Document 1059756

The Honorable Lee M .
Administrator
Thomas
"x
U .S . Environmental Protection Agency
1200 West Tower
401 M Street, SW
Washington, DC
20460
Dear Mr .
-re d/ Cca
Thomas :
In accordance with the Chemical Manufacturers Association's
policy of making publicly available all final reports developed
in research projects that it administers, the following report is
enclosed :
°°Hydroquinonem
A Developmental Toxicity Study in Rats"
-:-
To preserve the investigators` prerogative to publish these
data in a suitable scientific journal, we request that you
attempt to confine distribution of these reports to your agency
only .
Sincerely yours,
0
"If
Enclosure
Formerly Manufacturing Chemists Association-Serving the Chemical Industry Since 1872 .
2501 M Street . NW " Washington, DC 20037 9 Telephone 202i887-t260 " Telex 89617 (CPAA WSH)
I88528F
TX-85-50
Walter Jm Krasavage, .
.5
M
Toxicological Sciences Section
Health and Environment Laboratories
Eastman Kodak Company
Rochester, N.Y .
14650
September 25, 1985
*Sponsored by the Hydr oquinoneBQuin one Program Panel under the auspices
of the Chemical Manufacturers Association, CMA Contract HYQ-2 .0-Kodak .
Page
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1
00004
In conclusion, doses as high as 300 mg/kg hydroquinone did not
produce teratogenic effects, other embryotoxicity, or fetotox3.city in the
rat .
0 C)0
188528F
TX-85-SO
i3.
33ydroquinoase :
Developmental Toxicity Study 3.a Rats
conduct of this study:
The following key personnel were involved in. the
:
Others are identified by signatures on the raw data sheets
Z'eratoYogist-Study Director
Study Technician
Walter .T . ICrasavage, M05,
Lisa G . Bernard, AoA .S 6 '
1.
John W . Moslaer, B .S .
Milan S . Vlaovic, ISoV .Mo, F'h .Do Richard A. Schumacher, MoS .
Mm Susan .Tames, A .A .S .
.
Ee V. Jeszenka, V .MmDe9 ~~S
Robert Emnnons, B .So
Company, Rochester, 31I'
~~,,~.dy T--chniriapPathologist
Analytical Chemist
Quality Assurance Coordinator
Laboratory Animal. Care
Animal Clinical Chemistry
1.4650 under contract for the &3ydsoquinone/Quinone
Washington . D .C .
Program Panel of the Chemical Manufacturers Association,
archives of the HAEI. .
All raw data relating to the study are in the
The
data and accurately
data presented in this report summarize these
perftn~nt to the
reflects the results of this study . Individual data
are included in the appendiceso
summary tables presented in this report
..~'"
Study
.
irect
Date
188528F
TX-85-50
,
H,droQuinone :
A Developmental Toxicity Study in Rats
Introduction
Environment Laboratories (L),
Eastman Kodak Company was retained hp
the Panel to develop a protocol (see Appendix 1) to determine the
potential developmental toxicity of hydroquinoneo
conducted by .
A. probe study was
in order to select appropriate dose levels for the
study reported here .
A report of the results of this probe study,
4
Cl
0 1-..
6007
.
'
-z-:
1$8528F
T7C-85-50
Materials and Methods
j Fiydresquinone was administered to the test animals by gavage as a 5%
i_soyution in distilled water .
Fresh solutions were made daily and
analyses to verify the concentration of hydroquiaone were done three
times a week (Appendix 11) .
Following are some pertinent physical°-chemfcall properties of hydroquinone :
Structural Formula :
Molecular Formula :
./
C6Ii602
Molecular Weight :
110 .1
Melting Point :
274%
Vapor Pressure :
1.
Form :
white crystalline solid
Solubility :
very soluble in water, acetone and ethanol '
g at ].32°C
188528F
TX-85-50
°3°
Test. Animals
titers in randomly selected animals, but at this time only a few of the
animals exhibited clin-ical signs of SI9Ae
On February 15, 1985, no
females and only a few males exhibited signs of 5DA .
On February ]L9,
1985 all animals appeared clinically normal, therefore, breeding was
begun to obtain the inseminated females needed to begin the study .
No
C) 0 U9
-
1~8528F
TX-85-50
signs of SDA were noted during the remainder of the study" . ~ The extension
of the acclimation period allowed the SDA infection to run its course and
it is our conclusion that the SDA infection did not compromise the
results of this study .
The males and females were mated 1. :1. over a 4-day period. to obtain
1.20 inseminated females .
Copulation was detected by the presence of a
vaginal . plug and the day on which a plug was found was considered day 0
VJ
of gestation .
