Document reRkkoRqYX0yraaQZYOdwLwJv
ACUTE TOXICITY TO FISH (FATHEAD MINNOW)
TEST SUBSTANCE
Identity:Perfluorooctanesulfonylamido(ethyl)acemtaaytea;lsobe referredto as PFOSAA, FC-1 28 oras the major component of FC-1 27, FC-1 29, FC-1 09, or FC-1 09-X. (Glycine,N-ethyl-N[(heptadecafluorooctyi)sulfonpAo]t-a,ssium salt,CAS # 2991 51-7)
Remarks: The testsample isFC-109-X referredtoby the test laboratoryas E2566-2. Currentinformationindicatesitisa mixtureof 1923% testsubstance,61 % water,12% 2-methoxyrriethylethoxypropanol, 2% ethanol,and 2-6% C4-C7 fluoroalkyclarboxylatecompounds. Test materialwas from 3M productionlot2.
The followingsummary isabbreviated because the testsample is a mixture of the testsubstance in a waterlorganic solventsolution. Data may not accurately relatetoxicityof the testsample with thatof the testsubstance.
METHOD:
Methods: OECD 203 Test type:Staticacute GLP: Yes Year Completed: 1988 Species: Pimephales promelas Analyticalmonitoring:Temperature,pH, DO Statisticaalnalysis:LC5o valueswere calculatedusingthe program developed by Stephan etal.
RESULTS
Nominal concentrations: Bk control1,0,18,32,56,100,180, 320 mg/L Element values: 96-hourLCBO = 57 (36-93)mg/L
96-hour NOEL = <10 mg/L
Allelement values based on nominal concentrations.
Remarks: Testingwas conducted on the mixtureofthe testsubstance as describedinthe testsubstance remarks field.The value reportedapplies tothatmixtureand not the testsubstance. No attemptwas made to determine the impact ofthe presence ofthe organicsolventsorwhat portionofthe toxicitcyan be contributedtothe Perfluorooctanesulfonylamido(ethyl)acetate.
CONCLUSIONS
The FC-109-X 96-hourLCroforPimephalespromelaswas determinedto be 57 mg/L witha 95% confidenceintervaolf36-93 mg/L. The 96-hourno observed effectlevelwas <10 mg/L.
Submifter:3M Company, EnvironmentalLaboratory,P.O. Box 33331, St. Paul,Minnesota,55133
DATA QUALITY
RellabliftyK:J!mischranking2. Testingmeets all'critedafqourality testingb,utlacksanalyticaclonfirmatioonftestsubstanceconcentrations. There isa lackof characterizatioofnthetestsample.
REFERENCES
:Thisstudywas conducted at AnalyticaBlio-ChemistryLaboratoriesI,nc.of Columbia, Missouriatthe requestofthe3M Company.
OTHER
Lastchanged: 5/17/00
SIONSOR 3M Company Attn: Mr. Mohamed Elnabarau-y EE & PC Environmental Labs Building 21-2W-05, 900 Bush Avenue St. Paul, Minnesota 55106
STUDY TITLE Acute Toxicity of E2566-2 to Fathead Minnow (Pimephales promelas)
DATA REQUIREMENT OECD Guideline 0203
AUTHOR Jane H. Bowman
Biologist 11
STUDY COMPLETED ON January 12, 1988
PERFORMING LABORATORY Analytical Bio-Chemistry Laboratories, Inc
Aquatic Toxicology DivLxion 7200 East ABC Lane P.O. Box 1097
Columbia, Missouri 652 05
ABC LABORATORY PROJECT ID #36617
Page I of 63
Submitted By:
Anal@yticalBlo-Memistry Laboratories. 7200 E--st ABC '-z--e P. 0. Box 109'1 Col=bia, !11-ssouri (-5--C5 (314) 4"4-8579
Irc.
Prepared By:
jare 'A. E,,w--an
Date
La@-.ra MulleBiolcgist
Approved By:
Date
:dab3l
J=.fs P. Swigeit. Fh.D. Su"'er,.rsor.Fish Acute/ Chronic 'Lavestigations
phillil@ M. Buckler
Quality Assurance.Supervisor
L/ Carl M. Thompson
Aquatic Toxicology
Manager
Date.@ Bat&
ABC LABS #36617-2 of 63
TABLE OF CC.%@a---%-TS
?are \o.
