Document KR555nnjXwZE9pawJ5wn3d2Dr
M I M - , 33 7
489
Mn6-307
CHROMOSOMAL ABERRATION TEST RESULTS USING MAMMALIAN CULTURE CELLS
1. General information Nomenclature of novel chemical substance (according to IUPAC nomenclature)_______ Other name Structural formula and empirical formula (outline of preparation method when unknown)
Purity of novel chemical substance used in the test
/
|L o t No. of novel chemical 1 substance used in test
Hr
Name and concentration of impurities CAS No. Molecular weight
n g g j tm
Uncertain 0.4% Vapor pressure Distribution coefficeint
-
-
Melting point Boiling point
Appearance at room
Brown viscous
-
temperature
solid
Stability
Unknown
Solubility in solvents, etc.
Solvent
Solubility
Stability in solvents
Water
<50 mg/mL (measured on site.)
DMSO
<50 mg/mL (measured on site)
Acetone
-
--
Other (ethanol)
Soluble (solubility unknown)
-
[Note]
Hydrolysis property: unknown
* The 50-mg/mL solution was confirmed to be free of discoloration, heat emission, etc., up to 2
h after preparation (confirmed on site at Hita Works)
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2. Cell type and culture conditions
Cell name
CHL/IU
Species Culture solution Serum type and amount added
Cell cycle
No. of generations
No. of chromosomes
(mode) Note:
Chinese hamster Eagle MEM
Newborn calf serum (NBCS), 10% About 15 h
<20 after acquisition
25
Acquisition
Acquisition date Producer
Producer (Lot No.)
Freeze conditions
Container
Incubation Temperature
conditions
co2
concentration
Human Science Shinko Foundation, Research Resources
Bank April 17, 2002 Nippon Seiyaku K.K. Miko Junyaku K.K.
(27020859) -196C
Plastic dish of 90 mm in diameter 37 0.5C
5%
3. S9 mix (1) S9 acquisition, etc.
Self-made or acquisition
Production date Lot No. for acquisition
Storage temperature
1. Self-made Acquisition (Oriental Kobo Kogyo K.K.) May 9, 2003 03050902
-80C
(2) S9 preparation Anima used
Species-origin Rat-SD Sex male Age 7 weeks
Body weight 233.5 8.4 g
Derivative material
Name
PB and 5,6-PF
Dosage
Abdominal cavity
Dose period and dosage (g/kg-body weight)
PB 30 mg/kg one time PB 60 mg/kg three times 5,6-PF 80 mg/kg one time
(3) S9 mix composition Component Amount in 1 mL of S9 S9 0.3 mL
MgCl2
5 pmol
KC1 33 pmol
Glucose-6phosphoric acid
5 pmol
Component NADP
Na phosphate buffer HEPES (pH 7.2)
Others (-)
Amount in 1 mL of S9 4 pmol 4 pmol
-
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(4) S9 mix treatment conditions
Plate method 2. Flotation cell method 3. Other (
)
S9 (final concentration)
5%
S9 protein (final concentration)
1.17* mg/mL
Treatment time
6h
Recovery time
18 h
Time
* S9 Assay Data (Oriental Kobo Kogyo K.K.)
4. Preparation of test substance solution
Solvent used
Reasons for solvent selection
Name
Producer
Lot No. Grade
Purity (%)
Distilled water
Otsuka Seiyaku K.K.
K2J77
Injectable water
-
The test substance was not dissolved to [sic] 50 mg/mL in clistilled water or
500 mg/mL in DMSO and acetone, while 5 0 mg/mL in cistilled water
showed a good suspension state; furthermore, there was no leat emission or
discoloration at room temperature up to 2 h after preparatic n, thus distilled
water was chosen as the solvent.