As the females became inseminated, they were assigned to
tap water, delivered by an automatic watering system, were available ad
30 animals received a volume of distilled water daily an gestation days
6-m15 equivalent to the largest volume given a treated animal .
Individual
.
-5-
188528F
TX-85-50
maternal body weights were recorded on gestation days 0, 6, 9, 12, 16 and
19 and individual feed consumption was measured from days 0-6, 6-9, 9-1 .2,
12-16 and 16-19 of gestation .
All animals were observed for clinical
on weekends during the non-treatment period, cageside observations for
morbidity and mortality were made .
On the 20th day of gestation, the females were anesthetized by C02
inhalation and the abdominal. viscera were exposed by a midline incision
through the ventral body wall .
,j
A1.3. females were fasted overnight prior
classified. as "early" when no placenta or conceptur. was distinguishable,
and as "late" when a placenta containing an embryo in the process of
188528F
TX-85-50
t
were fixed in Bouin°s solution and examined for internal soft tissue
were examined in ~itu for gros~ abnarmalities : at the time of cesarean
section .
The liver and icidne_vs, were weighed for organ/body weight
comparisons and only sections of these organs were collected for
tcistologic examination .
The uteri of apparently nonpregn.ant females were
stained with lOX sodium sulfide and examined for imp3.antations .3
Statistical Analyses
-
Treated groups were compared to the control group at a level of
Good LaboratorX Practices
This study was conducted according to Good Laboratory Practices as
promulgated by the Food and Drug Administration 21.Ck'R, Part 58,
report (page l4) .
Results
period which took. approximately 45-60 minutes .
analytical. results is Dresented in Table I .
A summary of the
The mean concentrations of
hydroquinome in the test solutions used in this study were within ±6%
of the target concentration and the analyses done following the dosing
period indicated that the solutions were stable during the time they were
administered .
() 001 13
188528F
TX-S5-50
-8-
Maternal Observations
Body Weight Response and Feed Consumption
Though not statistically significant, the mean maternal body weight
of the high-dose dams (300 mg/kg) was slightly reduced from the third
treatment day (day 9 of gestation, Table 2) to the end of the study . ,
'k
less than that of the controls .
Feed intake of the 300 mg/kg dams was
slightly but significantly less than the controls during the treatment
period (Table 4) .
Clinical Signs, Gross and IiistoMthology
J
The only treatment related clinical sign noted was the appearance of
brown colored urine during the treatment period on dropping trays of all
hydroquinone-treated dams .
This discoloration was probably due to the
oxidation of free hqciroquiaone which may have been present in the urine .
One dam died immediately following the 6th dose of 1.00 mg/kg
hydroquinone (day 1.7. of gestation) .
Gross pathologic changes included
dark brown discoloration around. thenose .
The lungs were reddish colored
and did not collapse when the thoracic cavity was opened .
These changes
00014
Terminal Body Weights and Organ Weights
Mean absolute liver and kidney weights of the hydroquinone treated
dams were comparable to those of the control animals (Table 5) .
The
relative liver and kidney weights of all hydroquinone treated dams were
slightly greater than the control weights .
Although some of these
increases were statistically significant, the fact that the magnitude of
=the increase was so small, the lack of a dose response and no evidence of
histopathologic changes suggest that these changes are not toxicologiC~)~
cal.ly significant .
When the relative liver and kidney weights ,were
calculated using the corrected body weights (terminal body weight minus
gravid uterus), and analyzed statistically, none of the treated groups
.
were different (p.:SO .05) compared to controls (table not included) .
00014.3
-io-
18aszaF
TX-85-50
Observations at the Time of Cesarian Sections
body weight was significantly (p~}o05) reduced in the 300 mg/kg group
compared to the controls .
.i
When the fetal weight of the males and females
were analyzed separate:y, the female weight was statistically less than
the controls and the male fetal body weight, though slightly less than
the control weight, was not statistically different .
Fetal Examinations
External, internal soft tissue and skeletal. examinations of the
fetuses revealed no treatment-related malformations in any of the
fetuses in the 300 mg/kg group .
rn I (;
0 UU
188528F
TX-85-50
Minor internal soft tissue alterations included dilated renal pelvis
(due to shortened renal papil.lae)s hydronephrosfs (absent renal
papillae), and hydraur,eter .
These changes were seen more frequently in
Skeletal alterations included partial/nonossification of some
ossified in many o£ the fetuses in all groups including the control
group .
A few fetuses had rib variations .
These variations are commonly
seen in 2+D-day old rat: fetuses in developmental toxicity studies 4 and
except for two cases, they did not occur at a significantly higher
'
incidence in the treated groups compared to the control. group .
