3M General orrices 3M Center d7 (2f 5 

St. Paul. MN 55144-le
651733 1110

06104.. K6 7e

   

September 24, 20(13, 53:; ff: f'j 

Bv Hang Delive?

Document Processing Center (7407)
Office of Pollution, Prevention and Toxics 5"
US. Environmental Protection Agency
1200 Avenue, N. W.
Washington, DC 20460

Attention: Section 8(a) Coordinator

Re: TSCA Section 8(9) Submissions 

Dear Sir/Madam:

3M Company requests that EPA place the attached studies in the
TSCA Section 8(e) docket. We have included a master index for these studies
identifying the study title, test substance and CAS number. A Confidential Business
Information (CBI) version of this index and the studies also is being submitted today
pursuant to EPA procedures. 3M has not provided CBI substantiation with this
submission, but would be willing to do so at the Agency?s request.

3M has concluded that data in these studies may not be, strictly speaking,
"corroborative" of previously reported or published information as defined in EPA's

reporting guidance or otherwise potentially may warrant 8(e) submission based on
reporting guidance.

3M appreciates attention to this matter. Please contact the

undersigned if you have any questions or require further information regarding this
submission.

Very truly yours,

(acme. rut W,

Dr. Katherine E. Reed, 

Staff Vice President

Environmental Technology and Safety
Services

(651) 778-4331



ZU =9 31.1.0 



Master Index to Studies Submitted Under TSCA 8(e) by 3M Company on September 24, 2004
(Confidential Business information Redacted)

  
 

Primary Irritation Study 
Rabbits 
20% solids (Ethomeen 1.0M with diethyl
sulfate 0.94M): 30% water [Ethomeen 3112 R-
Guinea Pig Contact Dermal where R=Cta with 1-2
irritatiordSensitization double bonds] 20% (61791?244) with 64-67-5); 80% 7732-18-5
Primary irritation Study -
Rabbits Butanoic acid. hepta?uoro. catcium salt 2366-98-5
Acute Oral Toxicity Screen with T-
2712006 in Albino Rabbits per?uorohexanoic acid 1307-24-4
Primary Skin Irritation Test with T-
2725Ec (Repeat Application) in
Albino Rabbits I 
Acute Ocular Irritation Test with T-
2725Ec in Albino Rabbits 1 1
Sensitization Study with T-2741AC
in Albino Guinea Pigs 1 I
Orai Range?nder Study of T-314OBS aniline amidel-Z
in Pregnant Rats potassium 3.4.5.6-tetrachiorophthalate 57589-852
80% t-B?iper?mmoctanesulfonate) anilino
amidel-Z-potassium 3.4.5.6-

Orai Rangefinder Study of T-313968 tetrachloropnthaiate; 5% homolog: 5% C5 80% 57589-852; 5% 68541-01-5 5% 68541-02?6;
in Pregpant Rats homoiog: 5% C4 homolog; 5% CB homolog 5% 68568?547; 5% 58815-72?5

Acute Oocutar irritation Test with T- acid diethanol
2997COC in Albino Rabbits amine salt salt of 133201-07?7 and 111-42-2
Sensitization Study with T-3386 in
Albino Guinea Pigs 1
Microbiological Mutagenicity
Assays of 3M Company?s .
Compound T-3411 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Master Index to Studies Submitted Under TSCA 8(e) by 3M Company on September 24, 2004
(Con?dential Business Information Redacted)

  
 

68% alpha-[2-

12% poiethytene glycol;
7% water: 4.86% 
alpha-[2-

4% residual organic
ftuorochemical; 3% heptadeca?uoro-i-
octanesulionic acid: 0.81% 
ethenediyl). aipha-[Z-

0.3% 1.4-dioxane; 0.2% n- 68% 29117-0845; 12% 25322-68-3; 7% 7732-18-5;
alcohol; 4.86% 56372-237; 4.05% 68298-793; 3.24%
Acute Oral Toxicity Screen with T- 0.03% linear n-ethyt 68298-814; 3% 1763?23-1; 0.81% 68298-80-6:
3448 in Albino Rats per?uorooclanesuifonamide 0.3% 123?91 0.2% 1691.99-2; 0.03% 4151-50-2
Microbiological Mutagenlcity
Assays 013M Company?s
Compound T-3516 
Acute Dermal Toxicity Study with T-
3451 in Aibino Rabbits Unknown
Acute Oral Toxicity - Method.
Summary. Pathology; Primary
Dermal Irritation - Method.
Summary; Primary irritation -
Method. Summam Guinea Pig
Maximization - Method. Summary 1 1
Acute Oral Toxicity - Method.
Summary. Pathology: Primary
Dermal Irritation - Method.
Summary. Primary Irritation 
Method. Summary; 1 