Test substance solution
Dissolution C^Suspension^> Other (
)
Method for suspension, etc.,
when the test substance is not
soluble Storage time and temperature of the
solution after preparation
Stirring alone gave a good suspension, thus the Labomixer was used for making the suspension
Within 2 h, room temperature
Purity conversion
Yes C n < Q
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/ 'n 5. Short-term treatment test
(1) Conditions for cell growth inhibition test
Incubator
Test duration Shape Size
Culture solutiona)
Without metabolism activation
6/25/03 to 6/26/03 Round plastic dish Diameter: 60 mm
3 mL/dish
With metabolism activation
6/25/03 to 6/26/03 Round plastic dish Diameter: 60 mm
3 mL/dish
No. of incubators per dose
2
2
Cells
Treatment conditions
No. of inoculated cells
Incubation duration
Amount of test substance solution added b)
Amount of S9 mix added S9 final concentration
S9 protein final concentration
1.5 x 104/mL 2 days
0.3 mL/dish
-- -
1.5 x 104/mL 2 days
0.3 mL/dish
0.5 mL/dish 5%
1.17 mg/mL
Treatment time 6 h 6 h
Recovery time
18 h 18 h
Cell growth inhibition measurement
Electric cell counter (Microcell Counter CDA-500) was used for counting the number of cells
Notes
a) Liquid quantity at treatment time. Recovery period [sic; level] after treatment: 5 mL/dish
b) Composition of medium used in the treatment of the test substance: Without metabolism activation:
Medium 2.7 mL (= NBCS 0.3 mL + 2-fold concentration MEM (x 2 MEM) 1.35 mL +
distilled water 1.05 mL) + test substance solution 0.3 mL
With metabolism activation:
Medium 2.2 mL (= NBCS 0.25 mL + x2 MEM 1.125 mL + distilled water 0.825 mL) -f
S9 mix 0.5 mL + test substance solution 0.3 mL
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(2) Cell growth and aberration cell appearance frequency
Without metabolism activation (6-18)
With metabolism activation (6-18)
Dose (pg/mL)
0 19.5 39.1 78.1 156 313 625 1250 2500t
Cell g r o w th "'
(%)
100 93.3 84.7 84.2 70.9 66.9 59.1 53.0 64.2
Incidence of split cellsb)
abundant abundant abundant abundant abundant abundant abundant abundant abundant
Aberration cell appearance frequency"' Structural Numerical aberration aberration
02 n.o. n.o. n.o. n.o. n.o. n.o. n.o. n.o. n.o. n.o.
00 60
22
Dose (pg/mL)
0 19.5 39.1 78.1 156 313 625 1250 2500t
Cell g ro w th "'
(%)
100 101.9 90.5 92.3 86.4 87.4 79.1 75.3 72.6
Incidence of split cells6'
abundant abundant abundant abundant abundant abundant abundant abundant abundant
Aberration cell appearance frequency"'
Structural aberration
Numerical aberration
20
n.o. n.o.
n.o. n.o.
n.o. n.o.
n.o. n.o.
n.o. n.o.
00
42
40
5000t 59.7
abundant
a) Average value of 2 sheets
b) abundant: sufficient split cells
a few: few split cells
c) 50 cells were observed
n.o.: not observed under microscope
6
0 5000t 66.0
rare: very few split cells none: no split cells at all
abundant
4
0
f: Test substance precipitation occurred at the beginning and end of the treatment. Note) Upper limit of dosage was set at 5000 pg/mL
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(3) Chromosome aberration test conditions
Without metabolism With metabolism
activation
activation
Test duration
7/2/03 to 7/3/03
7/2/03 to 7/3/03
g
Shape
Round plastic dish Round plastic dish
3 Size Diameter: 60 mm Diameter: 60 mm
3O Culture solutiona)
3 mL/dish
3 mL/dish
*3 No. of incubators per dose
2
2
Cells
No. of inoculated cells Incubation duration
1.5 x 104/mL 2 days
1.5 x 104/mL 2 days
a g .2 cd T3 2S Ho
Amount of test substance solution addedb) Amount of S9 mix added S9 final concentration
S9 protein final concentration
Treatment time
0.3 mL/dish --
-
6h
0.3 mL/dish 0.5 mL/dish
5% 1.17 mg/mL
6h
Recovery time
18 h 18 h
Notes
a) Liquid quantity at treatment time. Recovery period [sic] after treatment: 5 mL/dish
b) Composition of medium used in the treatment of the test substance:
Without metabolism activation:
Medium 2.7 mL (= NBCS 0.3 mL + x2 MEM 1.35 mL + distilled water 1.05 mL) +