Partially
ossified lst and 2nd thoracic centra were seen less frequently in the lOQ
mg/kg fetuses than the controls and the incidence of total. vertebral
variations was greater in the 300 mg/kg group t
~-'
in the control group .
However, there was no dose response i8 either of these cases, and since
statistical analyses of individual vertebral variations, as well as
analysis of all skeletal alterations combined, indicated no significant
VWJ
-12-
188528F
TX-85-50
increase in skeletal alterations between the hydroquiaone°°treated and the
control groups, these findings are not considered toxicologically
significant .
Discussion
iiydroquinone exhibited a low order of maternal toxicity resulting in
.
a slight reduction in body weight gain and feed intake in those 'dams
given 300 mg/kg hydroqui.nane .
There were no clinical signs of toxicity
and absolute and relative liver and kidney weights were comparable to the
control. weights .
Gross and histologie appearance of the livers and the
kidneys were normal. .
significantly higher incidence in the treated groups when compared to the
Reproductive 'indices of the dams treated with hydroquinone were
,/
comparable to the controls .
The reduction in the fetal body weight seen
in the 300 mg/kg fetuses was statistically significant only for the
06,1018
00019
-14-
i8ssz8F
'
Z'R-85-50 ,
date
date
C . J47Terhaar, Ph .D ., Supervisor
Toxicological Sciences
~
5-
85 OC T 3 1
date
Thomas S . Ely, M .I3a, Direaor
Occupational Health Laboratory
--U--I 61., Ph .D .
lyl3o
date
Milan s . vlaovic, D .v .M
Pathologist
-°°`
Gary V . Katz, (Ivf .D .
Reviewer
.
~ `- t ~s
date
2
188528F
TX-85-50
-15-
References
8
0602,
O .A . INSPECTION STATEMENT
_
_°
09!23/83
CCF9R 39 .35(E)t7))
STUDY : 93-0155°3
STUDY DIRECTOR : KRASAVAGE,U .J .
ACCESSION NUMBER : ' 900356
'UDY TYPE :
TERATOLOGY
L
i i Uli R , 4ALA SUVIiC
N
--------------- ---------------------------------------------------------------THIS STUDY WAS INSPECTED BY I OR MORE PERSONS OF THE QUALITY ASSURANCE UNIT OF THE HAEL, EASTMAN
KODAK COMPANY, ROCHESTER, N .Y . AND WRITTEN STATUS REPORTS WERE SUBMITTED ON THE FOLLOWING DATES :
IMSPECTIOk
DATES
j
PHASE(S)
INSPECTED
O STATUS REPORT
DATES
--- -----
01/30/05
PROTOCOL SUBMISSION
C2I20/85
VAGINAL SHEARS AND/OR CHECK FOR PLUGS
TEST SYSTEM RANDOMIZATION
TEST SYSTEM WEIGHTS
FEEDER WEIGHTS
A2/20/85
03/04/85
TEST ARTICLE CARRIER MIXTURE DOSING OF TEST SYSTEMS
CONTROL ARTICLE DOSING OF TEST SYSTEM
TEST ARTICLE CARRIER MIXTURE PREPARATION RECORDS REVIEW
SAMPLE/SPECIMEN SENT FOR ANALYSIS
43104/B5
TEST SYSTEM WEIGHTS
FEEDER WEIGHTS
CLINICAL SIGNS A .B .
CLINICAL SIGNS POSTDOSE
83/93/B5
TEST SYSTEM WEIGHTS
03!14/85
BLEEDING .
6R055 PATHOLOGY
CAESAREAN SECTIONS
COUNT IMPLANTATION SITES
COUNT CORPORA LUTEA
03/15/B5
05/0?iBv
PROTOCOL AMENDMENT
GRAVID UTERUS TO NE REMOVED AND UEIGHED
SOFT TISSUE SECTIONING OF FETUSES
SOFT TISSUE EXAMINATION OF FETUSES
BEFORE OPENING
05/02/85
PAGE
?
Q9!23185
G .A . INSPECTION STATEMENT
tCFX 58 .35tBDt ;'i)
STUDY : 93-0155-3
ACCESSION NUMBER :
06/06195
090 :?P8S
46I23/95
D
STUDY DIRECTOR : KRASAVAGE,U.J .