LIST OF ILLUS-4iLkTIONS . . . . . . . . . . . . . . . . . . . . . .
PROJECT PERSO.N\EL . . . . . ... . . . . . . . . . . . . . . . . 3661'1-5 FISH ACUTE TO.KICITY CC,!,2=IUM . . . . . . . . . . . . . . . . . 366?A,--6
ST!,YARY . . . . . . . . . ... . . . . . . . . . . . . . . . . . .6.617-7
. . . . . . . . . . . . . . . . . . . . . . . . . . -.6617-8
,Mr-nCr,S A.\D X-t@tERIALS . . . . . . . . . . . . . . . . . . . . . . 7-6
1. Test F!sh . . . . . . . . . . . . . . . . . . . . . . .
Test !Oaterial . . . . . . . . . . . . . . . . . . . .
Test Water
. . . . . . . . . . . . . . . . . . .tbl7-9
IV. Biological Test Proce%4ure . . . . . . . . . . . . . .
V. Biological, Data Aualysis . . . . . . . . . . . . . . .
REST;LTS . . . . . . . . . . . ... . . . . . . . . . . . . . . . 36617-10
LITE.UIURE CITED . . . . ... . . . . . . . . . . . . . . . . . . .'6bl7-16
QU.-LITY A.SSUPA.VCE STAiEKEi.-t,
36617-17
STLDY CL%14PL'LA.%;CE
. . . . . . . . . . . 36617-18
ABC L.@BS ;@36617-3 of 63
LIST OF U.IZSMA:@"-rC-.%S
Table No.
rd4e No.
I
Che=ical Characterist-,@.scf Wel-' 1;att.'-se@t
by ABC's Aquatic TomicoleLT Di.%,!S!o.t . . . . . . .
2
Acute Toxicity of E2566-2 t0 F&t%tJd
(Pimephales Prei2elas)
3
Mortal-@.tyRates ard Water 4zmall-tv
Purirg the Acute Toxieltv -lest0:-
Fathead Mluncw (Pimphal;s @.rc=ela-..7 . . . . . . . .
Fi,zi:re%o.
Slope of Dose-Resporse '-,.Ccat Si.@ E2566-2 to Fachead Nium-w (Li=e2 pro=elas)
ABC !-A."03661?-4 of 63
PROJECT PERSO.%!%EL
The ottidvdirector of the project for Analytical Bio-Chemistry Laboratoriess Inc. was Ms. Jane H. Bowman, Biologist ll.. Supervising the conduct of the study for 3H Company was Mr. Mohamed Elnabaravy. The following ABC personnel assistedwith various phases of the study.
%lame .7.-.nHe. Bowmar. Laura Mullen Chris Brenneke Jame,;P. Swigert, Ph.D.
Title
BiologistIl Biologist1 Biological.TechniciaIfi Supervisor,Fish Acute/ Chronic Investigations
Initials 1'.
ABC I.ABS 436617-5 of 63
FISH ACLrrE TOXICITY COMPENDIL.N
Sub44ct: "Acute Toxicity of E2566-2 to Fathead Minnow (Ile2phales promelib)." ABC S:udy Number 3661'17.
Sponsor: 3,MCompany
Testing Fac4@lity:
Analytical Blo-Chemist,-y Laboratories, Inc. Aquatic Toxicology Division P.O. Box 1097I Columbia, Mis souri 651&05 (314-474-8579)
Locaticn o,-@Orivinal Raw Dara.and.Final Report:
3M Company St. Paul, Minnesota
55106
Test Mattrial: E2566-'4*
,testConcentrations: Control, 10,.',18,32,,56, 100, 180 and 320 mg/i ,
DiltitionWater: 42 mg/i (hardness), 32 mg/l (alkalinity), 7.4 (PH)
Te.-;tDates:
ltiitlation Januar@*8,@1988.. Terminaticia@ Jaiiuary,12, 1988,@,,:
Length of Srtjdy: 96-hours
Results:
96-hour.LC so
96-hour NOEL
57 ms@l (95Z C..I.@@-!.,36-93mgil) Im
.96-hour Slope a t@e.; ose-@R esponse Line was.16'.