test substance solution 0.3 mL
With metabolism activation:
Medium 2.2 mL (= NBCS 0.25 mL + x2 MEM 1.125 mL + distilled water 0.825 mL) +
S9 mix 0.5 mL + test substance solution 0.3 mL
Cell growth was calculated from the number of cells counted by electric cell counter (Microcell
Counter CDA-500)
(4) Chromosome aberration test results (Table 1)
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6. Continuous treatment test
(1) Cell growth inhibition test conditions
Test duration
Shape
Incubator
Size Culture solution
6/25/03 to 6/26/03 Round plastic dish Diameter: 60 mm
5 mL/dish
No. of incubators per dose
2
Cells
No. of inoculated cells Incubation duration
2 days
Treatment conditions
Amount of test substance solution addeda) Treatment time Recovery time
0.5 mL/dish 24 h Oh
Cell growth inhibition measurement
Number of cells counted by electric cell counter (Microcell Counter CDA-500)
Note a) Composition of medium used in treatment of test substance
Medium 4.5 mL (= NBCS 0.5 mL + x2 MEM 2.25 mL + distilled water 1.75 mL) + test substance solution 0.5 mL
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(2) Cell growth and aberration cell appearance frequency
Without metabolism activation (24-0)
Dose (pg/mL)
Cell g ro w th a)
Relative split index b)
Incidence of split
(%) (%) cellsc)
0 100
100 abundant
Aberration cell appearance frequency d) (%)
Structural aberration
Numerical aberration
00
19.5 39.1 78.1 156 313 625 1250
95.2 98.8 91.5 83.2 61.7 33.5 24.0
93.9 abundant 65.3 abundant 20.4 a few n.o. rare n.o. none n.o. none n.o. none
n.o. 0 0 n.o. n.o. n.o. n.o.
n.o. 0 0
n.o. n.o. n.o. n.o.
2500t
16.5
n.o.
none
n.o.
n.o.
5000r
11.7
n.o.
none
n.o.
n.o.
a) Average value of 2 sheets b) Calculated by split cells in 500 cells c) abundant: sufficient split cells
a few: few split cells
rare: very few split cells none: no split cells at all
d) 50 cells were observed
n.o.: not observed under microscope
f : Test substance precipitation occurred at the beginning and end of the treatment.
Note) Upper limit of dosage was set at 5000 pg/mL
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(3) Chromosome aberration test conditions
Test duration
7/2/03 to 7/3/03
Incubator
Shape Size Culture solution
Round plastic dish Diameter: 60 mm
5 mL/dish
No. of incubators per dose
2
Cells
No. of inoculated cells Incubation duration
1.5 x 104/mL 2 days
Treatment conditions
Amount of test substance solution addeda) Treatment time Recovery time
0.5 mL/dish 24 h Oh
Note
a) Composition of medium used in treatment of test substance
Medium 4.5 mL (= NBCS 0.5 mL + x2 MEM 2.25 mL + distilled water 1.75 mL) +
test substance solution 0.5 mL
Number of cells counted by electric cell counter (Microcell Counter CDA-500) for
cell growth
(4) Chromosome aberration test results (Table 2)
(5) Split index in chromosome aberration test (Table 3)
9
7. Result evaluation and notes
(1) Result evaluation__ ___ Evaluation (surrounded by a circle)
Positive
(Negative^)
Reasons for evaluation The evaluation is given because of no chromosomal aberration increase in both the short-term treatment and continuous treatment
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(2) Notes 1. Reasons for setting dosage of test substance Cell growth inhibition test results
Treatment method
Short-term treatment
Continuous treatment
- S9 mix + S9 mix
24-0 h
IC5o value >5,000 pg/mL >5,000 ug/mL About 440 pg/mL
Maximum dosage used for observation of needed split image and [cell growth] 5,000 pg/mL [59.7%]
5,000 pg/mL [66.0%]
78.1 pg/mL [91.5%]
In short-term treatment, the maximum dosage for observing mid-term split images
needed for analysis of chromosomal aberrations had an upper limit of 5000 pg/mL in the
presence or absence of the S9 mix. Both in the presence and absence of the S9 mix, with a
maximum dosage at 5000 pg/mL, and with the appearance of light cell toxicity, 1580 and 500
pg/mL diluted at a nominal ratio [sic] of VlO were set.