900356
SOFT TISSUE EXAMINATION OF FETUSES
SOFT TISSUE SECTIONING OF FETUSES
SKELETAL EXAMINATION OF FETUSES
DATA RECORDING
STATUS OF FINAL REPORT
PAPER BEING WRITTEN
091i1/85
PROTOCOL AMENDMENT
ADD JUSTIFICATION FOR SELECTION OF TEST SYSTEM
ADD NO CONTAMINANTS THAT NAY C0AFRONISE STUDY
ADD CHOICE OF ROUTE OF ADMINISTRATION
ADD START WILL BE WHEN BREEDING STARTS
ADD FINAL REPORT WILL BE ISSUED WITHIN 9 MONTHS OF START
FINAL REPORT REVIEW
09/12/65
FINAL REPORT REVIEW
09/13!85
FINAL REPORT REVIEW
09d16165
FINAL REPORT REVIEW
09117/B5
FINAL REPORT REVIEW
09Bi8/B5
FINAL REPORT REVIEU
09/11/85
FINAL REPORT REVIEW
O6/OblBS
,
04/t9/85
Hydroquinone - Developmental Toxicity Study in Rats
Summary of Test Solution Analysesa
°X $ydresqu3,nonePrior to
Dosing
After~
Dosing
d
5 .0 ± 0,4C
5 .0 ± 0,2
-
5 .1 ±~0 .3
4 .7¢ 0 .1
5 .0 ± 0m04
5 .0 t 0,1.
4 .8 ± 0o2
4 .9 ± 0o1
500 ± 0 .1
_
00023
Hydroquinone - Developmental Toxicity Study in Rate
Maternal Body Weight
0
215± 11
6
b
215± 16
2I5± 14
216 - 13
249 ± 14
250 ¢ 19
251. ± 17
249 ± 13
9
262 ± 16
263 ± 20
261 ± 18
255 ± 15
12
278 ¢ 19
279 ± 22
277 ± 21
268 ¢ 14
16
305 ± 24
307 ± 26
301 ± 24
293 ± 17
19
341 ± 23
342 ± 31
334 ± 27
330 ± 20
240 ¢ 20
243 ± 20
240 ± 20
231 ± 14
Corrected Body Weight(g)c'
000
Maternal Body Weight Change (g/d
Dose Group (mg/kg)
Mortality/Pregnant Female
0
0/2k
)
30
100
Q/2 9
1/28 a
0125
35 ¢ 7
36± 6
33± ~
300
Gestation Days :
b
0 -6
35 ± 7
6 -9
12 ± 4
13 ± 7
1.1± 3
9- .12
15 ± 9
16 ± 7
15± 5
14f6
2.2m16
27 ± 9
28 ± 8
24± 7
25± 7
16°39
36 ¢ 8
35 ± 9
33± 3
37± 8
55 ± 16
57 ± 11
50 ¢ 9
44 {l1'
6 -1.6
6 ± 6c
Maternal Feed Consumption (g/ra't/day)
.
6 - 16
0
30
100
soo
0/24
0i29
1/28$
0/26
a1 :2+-2 .,b
2ze .4+3 .5
22 .1¢z .4
2z .o±z .o
22r4±4 .5
23 .4¢3~0
22 .2±2 .3
19a6±2 .1
26a1+5~T
26~C1t2o5
25 .1±2 .5
23 .2±2 .4C
25 .4±5 .2
26,4±2 .5
25 .5±2 .9
24 .2±2 .4
28o7¢2a5
29 .3~'3 .1.
28a5±2 .6
29 .L2 .I
24 .6±303
2503±2 .3
24~4±2>5
22 .6±1 .9c
c
00026
Hydroquinoae - Developmental Toxicity Study in Rats
Mean Terminal' Body and Organ Weights
30
].00
0/29
1e28'
0/26
305 } 29
296 ± 25
291 ± 20
10 .91¢1<06
1.0 .51±1 .01
10 .56±0 .87
3>59¢0 .20d
3 .56±0a21
3 .52t0 .1.7d
1 .96±0 .-19
1 .91±0 .21
1 .92±0-16
OvbS¢0 .06
O .bS±0<d6
0 .66t0 .05d
300
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Table 7
Hydroquinone Developmental Toxicity Study in Rate
Summary o9
External, Internal Soft Tissue end Skeletal F-4oatw . tiona of FetuaeQ&
.
Total p=A='n " d :
-
External
Soft tissue
Skeletal
0
%
-Peruses30
100
8 No .
S %o .
Pao .
100 312
50 156
50 156
External d2t~a~tioas e
~ j4 zona
Soft Tissue Alterations :
Dilated zxaal pelvis
Hydronephzomix
Hydraurxsmz
Miapoaitiased Subclav4aa Axtergb
Diaphragmatic Hezniab
p
1
1
2
3
1
y
10
5
15
10
2
3
Man-ossification :
Hyoid
Pzeaphmoid
Total Skull Alterations:
g
1
15
1
23
Wary/Knobby
Shortened 13th
3
4
14th thnsacolusbaz (Rudimentary)
2
3
2
1
3
2
100 295
49 146
51 149
1
¢
4 ( 7~
2
1
Skeletal Alterations :
Skull
242cxognathiab
Ealazged Yoneaar_L]et
Partial Ossification :
Palatine"
6
1
Total Soft Tissue &lterntSouaa
Hyoid
Membranous bones
100 349
50 175
50 1?4
2
3
g
1
2
3
1
3
6
7.1
10
1
.