Test Species:
Fathead Minnow (Pimepl,-ialeparomelas)
Soure,@ of Organisms@ ABC Laboratories in@-house culture
Mean Weight: 0.061 g (tU.037 g) %.ean Length: .17 (t2.2
ABC LABS #36617-6 of 63
FISH ACt-rE TOXICITY CO-MPMIL-LA
Subiect:
"Acute Toxicity c-fE2566-2 to Fathe3d '4innew (PineiDhales promel.:s) ." ABC Szudy ?;=ber 3661.-.
Sponsor: 3M Compary
Testing Facility:
Analytical Bio-aemist--v Lai@crato@-les,Inc. Aruatic Toxicology D!risio=
P.O. Box 109' Colu=bia. Mi;souri 6:-@-'0(3314-474-8579)
Locaticr. L,.,t*)riizirj'R.aw Data and Final iepcrt:
3M C4@=p3nV
St. Paul. Minnesota
55iO6
Test Material: E.151"fl--,
Test Concentrations: Control. 10. 18. 3@-.56. 100. 180 and 3d'O ns/I
Dilutioti'.;ater:42 -ag/l (hardness). 32 ni'l (alkalirity). 7.4 (PP)
Test Dates:
Initiation Tezzinatlon
January 8, 1988 January 12, 1988
Length of Study: 96-hours
Results:
96-hour LC 50
96-hour NOEL
5," mg/l (95Z C.I. <10 mg/l
36-93 mgil)
96-heur Slope of the Dose-Responsi@'Line was 16
Test Species: Fathead Minnow (Pimepl-ales pr,-nelas)
Sourci of Organisms: ABC Laboratories in-house culture
Mean Weight: Mean Length:
0.061 g (10.037 g)
17
(t2.2
ABC LABS -r",SE617-6,of 63.1
SL%VARY
The acute toxicity of E2566-2 to fathead minnow (Pimephalgs proselas) was assessed using the method$ Outlined by the Co=ictee on Methods for Toxicity Tests with -,Aquatic Organisrs. Water quality parameters of temperature. dissolved oxygen and pH were measured throughout the test and were within acceptable limits. Culture and ac-climationrecords Indicated'the fish were in good condition for
testing.
The study was conducted at the following nominal conce-itratiorsof E2566-2: 10, 18, 32, 56, 100, 180 and 320 mg/l. At 0-hour, the 18, 3Th2e. 56, 100, 180 and 320 mg/l solutions had a white @-urfacefilm. amount of surface film increased with the concentration frc%=a %-ery slight amount in the IS mg/l solution to a thicker, nearly complete covering over the 320 mg/l solution. After 24 hours, a slight surface film also appeared over the 10 mg/l solution while the other solutions had a surface film increasing with the concentration. At the 72- and 96-hour observations the 100. 180 and 320 mg/l solutions were cloudy and all solutions had a surface film that Increased in proportio-.tio the concentration. Ten fish. with a mean weight of 0.061 (0.037) g and a mean standard length of 17 (2.2) =m. were ftxposed to eact@.test concentration and control.
The results of the four d -static fish toxicity study using
E2566-2 are s,,--grizedbelow.. The 24-,-48- and 72-hour LC values were
also determined. The 96-hour al
the dose response 12(n)weas 16.
Compound
96-Hour LC 50
(95
E2566-2
57@mg/l
(36-93 mg/1)
@Also, the results Indicated ii96-hour, no-observed effect conceim-
tratlon could be estimated at
lowest concentration tested.
Aanormal effects of mortality, surfacinsi:loss of equilibrium, dark
discoloration. fish on'-'the:bottom,.',.tOefs.t',-'c,hamber, quiescence and/or
excitabilitywere observed during the .96-ho4iexposure period in the 10,
18. 56, 100, 180 and 320 mg/l test,c-oncentrations. One fish in the
control u@amber was quiescent and oti-.the bottom of the test chamber at
the 96-hour observation.