In the continuous treatment, the maximum dosage for the observation of the mid-term
split image needed for analysis of chromosomal aberrations was 78.1 pg/mL. At 78.1 pg/mL,
cell growth was 91.5%, and the relative split index was inhibited to 20.4% of the negative
control, thus a distinct cell toxicity was judged to occur. Thus, the concentration for inhibiting
50% of split cells in the cell growth inhibition test was about 52 pg/mL; with a maximum dosage
of 78.1 pg/mL, 39.1 and 19.5 pg/mL diluted by a nominal ratio of 2 were set.
2. Toxicity evaluation in continuous treatment
At 78.1 pg/mL set as the maximum dosage used in the continuous treatment, the cell
growth in the chromosome aberration test is 86.9%; cell growth inhibition exceeding 50% is not
observed, while a relative split index compared with the negative control is decreased to 38.3%;
thus, it is judged that a distinct cell toxicity needed for evaluating chromosomal aberrations
occurred.
3. Chromosome aberration evaluation standard
A positive judgment is given when the appearance frequency of cells having structural
aberrations and numerical* aberrations increased more than 10% with a dependence on the
dosage or when an increase exceeding 5% is regenerated in the chromosome aberration test and
confirmation test; all others are judged as negative.
4. Figures
Figure 1: Cell growth inhibition test results of short-term treatment u s i n g H f J 0 J f 0 |^ . . J k
Figure 2: Chromosome aberration test results of short-term treatment u s i n f i H H H f l H f l |f l [ J [
Figure 3: Cell growth inhibition test results of continuous treatment u s i n | M j H f ^ ^ P ^ '^
Figure 4: Chromosome aberration test results of continuous treatment usip
[Not certain if "numerical" in this case indicates the "number" of aberrations.]
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8. Others Test facilities
Principal tester Test duration
Test No.
Name
Address
Department and Name
Experience
Hita Works; Kagaku Busshitsu Heikakenkjukiku 3-822 Ishii, Hita, Oita Tel 0973 (24)7211 Fax 0973 (23) 9800
Test Department 3
Yoshikazu Anjimi
17 years 6/23/03 to 11/13/03
K06-1022
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Os L
Table 1: Chromosome aberration test results (short-term treatment)
-d Gap Numberofcellsof[with]chromosomenumerical aberrations
Number ofcells with chromosome structural aberrations (appearance frequency %') appearance
(appearance frequency%)
Treatment^ time
S9mix
Number of Dosage cells (na/mL) observer!
ChromosomeChromosomeChromosome Chromosome fragment fragment cleavage exchange cleavage exchange
Other
Total numberof requency Cellgrowth Numberof
aberrationceils appearance
Ils
reauencv%) (%) ihserverl
Multiple
Other Total numberof aberration cells
negativecontrol 100 0 0 1 0 0
1
0
100 1
0
i
6-18
(D.W.) 100 2 0 0 0 0
2
l 100 100 2 0 2
0 200 2( 1.0) 0( 0.0) H 0.5) 0( 0.0) 0( 0.0) 3( 1.5) 1( 0.5)
200 3( 1.5) 0( 0.0) 3 ( 1-5)