5
17
2
'
~7?
4
~
Steraebrae
<4 Ossification nit¢aC
B12nbed
Split
13
9
20
6
1
1
13
21
2
3
1
2
19
Partial oeeifisatlom (41-3)
18
28
14
24
Non-oae4ficatioa (01-2)
Bilobed (mainly 69-13)
1
37
1
58
2
33
3
57
Partial ossification (11,12 or 7.3)
Split (010,11912)
1
1
"bar Arches :
Partial ossification (IS-b)
Lumbar C¢ALYt¢:
Dllobsd 02)
Sacral Arches
:
Partial ossification (mainly
i3 and 4)
Sacral CoatYae :
Partial ossification (mainly
93 and 4)
Total Ber¢abtal Alterations :
Pelvic Girdle
?srtlal ossification (pubis
and/or irclcim)
rif4catioa (pubis)
1
1
Metatarsals
6 10
16
9
1
2
17
7
5
2
22
6
12
8
2
21
6
33
9
4
1
4
1
46 3-1
29 7
13
3
2
3
32 48
1
2
9
1
7
2
37 10
22 6
`
1
35 10
68 13
13
3
26
22'~~
9
3
3
3
1
1
1
3
1
15
G
35
19
4
5
4
42 11
a
Z
6
1
15
4
4
6
1
1
8
4
2
1
4
1
54 13
45 13
41 11
50 13
4 1
88 21
10 3
72 21 "
11 3
78 21
89 23
3
2
3
2
1
i
2
79
69
58
40
64 i111 .
1
56
1
94
1
71 114¢a ;
3
%
6
1
1
4
4
7
1
1
2
1
1
2
94
31
3
4
4
1
1
43 64
61
1
1
2
a
6
1
35
2
41
63
7
3
13
4
b y,
58 15
13 3
9 2
81
1
2
4
4
3
2
47
1
12 l~3:)
2
1
60
68 119
1
1
1
22
100 26
100 26
100 26
4
1
1
1,3~e
100 28
100 27
100 27
1
13
9
100 29
100 29
100 29
300
No .
3
5
1
100
No .
1
3
Y
-Lit ters-
30
Z No .
4
1
39
64 107
100 24
100 26
108 24'
1
Z
1
18
»~ ,
~9~
*
1
6
0
s
6
Y
Extremities
Partial ossification
Total Skeletal Alterations*
2
2
9
5
Vertebrae
Thoracic Contras :
g
3
13
1
1
3
2
1
2
1
1
2
1
12
19
l
3
8
1
`YD
i
100 321
50 160
50 161
4
11
6 ~~
No .
1
Ribs
missing 13th
Shortened 9th-13th
300
Z
75 120
4
4
1
7
2
3
%
7
2
S,
g
4
g
1
22
3
6
2
B
2
77, 17`
69 20
67 13
69 1d
88 21
90 26
4 ,P.
85'23
4 -1 .
96 25 ,
17
4
21
BS
4
fl
4 1
92 22
I
a! single ferns may have more than ona defect, therefore t he sun of the individual
defects any not equal the total n umber of fetuses with defects .
bCvun4dered a major malformation .
CAS least four well ossified sites s hould be present in th e 20 day old rat fetus .
Thus, less than b sites present S s considered abnormal .
Partial and nomm-ossification
of Individual mearsebrae were rec orded and no differences were seen between the
treated and control groups (sQa Individual data, appendix 6),
t1amded-off percentage vas less tham 1 .
**Statistically different from contr ol, X2 table 2 X d and Fisher'* Exact Test (sd) .
- ---- .
- - -
6
3 1
3 1
93 37
4
7 2
4 1
89 24
19
5
8 2
100 26
'V l.J iJ ~
Protocol fog a Teratology Study of Hydroquinone in Rats
00030
.. _
.
.
,
.
APPendi.x 1
Page 2 of 17
acclimated to the laboratory for at least two weeks prior to
-
mating .
Hales and females will be mated ]. :I over approximately a
two-week period in order to obtain 120 Inseminated females .
'
a
'
Copulation w312. be verified by daily Inspections for the appearance
of vaginal plugs and the day a plug i~ seen
11
considered day A
of gestation .
.