ABC LABS 036617-7 of 63 MEMO
INTRODUCTION
-This static bloassay was performed by the Aquatic Toxicology Division of Analytical Bio-Chomistry Laboratories, Inc., Columbia, Missouri,for 3M Company.from January 8, 1988 to January 12. 1988. The purpose of this test was to determine the 24-, 4b- and 96-hour 1,C levels for E2566-2 to fachend minnow (Pimcphales promelas). 5k prolizinary range-finding study was conducted from December 31, 1987 to January 4, 1988 to determine the concentration range for the definitive bioassay. The study was conducted following the procedures outlined In ABC Protocol Number 7601 (Raw Data), as approved by Mr. Maliamed Elnabarawi, -3M Company, on Januirv 7, 1988
IAETti(IDSAND MATERIALS
The procedures for Htatic bioassay, as described in Methods of Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians (1) and Standard Methods for Examination of W;iter and Wiqtewitter (2). were used in this experiment.
1.* Tiit Fibb
The fathead minnow (ABC Lot fZ'L87 FIW) used in the test were obtained from an ABC Labs In-house culture. All test fish were hold In culture tanks an a 16-hour daylight photoperiod and observed for at least fourteen days prior to testing. Fish culture techniques used were basically thort describe4C by Brau@n et al.* (3). A daily record of fitih observations during the holding period, along with any prophylactic or therapeutic disease treatments, is Included in the Paw Data. Ditring-this period, the fibh received a scandard commorcial.fish food occasionally supplemented with brine shrimp nauplli (Artemia op.) daily until 48-96 hours prior to teuting at which time feeding was discontinued. The fathead minnow used for this experiment had a mean weight of 0.061 (20.037) g and a mean standard length of 17 (t2.2) mm. This'. gave a test chamber loading biomass of 0.041 g/l for the definitive study. Weight and length measurements were made on the control group of fish at the termination of the test and tare included In the Raw Data.
II.- -TestFactrial
The E2566-2 sample,was received on December 29, 1987, in good cordition.' The sample upon receipt wtic observed to be a foam- yellow liquid rand was stored at room temperature. Sample purity was not specified. The definitive test concentrations were obtained by transferring appropriate weights of test compuurd directl.y to the casitchambers. Al.1 tobt concentrations were based on the total compourdo i.e. not corrected for sample purity. All standard weigtits and di;ttion values are listed in the Raw Data.
ABC LABS 03f,617-8 of 63
III. Test Water
The static fish bioassay was conducted in five gallon glass vessels containing 15 liters of soft reconsrzlcutewdater composed of the following compot.,-.iindsthe a=ourts stated-per liter of delonizedwater:
48 ag N&ECO 3 30 mg CaS04. 2 H20
30 MSSO,4 2 mg KC1
This reconstituted water was prepared v e'd a total
hardness of 40-48 mg/l as CACO3- a total
of 25-35
mg/l as CACO and an initial p;iof '?.2to
7%e 0-hour
measured
3 control@water
parameters
of
this d4.lut4-c-n.@aterwere
dissolved oxygen 9.3 mg/l and pH 7.4. The we!'-water source
freniwhich-this dilution water was prepared ha,!the charac-
teristics shown in Table 1.
,Lhe test vessels were kept in a water ba,,hat 21-*C (I.O). The test fish were acclimated to the dilution water and test temperature and held without food for 4S-96 hours prior to testing. An acclimation record is included in the
Raw Data.
IV. Biological Test Procedure.
. A ranga-findi-ngtest of 96-houre duration was conducted to determine the concentration rang for the definitivestudy
The preliminary.test concentration: were set at 30, 100,an; 320 mg/l... Based on the results of preliminarytesting, seven concentrations-of .the test compound, ranging in a log2ritI.-mic series from.10 to 320 mg/l, with ten fish per concentration
were.selected for the de.f,:nitivbeioassay. Also included was a. dilution water,-,control.- The fish were added to the test chambers by random assignment within 30 minutes after addition ..oftest material., All test organisms were observed once every .24 hours for.mort4l@ty and abnormal (sub-lethal)effects. An dead individuals,were. removed from the test *chambers :eac!i24-@bourobservation.