100 1
0
0
0
0
1
0 79.9 100 0 0 0
6-18 - 500 100 1 1 0 0 0
2
0
76.5 too
1
0
1
200 2( 1.0) K 0.5) 0( 0.0) 0{ 0.0) 0( 0.0) 3 ( 1.5) 0( 0.0) ( 78.2) 200 H 0.5) 0( 0.0) K 0.5)
100 0 0 1 0 0
1
1
72.6 too
0
0
0
6-18 - 1.580 100 3 0 0 0 0
3
0 75.0 100 3 0
3
200 3( 1.5) 0( 0.0) l ( 0.5) 0( 0.0) 0( 0.0) 4 ( 2.0) 1( 0.5) ( 73.8) 200 3 ( 1.5) 0( 0.0) 3 ( 1.5)
100 1 0 0 0 0
1
1 77.8 100 2 0
2
6-18
- 5.0001 100
1
0
0
0
0
r
1 68.9 100 0 0
0
200 positivecontrol 100
2( 1.0) 0( 0.0) 0( 0.0) 0( 0.0) 0 ( 0.0) 2 ( 1.0) 31 40 1 0 0 57
2 ( 1.0) ( 73.4) 3
200 100
2 ( 1.0) 0( 0.0) 2 ( 1.0)
10
1
6-18 - I (MMC) 100 19
37
3
0
0
52
1
100 0 0 0
0.1 200 50 ( 25.0) 77 ( 38.5) 4( 2.0) 0( 0.0) 0 ( 0.0) 109 ( 54.5) 4 ( 2.0)
200 1( 0.5) 0( 0.0) H 0.5)
negativecontrol 100
1
1
0
0
0
6- 18 + (D.W.) 100 0 0 0 0 0
2 0
1 100 0 0 . 100 100 l
0 0
0 1
0 200
K 0.5) K 0.5) 0( 0.0) 0{ 0.0) 0( 0.0) 2 ( 1.0) U 0.5)
200 K 0.5) 0( 0.0) H 0.5)
100 0 0 0 0 0
0
1 90.4 100 0 0
0
6-18
500 100 0 0 0 0 0
0
0'
92.8 100
1
0
1
200 0( 0.0) 0( 0.0) 0{ 0.0) 0{ 0.0) 0( 0.0) 0( 0.0) If 0.5) (91.6) 200 l ( 0.5) 0( 0.0) 1( 0.5)
100 0 0 1 0 0
1
0
91.8 100
l
0
1
6-18 + 1,580 100 0 0 0 0 0
0
0 90.4 100 2 0
2
200 0( 0.0) 0( 0.0) 1( 0.5) 0( 0.0) 0( 0.0) 1( 0.5) 0( 0.0) ( 91.1) 200 3( 1.5) 0 ( 0.0) 3 { 1.5)
too 1 0 0 0 0
1
0 71.7 100 0 0 0
6-18 + 5.0001 . 100 0 1 0 0 0
1
0 79.2 100 0 0
0
200 positivecontro! 100
1( 0.5) K 0.5) 0( 0.0) 0( 0.0) 0( 0.0) 2 ( 1.0) 32 42 3 0 0 54
0( 0.0) ( 75.5) 1
200 100
0( 0.0) 0< 0.0) 0( 0.0)
10
1
6-18 + (CPA) 100 39
64
0
0
0
75
1
100 0 0 0
6 200 71 ( 35.5) 106 ( 53.0) 3( 1.5) 0( 0.0) 0( 0.0) 129 ( 64.5) 2 { 1.0)
200 --5) 0( 0.0) __ I I - M .-
The treatment duration is treatment time - recovery time. Data for aberration cell numbers in plates of each group are given in the first and second rows, with their sum in the third row. The numerical value of cell growth in plates of each test substance group are given in the first and second rows, with their sum in the third row. D.W.: distilled water MMC: mitomycin C CPA: dichlorophosphamide hydrate
f : Test substance precipitation occurred at the beginning and end of the treatment.
to
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Table 2: Chromosome aberration test results (continuous treatment) Test substance n a m e l l M H H H H B |
Number of cells with chromosome structural aberrations;(appearance frequency % )
Gap appearance
Numberofcellsof[with]chromosomenumerical aberrations (appearance frequency% )
Treatment v time
Numberof Chromosome Chromosome Chromosome Chromosorhe
Dosage cells
fragment ragment cleavage exchange
observed cleavaae exchange
Other
Totalnumberof frequency CellgrowthNumberof
aberrationcells (appearance
cells
frequency%) (%) observed
Multiple
Other rotai numberof aberrationcells
negativecontrol 100
0
10
0
0
l
1
100 1
0
1
24-0
(D -W .)
' 100
1
0
0
0
0
1
0 100 100 1
0
1
o
r
o
IS 3
0 200 I t 0.5) K 0.5) 0( 0.0) 0( 0.0) 0( 0.0) 2 ( .1.0) K 0.)
