~ 1 1

5 0 0 4 0 0 0 4 0 4 0/ S

,Q-j►t~l,p.
P. 19

SELECTION OF REGULATORY OPTION

FOR PMN # P-04-346/347

I have reviewed the Agency's letter dated which outlines the

regulatory options for the above-referenced PMN, and I select the following option:

Option 1 - Non-negotiated section 5(e) Consent Order

(60-day suspension recommended)

❑ Option 2 - Negotiated section 5(e) Consent Order

(90-day suspension reconunended)

❑ Option 3 - Upfront submission ofspecified data before commencement of manufacture

(suspension as appropriate)

❑ Option 4 - Upfront submission ofother information before commencement of manufacture

(suspension as appropriate)

❑ Option 5- Withdrawal of PMN per 40 CFR 720.75(c)

(no suspension necessary)

To provide time for implementation of the selected option, I request, pursuant to 40 CFR

720 .75(b), a suspension of the PMN review period for 60 days or until the following date :

_,.

Date

D6/~~/°~ I _

TOTAL P .08
i5 .-1 FPri~ 17/i2

~ March 5, 2004

Document Control Office r

Office of Pollution Prevention and Toxic Substances, 7407

U.S. EPA

Ariel Rios Bldg.

1201. Constitution Ave. NW

Washington, DC 20460

Re: Premanufacture NoticeTS-04ATZ.ti1 - P 04-346, -347 Corrections

Dear Sir or Madam:

On behalf of [

] is submitting corrected PN'[N pages 5 and 5B for

Prcmanufacture Notice TS-04A~N1 - P 04-3,46, -347 .

In the original submission, EPA noticed inconsistencies in the polymer

molecular weight data found on pages 5 and 5B compared to polymer molecular

weight data found in the attachments . has revie,,ved the discrepancies and

now reports that one grade of the new polymer was used for toxicity testing while

molecular weight data from another o ace was placed in the original PMN form.

To date, [ ] has developed three different gradcs of the polymer, which, it '

intends to offer for commercial purposes: r'-

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The corrected PMN pages 5 and 5B now contain the lowest average molecular =- -

weight information for the new polymer while the original pages did not . The

GPC data found on PMN page 21 is associated with polymer grade (1)

. This PMN correction does contain confidential business information (CBT) .

The confidential PMN corrections and two copies are enclosed for EPA review as

well as a sanitized copy .

If there are any questions regarding this submission, please do not hesitate

to contact me at [ ).

Sincerely,

[ ]

Attachments

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