V. Biological.Data Analysis
Statisticalanalysis.of the concentration vs. effect data
(generallymortality) was obtained by emploving a computerized LC@o program developed by Stephan iet al. (4). This program caculated the LC statistic and its 95 percent conridence
JJM@4CS USIC the 9?nomial. the moving average and the'probit tests. However, if no'.mortalityoccurred or if- a dcse response could not be demonstrated over a reasonable range. (<37 to --63%).an LC so and/or its 95 percent confidence limits
ABC LABS #36617-9 of 63
could not be calculated. Three differentmethods'aianalyzing
ti.dta:ta were used since no one method of analysis is appro-
pri.-tefor all possible sets of data that =ay be obtained.
ihe methld of calculation selected for presentation in this report -.@atshat %-hichgave the narrowestconfidence limits for
the IC (4, 5) although all t@ree models are valid. - The 50
concentration-mortalitycurve was constructed for the 96-hour
mortality data. The slope of the dose-response line was reported as calculated by least squares recression analysis
(log of corcentration vs. probit transformation of percert nortality).
RESULTS
Ttieze@,L,:rcsf the 96-hour static tox4@cit,t,erst with fathend minnow (Pi-nephaleSDromel3s) exposed to E2566-2 are p:esented in Table 2. '.be 24-, 48- and 9b-hcu.-LC values i."oErZ566-2 were >320. 160 and 57 mg/j, respectively. -ihe 96--loourslope cf the dose-response curve was 16 (Figure 1). All,results were based on the nominal concentrationsof 10, "si 32, '6, 100. IBU and 320 L-g/l. At 0-hour. the 18, 32, 569 @100,11-810 and 320 mg/l solutions had a utite surface film. The amount of surface film ircreased-,:i:hthe concertrationfrom a very slight amcimt in the 18 mgll solution to a thicker, nearlv complete covering aver the 320 mg/l solution. After 24 hours a sligir surface film tlao appeared over the 10 mg/l solution while the other solutions had a surface film increasingwith the concentration. At the 72- and 96-hour observations the 100. 180 and 320 mg/l solutions were cloudy and all solutions had@ a surface film that increased in proportion to the concentration.
The 96-hour no-observed effect concentration was estimated to be
<10 mg/l. the lowest concentration tested. ' The abnormal:.ef fects of
mortality, surfacing. loss of equilibrium. dark discoloral:61onf.ish'on
the bottom of test chamber. quiescence and/or excitability,were observed
in the 10, 18, 56. 100, 180 and 320 mg/l test concentrations.during,the
96-hour exposure period. One fish In the control chamber.was..quiescert
and on the bottom of the test chamber at the 96-hour observation. -@The
10 mg/l cliamberalso had 202 mortality at 96'hours while the-Is and 32
mg/l chambers had OZ mortality. An examinationof the fish c ltur ind
acclimationrecords for this test Indicated that th.e
were itt'good:@
conditionfor testing (Raw Data)
Nominal test concentrations. mortality rates and water qua lty...4,.ata -are -presentedin Table 3. The dissolved oxygen concentiittoins ranged from 6.8 to 9.8 mg/l during the test. These values represented 81'and,
117% saturation at 22*C, respectively, and were considered.adequat,e testi*ng-.1),tberefore, the test char-berswere. not aerated 'during testing. The pH values ranged from 7.2 to.7.9.
ABC LABS #36617-10 of 63
I The study was conducted following the intent of the Good Lab oratorv Practice Regulations (6) and the final report was reviewed by Analytical Bio-Chemistry Laboratories' Qualit3, Assurance Unit. All original raw eata was provided to 3M- %^o--panv.with a copy retained at Analytical Rio-Chemistry Laboratories.
ABC LABS #36617-Ii.of 63
TABLE I
Chemical Characteristics of ;;allWater Used bv ABC's Aquatic Toxicology Division.
Parit-eter Temperature Dissolved Oxygena pH Hardness (CACO
3 Alkalinity (CACO
3 Conductivity Total Organic Carbon Suspended Solids Aluminum Arsenic
Boron Cadmium Chromium Cobalt Copper Iron Lead @.Mercury
Nickel Silver Zinc ilea'suredorganaphosphorus pesticides Measured organochlorine pesticides plus PCB's
Concentration b
17 - 22*c 9.1 vPM b
7.6 - 8.4b 206 - 275 ppmb 224 - 336 pp=b 500 - 650 -.@=hostcm 1.4 ppoc (0.9 - 2.8 ppm)d
b 0 - 1.3 PPM
<10 ppb <1 ppb 2.25 pp= <3 ppb <7 ppb c3 ppb <3 ppb 14 ppb
<30 ppb 0..'#3ppb
<8 ppb <4 ppb 2 ppb
<0.14 ppb
<1.0 ppb,
a After aeration
b RerTesents
seasonal
variation, difference from one
month
the next, will not exceed 102
cAverage of all well water values from January-September.
d ,Total monthly range of organic carbon
to 1987
Sample dates: Trace elements - June 3. 1987. organophosphate and organochlorine analyses !lay 28. 1987.