Ac the females become Inseminated, they will be assigned on the
a
-
.
,
.
.
.
`
Appendix 1
Page 3 of 17
Experimental Design
Maternal Observations
The dams will
observed twice daily (except veek.°endr) on
con-dosing days and predose (a .m .) and post-dose (p .m.) on treatment
days (days 6-.15 0f gestation) for mortality, morbidity, and clinical
signs of toxicity .
Animals found dead or moribund will be examined
for gross - pathologic changes and the condition of the uterus will be
noted .
Individual body weights of the dams will
recorded on days
6, 9, 12, 16, 19, and 20 (termination) of gestation .
Feed
consumption will be measured on days 6, 9, 12, and 19 of -gestation .
.
.
.
.
"
06031
~ppendix I
Page 4 0£ 17
_
Fetal Observations
On day 20 of gestation the dams will be anesthetized by
Inhalation and the abdominal viscera
Incision through the abdominal wall .
determinations, the ovaries will
11 be exposed by a mid-line
Following body weight
removed, identified as to right
or left . and the corpora 3utea of pregnancy will be counted .
uterine horns
counted a
11
2
opened and the i=plantxtion sites
The
11 be
categorised as viable fetus, dead fetus, early
'l9 U
~FP endix 1
Page S of 17
-
viable, dead and resozY>eal fetuses within each born will be
multiple range test when the -F' values are significant .
Analyses
of other data will be done using appropriate parametric or_
nan°paz:metrqe techniques .
.0034
0
Fetal body weights (mean of the litter means I SD)
Sex ratio of the fetuses (M :F)
Percent pre-implantation loss ~
.
(Numlrer of Corpora Lutea - Number of Implaatatioas)
Number of Corpora Lutea.
Percent gost°inpIantat3on lost
(Number of Implartationc - Number of Viable Implants)
Number of Implantation~
Z 1~~
maternal body weight, feed consumption and clinical signs Of
t
city
Materna l hetologic and clinical chemist ry findings .,If any
Results of external, internal soft tissue and skeletal. .,
examinations of the fetuses
Anoma lies will be listed and the incidence 4n toth fetuses and
litters involved will be indicated
Absolute and relative organ weight data
.
- 003 r
0
Appendix 1
Page 7 of 17
Gross pathologic examination of dams and results of
bistopathologic examinations
Testing Facilite and SiDrancor
W.To Kracaeage, ?f .Sm
The study will be conducted in accordance vith
Good Laboratory Practices .
e sponsor of this study Is the
Chemical Manufacturers Association, Washington, D.C .
30 Walker, D . G . and Wirtachafter, L . T., The Genesis of the Rat
Skeleton , Charles C. Thomas, Springfield, II., 1957, p .
.
-
Appendix -1
Page 8 of 17
Protocol Amendment No .
Title :
Protocol for a Teratology Study of Hydroquinone in Rats
Project No . 83-0155C3
Accession No . 900356
'ChanEe and Rationale
Amendment No . 1 Reviewed and Approved by :
--
Walter J .
avage, ?i.5 . Tatologi.st
Study Director
.
M. S . 'James ; Codi
Quality Assurance U t
619
. AL
Cm Jm er aaar, Pflx .D., Supervisor
-Toxicological Sciences
,
Date
-- ~.~.~znjDate°-
--
Date
a
3
S
f
1
bVPOCC 0"
PefT06ASlZZ Wo+C40XDC gV6iBAtaC[z
.. .
0
J.
Kodak
ieri8aar v
Park
SL! e3J .
Building 320
Rochester, New York
~ ..
14650
~
~
~~
..
.
Dear Dr . Terhaaro
discussed by telephone, I am suEsmitting ~ ta you the
results of the OTS review of protocols for' the following studies ;
reproductive effectse tera tolo, dominant lethal, and
toxico3ciraeticsm
Once you an
yoLar staff have reviewed these, if
there are further questions, please contact me to set up a
meeting with the appropriate staff .
Dominant Lethal
Positive control . The adtivity of Apholate in the
dominant lethal assay should be documented either by
reference or by (submission) of data from the laboratory
which will perform the assay .
-
Appendix I
Page 9 0£ 1?
Protocol Amendment No . 2
Title :
Protocol for a Teratology Study of Hydroquinome in Rats
Project No . 83°0155G3
Accession No . 900355
Reason for Amendment
Additions : Page 2, paragraph 1. - Add that the rat was selected as the
test species, because it is commonly used in teratology studies and it Is the
.4 guidelines for teratology testing .
primary rodent species recommended In
Page 2, paragraph 3 - Test Animals -a Add that the
manufacturer's analysis oaf the basal diet and periodic analyses of the
drinking water indicate that no contaminants should be present in the food or
water that may compromise the results of the study .