200 2( 1.0)
2( 1.0)
100 2 0 0 0 0
2
0
91.9 100
0
0
0
24-0 19.5 100 0 0 0 0 0
0
0
90.5 100
1
0
1
200 2{ 1.0) 0( 0.0) Q( 0.0) 0( 0.0) 0< 0.0) 2( 1.0) Of 0.0) ( 91.2) 200 K 0.5)
1 ( 0.5)
100 2 0 0 0 0
2
0
83.8 100
1
0
1
24-0 39.1 100 0 .0 0 0 0
0
0
78.8 to o
0
0
0
200 2< 1.0) 0( 0.0) 0{ 0.0) 0( 0.0) 0( 0.0) 2( 1.0) 0( 0.0) ( 81.3) 200 1( 0.5) 0 ( 0.0) K 0.5)
100 0 0 0 0 .0
0
0
76.4 100
2
0
2
24-0 78.1 100 0 0 0 0 0
0
0
97.4 100
1
0
1
200 positivecontrol 100
Of 0.0) 0( 0.0) 0{ 0.0) 0( 0.0) 0( 0.0) 0( 0.0) 28 41 2 0 0 56
0 ( 0.0) ( 86.9) 2
200 100
3{ 1.5) 0 ( 0.0) 3 { 1.5)
10
1
24-0 1 (MMC) 100 16
S3
3
0 0 60
0
100 0
0
0
I 0.05 200 44 ( 22.0) 94 ( 47.0)
0( 0.0) 0( 0.0) 116 ( 58.0) u 03
200 ...... L L . J 1 0( 0.0) I t 0.5)
The treatment duration is treatment time - recovery time. Data for aberration cell numbers in plates of each group are given in the first and second rows, with their sum in the third row. The numerical value of cell growth in plates of each test substance group are given in the first and second rows, with their sum in the third row. D.W.: distilled water MMC: mitomycin C
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Table 3: Split index in chromosome aberration test (continuous treatment)
Treatment time (h) S9 mix Dosage (pg/mL) Relative split indexa) (%)
Negative control
(distilled water)
100
24-0 -
0 19.5
101.8
39.1 80.0
78.1 38.3
Relative split index is calculated based on 100% as the split index of the negative control,
a) Calculated with the observation of 1000 cells per dose.
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Cell growth (%) 100 -
15
50-
0 -1-------------------:----------- 1------------------------------ 1---------:--------------------- 1
10
100
1,000
10,000
Dose (gg/mL)
- S9 mix
Cell growth (%)
Figure 1: Cell growth inhibition test results of short-term treatment usin
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Appearance frequency of chromosome aberration cells (%)
30-
O numerical aberration structural aberration
20 H
ioH
1580
Dose (pg/mL) - S9 mix
Appearance frequency of chromosome aberration cells (%)
16
--l
5000
Figure 2: Chromosome aberration test results of short-term treatment using
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Cell growth (%)
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Figure 3: Cell growth inhibition test results of continuous treatment usin
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Appearance frequency of chromosome aberration cells (%)
30-|
O numerical aberration structural aberration
20-
10
18
0 19.5 39.1
Dose (pg/mL) 24 h treatment
Figure 4: Chromosome aberration test results of continuous treatment using
78.1
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Responsibility Chart
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Title: Chromosomal aberration test o'
ising mammalian cultured cells
Name Principal tester Yoshikazu Aiimi Tester Junko Kawaguchi Shinya Wakabayashi
Responsibility Test planning, management of overall test, specimen observation, results analysis, evaluation, report preparation Preparation and treatment of test substance, specimen observation Specimen observation
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RELIABILITY WARRANTY
Kagakubusshitsu Heikakenkyukiko Hita Works
Test Requester: Dupont K.K. Test Title: Chromosomal aberration test o1 Test Code: K06-I022
ising mammalian cultured cells
This test has been audited or inspected by the QA Division of Hita Works, Kagakubusshitsu Heikakenkyukiko. Supervision or inspection dates and dates reported to the principal tester and management are given below.
Auditing or inspection items
Test plan documented Test substance preparation and test start Amendment of test plan document Recording and report draft Amendment of test plan document (No. 2) Final report draft review Amendment of test plan document (No. 3) Final report draft review Final report
Auditing or inspection date
6/25/2003 7/2/2003 7/2/2003 10/21/2003 10/24/2003 10/29/2003 10/30/2003 10/30/2003 11/13/2003
Auditing or inspection results
report date 6/26/2003 7/2/2003 7/3/2003 10/21/2003 10/27/2003 10/29/2003 10/30/2003 10/30/2003 11/13/2003
This report accurately describes the testing method and procedure and the reported results accurately reflect the raw data of the tests.
November 13,2003 Keiji Shiraishi
Reliability Warranty Officer
Language Services Unit Phoenix Translations January 14, 2004
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