ABC LKBS i@36617-12 of 63
TABLE 2
Acute Toxicity of E2566-2- to Fathead F-Innow (Pimephales promelas
Compound F2-;66-2'
'@4 hours (b)
>320
LC in =illigr--/liter(ppa) 50
48 hours
96 hours
(3) 160
57
c (120-210)
(36-93)'
N 10 fish per concentration.
a Blcassay as conducted at 22*C (tl.O). man 0.061 (to.037)g and 17 (2.7)mm.
fish weight and Iangth,
b LC
could not be calculated due
50
c 95Z confidence limits.
to insufficiert=rtalitv data.
The 96-hour no-observed eftect concentration could be estimted mg/l.
at .<10
The .96-hour slope of the dose-response' line was least squares regression analysis..
16 as calculated by
All values were rounded to tw6 signifi@tut:..i-gfures."following ABC'S.O.P.
LC calculated using: 50 Binomial Method (2)floving Averag e Method (3)Probit Method
ABC LABS #36@17-13. of 63
TABLE 3
MortalityRates and Water Quality Measurements During the Acute Toxicity Test of E2566-2 to Tathead Minnow (Ptatplialespromelas)
ConcNeonmtinraaltion Control
Percent Mortality ---Hour
_L4
8
96
0
(k
0
0-liours
Temp. C
D.O.8
Sll
LHb
22
9.3
1.4
War
ty
o48r-N1lo.,Ull!
Temp. D.O.
*c
IH
22
8.2 7.4
96-hotorp
Temp. D.O.
c
t-gli PH
2.1 9.1
7.5
10
0
0
20
22
9.2
7.5 22
8.2 7.4 22
7.4
7.4
is
0
0
0
22
7.5
7.4
10
32
0
0
0
2
9.3
7.5 22
7.5 7.3 22
6.8
7.2
by
56
0
10
30
2
7.0
7.3
100
10 100
22
9.5
7.6 22
7.5 7.4
pi,
-0" 50 100
22
.7.4 7.3
'320'..,
ioo loo
22
9.8
7.9
. ...
s@,ve @ozyg*a@.e6aiisitrations, Los* v*4 Ox@Sou Probe (YSI Madel@54). (CD,r-olaNsodal 476182),-usidwith a--CorningModel 125 pH and &V motor. 4i*gei'igatu&rtl",@orietted.foraltitudeat the test temperature of 22'C
'!ti-S4;
Figure I Slope of Doze-ResponseLine at 96 Hours for E 2566-2
to FatheadMinnow (Pimerhalespromelas C!
00
C! to
'A
A,
IP7
.1b- ''7,
2.0
2.
2.4
'CO$qNTRATION_ mg
LITERATURE CITED
(1) Committee on Methods for Toxizity Tests wl@th Aqua,.ic Organisms (C.
E;. Stephan, Chair--an). 1975. Methods for Acute Toxicity Tests
with Fish, Macroinvertebrates and Amphibians.
En%,iionmental
Protection Agency, Ecological Research Series 7-PA-660/3-75-009,
April. 1975. 61 p.
(2) Americar Public Health Association. 1980. Star.@la.-dMethods for the Examination of Water and Wastewater. 15th ed. Washington, DC. 1134 p.
(3)
Brauhn, J. L. and R. A. Schoettger. 1975. Acquisition and Culture of Research Fish: Rainbow Trout. Fathead Minnows, Cha"nel@ Catfish and Bluegills. Enviro=ental Protectior. AFencv, Eco!ogical. Research Series EPA-660/3-75-011. May, 1973. 45 r.
(4) Stephar,, C. E., K. A. Busch, R. Smith. J. Burke and R. 'v@.Andrew.