Page 3, paragraph I - Route of Administration - Add that
gavage was chosen as the route of administration because ofthe low vapor
pressure and minimal dermal absorption of hydroquinone .
Page 7 - Testing Facility - Add that the start date of the
d that a final report will
study will. be the date on which breeding begins
be 3ssued within 9 months following the start date .
Amendment No . 2 reviewed and approved lay :
a avage$ M .S . T ~atologitt
Walter J .
Study Director
Date
--Ma Sn James, oordinator
Quality Assurance Unit
. . .2 a, l
Date
Cm J T`ezhaar , . Ph .D ., Supervisor
Toxicological Sciences
/
.4 '
Date
00039
~'Ago a>4,eo
Appendix 1
}'age 12 of 17
t
UNITED STATES ENVIRONMENTAL PROTECTION
AGENCY
WASHINGTON, DotCm 20460
osrsct of,
rcSveceacS arcm
TOXIC suasYAevCcs
Dr . C . a7 . Tezhaar
Health and Environmental Laboratories
Eastman Kodak Company
1669 Lake Avenue
Rochester, N .Y . 1.4650
Dear Dr . TPrhaar :
Enclosure
00040
eappenaix
-
1
Page 11 0f .17
Tox ico3cf raetics
. While Kodak itself t can conduct toxicokinetic studies with
0004
.~
.
.~
r
:
UNITED STATES EiZVIROtltviEN TAE
. PROTECTION
WASHINGTON, D .C0 2fY460
a
-
` Appendix 1 :
Page 13 0£ 17
AGENCY
00
042
,
-Appendix 1
Page 14 of ~I-,
Appendix 1
Page 15 of 17
.
.
CHtMICAL MANUFACTURERS ASSOCIATION
8
GERALDthPE V CoK, i'8a.S9.
Vice President
Technical Director
October 16,
1984
. David J . Price
Project Manager
Test Rules Development Branch
Office of Pesticides and Toxic Substances
Um S . Environmental Protection Agency
20460
Washington, DaC .
Dear Dr . Price :
~ Fwmarly Manufacturing Chvmsteli Atsc~c3stiAn-Sarvlnp the Chamlral Industry Since 1572-
we-0 as ee .m .a e.t~At e iR9&tY,ovoe9fes~1
I e Z'o1e°'~ ""w° ~t°°a~r~.t
e TOIor
..
18 f~1.4~ VV$F11
00 ~~ m
.
A0
0 0
-
0
4
5
.
J°o m
y, ~a,
9`d~
.
.
.
.
orrese or
r~tssce~~a AND
TOXIC MUyST^MCMS -
.
v s:~s` . .
RiCha8 d
Tr0ast
Test Rules Development Branch
s
'
Apgendrx 2
Page 2 of 16
S
INSPECTION STATEMENT
[Reference 23 C
58°35 (h) ('i)l
Industrial Laboratory KE5H031
3155
Accession #900356
Title :
dr uiraorae
say lot A-13
d Final Report
Method
d 5% Water Solution Predoses,,LsCo
e data, records and methods for the final report of above analyses were
audited on March 22, 1985 .
e audit showed that there were adequate written procedures for
conducting the tests and that the equipment used in these tests was in
good working order, and calibrated according to schedule .
enla
3/2'7/85
090gai0005a
00047
ESWznla
9/20/85
ead
9t~
Quality Assurance
Quality Systems Services
~ 0033n
000
.
,
A endix 2
Page 3 of 16
INIl . LAB . FILE ~ e
EESH024
DATE :
713t/65
TITLE : Hydroquinone Lot A13 A5say by 6C/FID and HPLC
AUTHOR :
Linda h . Terscgno
5P,f1PLESriLABELS AND DESCRIPTION)
Hydroquinone Lot A13
b
073185
00049
D .41
5i
RUN #
312
.}wN/29/85
FILE ID= C
RKFI 1.E NAM E :
SALE
9
R%
RT
9 .85
.89
1o
6 .41
.
AREA TYPE
122m D
2 .6117E +07
51912
1 . 729 6E+-9 7
SRB
12 : 40 -- 46
.
AR/Hl
9 .618
9 .853
9 .844
" .187
AREA::
~ .278~SD ~'~`'
66 .646
8 .117- °°~
39 .5549-
TOTRL
R= 4 .3496E +97
+
FACTOR= 8 .
00
Appendix I^
Page 5 of 16
.
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Page 8 Of 16
.
'
INDUSTRIAL LABLkRATORY
REGISTRATION MO .
ACT . NO. ~
REVIEW POINTS
DEPT NO .