1978. A cc=,-,uterprogram for calculatirg an '@C 50
mental Protection Agency, Duluth, Mir.Desota,
'*. S. Enviror.pre-,-ublication
zoanuscript, August, 1978.
(5) Stephan. C. 1977. Methods for calculating an LC 50. e- -- - Ir.
.
F. L. Maver and J. L. Hmelink (eds.). Aquatic Toxicol-og-! and
liazard Ev@luation. ASTM Special. Technical Publication 634. ASTM.
Philadelphia.
(6) (a) U. S. Food and Drug,'-Administration. 1978. Nonclinical Labciratory Studies,.@Good Laboratory Practice Regu'Aations (21 CFR, Part 58).. Federal Register, Vol. 43, No. 247:5998660 025.
(b)
U S. Enviri@amental Programs;. Good (40 CFR, Part @160).@ 53946-53969 .
Protection Agency. 1983. Pesticide Practice StandardE; Final Rule Register, Vol. 48, No. 230:
(c) U. S. Enviro= ental Prot ectio'n Agency. 1983. Toxic Substances Control; Good ..Laboratory Practice Standards; Fina Rule (40 CFR, Part 792). Federal, Register, Vol. 48; No 230:53922 5394
C46,
(d) Organization for Economic
operation and Develop--ent. 1981.
OECD Guidelines for Testing of Chemicals. Principles of Good
Laboratory Practice A=ex .2,,C(81)30(Final):7-28.
ABC LABS #36617-16 of 63
QUALITY ASSURANCE STATE14F-%"r
Quality Assurance Statement for final,report 036617 entitled, "Acute Toxicity of E2566-2 to Fathead Minnow (Pimephales pror-elas " for Mr. Mohamed Elnabaravy, 3M Companv, St. Paul, @tinnesota.
In accordance with ABC Laboratories' intent that all studies con-
ducted at our facilities are designed and iunccion in conformance with good laboratory.practice regulations and the protocols for Individual laboratory studies, an inspection of the final report for E2566-2 was
conducted and found to be in an acceptable for= by a member of our Quality Assurance Unit. An inspection of the daily mortality rate of the test organisms prior to the initiation of the studv indicated they were in good health and should not bias the ebser-ie.@-o.r1tality in the study. A procedure audit was conducted on January 8, 1988. Results were reported to the study director on January 8, 19112S.Results were reported to management on JanU3rv 20, 1988. A final inspectior,of all data and records on January &'0.1988 irdicatet-that E'.xreeport sub=ittee. to you is an accurate reflection of the studv as -@twas conducted by ABC
Laboratories.
Should you have any questions relating to the information provided
I 'n'fhi's tatement
or
the
function oa@o'ur
Qualitv
Lssurance Unit, please
contact the Quality Assurance Unit at your convenience.
Ij
Phillipi@$1B:uckler.
-Date.
Quality Assurance Supervisor.-
ABC LABS #36617-17 of 63
STUDY CO!TLIANCE STATEMENT
Study Compliance Statement for ABC report .#36617 entitled, "Acute Toxicity of E2566-2 to Fathead Minnow (Pimephales promelas)," for Mr. 1,-IohamedElnabarawy, 3M Company, St. Paul. 4irnesota.
In accordance with ABC Laboratories' intent that all aquatic toxicity tests conducted by our facility follow goed laboratory practices. ABC's study director for the above test herein confirms that the study was conducted in compliance with the OECD Principles of Good Laboratory Practice Annex 2, C(81), OECD Guldelines for Testing of Chemicals.
-. All original raw data were provided to 3,M Company, with a copy reia"i*n'ed'aAtnalytical Bio-Chemistrv Laboratories.
Tane E. Bou-man ABC Study Director
Date
l@:; ABC LABS #36617-18 of 63
Raw Data Report #36610'
Acute Toxicity of E2566-2 to Fathe--d Minnow (Pimephales promelas)
NOTE:
Some of the records which appear in this raw data appendix have
been provided as photocopies of original records or,file at ABC. This has been done by necessity for certain data which are used commonly in several 9-.udie-aat ABC. Such records include acclimation records, organism culture logs and well water
chemical screen results.
ABCL.ABS .
#.03.bb
I
pg.@ 0 1 qoioob3@