8LOG
PHONE NUMBER
FEREFdCE NO.
ixR
-No.
SAMPLE COD*
3
fzoltl 1A
S^MPLE DESCRIPTION
u_I~IeIYI
7003,~-6
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SAMPLES
~ va+isOF
REQUEST
IDENTIFICATION NO.
SPEC . OR 5YD . TEST NO.
PI)RCHASE ORDER NO .
VENDOR
{
!
DESCRIBE PROBLEM AND ACTION YOU REQUEST .
ATTACH SEPARATE SHEET IF NECESSARY
REPORT OF RESULTS AS FOLLOWS :
The submitted sample was analyzed for Hydroquinone concentration
according to ILT # EH83-I24 .The original data will be kept on file in the
Indm Lab . The results are as follows :
~Cl X Hydroquinone s 5 .0
n _ 4
a Q 0 .41
0--e .
'
Ic:Di:S3'F~ .L LAvORATOr~'e REFG : .-" C-4
00054
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NO. OF SAMPLES
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SPEC. OR STD . TEST NO.
PURCHASE ORDEA NO .
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1
DESCRIBE PROBLEM AND ACTION YOU REQUEST .
ATTACH SEPARATE SHEET IF NECESSARY
2. -~
i
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t'B-'7"'
.
~` l~G rc.'t
c7
AFVnR7 nF RESULTS AS FOLLOWS:
The submitted sample was analyzed for Hydroquinone concentration
according to ILT # EH83-124 . The original data will be kept on file in
the Ind . Lab . The results are as follows :
x ' 5 .0 y Hydroquinone
s, = 0 .21
n = 4
i^!f1~~CTP foi
.
aaana-' T!1?`1' Fr°^7 ' CO P ;f
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Page 11 of 16
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IiJDvSTR°.-^,L LABORATORY R=?v7T COPY
3 11 0
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Page 13 of 16
.2 1TIMai~-WLWA-
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REPORT RESULTS TO :
NAME
110
161(%l
SLOG
DEPT No.
t
EKR No .
SAAMPLE CODE
I
POINT
ACT. No .
Ac
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LW
1
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DEPT
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INDUSTRIAL LABORATORY'
REGISTRATION NO.7
AMIGNEDTO :
DATE RECEIVED
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A. F
CHARGE NUMBER
REFERENCE NO.
Ti l 19 1
10 L
SAMPLE DESCRIPTION
Til l
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ACCESSIOt4NO.
NO . CF SAMPLES
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SPEC. OR STD . TEST NO. :
VENDOR
.
DESCRIBE PROBLEM AND ACTION YOU REQUEST,
ATTACH SEPARATE SHEET IF NECESSARY
IURCMASE ORDER NO .
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o~v
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REPORT OF RESULTS AS FOLLOWS :
t 'oC
CA r+ Ce.n't'Covi Ion
<D 9 vld~cn ~.
Pos~ ~~~
The submitted sample was analyzed for Hydzoqeinone concentration
according to ILT # EH-83=224 . The original data will be kept on file
in the Ind . Lab . The results are as follows :
x = 5 .0 X Hydroquinone
s - 0.05
n - 4
~+au~aooo ~
.
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Page 14 of 16
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The submitted sample was ' analyzed for Hydroquinone concentration
according to ILT # EHS3-124 . The original data will be kept on file
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x ~ 4 .8 x Hydroquinane
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'
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.
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Page 16 0£ 16
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Appendix 6 ;
Page 12 of` 12
~ , ,1
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.
OFFICE OF
PESTICIDES AND TOXIC
SUBSTANCE:
Geraldrne V . Cox, Ph~C7a
Vice President and Technical Director
Chemical Manufacturers Association
2501 Pe1 Street,'NmV1' .
Washington, D .Co
20037
Dear Dr . Coxm
Document Control Officer
(TS-793)
ATTN :
Mr . Terry C7'Bryan
Office of Toxic Substances
U .S . Environmental Protection Agency
Washington, D~Cv
20460
The Agency looks forward to continued cooperation
with the
Chemical Manufacturers Association in its efforts to
evaluate
potential risks posed by chemicals to health and
the environment .
S incereiyp
Enclosure
CC .,
Lee M . Thomas
Frank D . Kover, Chief
Chemical-Screening Branch f ECAD
January 24, 1986
~~~--
Sincerely,
1/1 11 ,
°`/ ~-
- -~t ~
7
Ir
Formerly Manufacturing Cheinists Association-Serving the Chemical Industry Since 1872 .
2501 M Street . NW a Washington, DC 20037 o Telephone 202/897-t1Q0 * Telex 89617 (CMR WSH)
00001
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