 

 

 

 

 

 

 

 

Dermal Sensitization Study in
Guinea Pigs. Maximization Test - .
Method. Summary i I

 

 

 

4 Hour Acute Aerosol Inhalation
Toxicity Study with T-3825 in Rats 1 1
Primary lrritaitonICorrosion
Study in Rabbits 
4-Hour Acute Aerosol Inhalation
Toxicity Study with T-3825 in Rats 1 1

 

 

 

 

 

 

 

Master Index to Studies Submitted Under TSCA 8(a) by 3M Company on September 24. 2004

  

?3820: Acute inhalation Toxicity
Test

 

(Con?dential Business Information Redacted)



 

T-3821: Acute Inhalation Toxicity
Test



 

T-3845 Acute Inhalation Toxicity
Test

chioride

 

Evaluation of the Acute inhalation
Toxicity oi T-3920 in the Rat

I

I

 

Primary Irritation Study in
Rabbits - Method, Summary

Decanoic acid. nonadeca?uoro, ammonium

salt

3108-42-7

 

Acute Oral Toxicity Study in Rats
(OECD Guidelines)

95% ammonium per?uorodecanoate; 5%

ammonium per?uorooctamate

5% 3825-26-1

 

Acute inhalation Toxicity Study with
114129 in the Rat

I

I

 

Acute Inhalation Toxicity Study with
T-4130 in the Rat

I



 

Acute Oral Toxicity Study in Rats;
Acute Dermal Irritation Study in
Rabbits; Acute irritation Study
in Rabbits

 

Denna! Sensitization Study in
Guinea Pigs_-Maximization Test

 

Mutagenicity Test on 4413{ 1
Mouse Fomard Mutation
Assay with Duplicate Cultures

 

Amie inhalation Toxicity Study with
T4354 in the Rat



 

Primary Dermal irritationlCorrosion
Study in Rabbits



 

Acute inhalation Toxicity Study in
the Rat with T4397

1

I

 

Primary trritattonICorrosion
Study of T-526?l in Rabbits

lithium telrafluoroethane-t .Z-disulfonimide

 

Acute inhalation Toxicity Evaluation
on T-5231 in Rats

I

I

 

41?Hour. Acute Inhalation Toxicity
Study with T-5305 in Rats





 

4-Hour. Acute inhalation Toxicity
Study (Limit Test) with 1153431 in
Rats

 

 

 

 

 

Master Index to Studies Submitted Under TSCA 8(e) by 3M Company on September 24, 2004
(Confidential Business information Redacted)

 

4?Hour, Acute Inhalation Toxicity
Study With T-5306 in Rats I 
4-Hour. Acute inhalation Toxicity
Study (Limit Test) with 15357.1 I 1 
Acute Dermal Toxicity Study of T-
4201 in Rabbits Lithium 90076-65?6
SubAcule 28-Day Oral Toxicity with
by Daily Gavage in the Rat
Followed by a 14 Day Recovery
Period I I I 
Subacute 28-Day Oral Toxicity with
T-2816 by 03in Garage in the Rat
Followed by 3 14-Day Recovery A
Period I I 1
Acute Inhalation Toxicity Evaluation
on T-5187 in Rats 
T4240 4-Week Oral Toxicity Study
in Rats 
Dermal Sensitization Study of T-
5473 in Guinea Pigs - Maximization
Test I I 1
4-Hour. Awte Inhalation Toxicity -
Study With T-5698 in Rats 
Awte Inhalation Toxicity Evaluation
0n T-5708 in Rats 
T-5486 Assessment of Cardiac 
Sensitization Potential in Dogs octatluoropropane 7649-?
Acute Inhalation Toxicity Evaluation
BET-5655 in Rats I I
T4201 4 Week Oral Toxicity Study
in Rats with 2-Week Recovery
Pen'od Lithium Bis?n?uoromethanesulfonyl?mide 90076-65?6

irritation to the Rabbit 1 I 1
Acute Inhalation Toxidty Evaluation
on T-5715 in Rats 1 1
Acute Inhalation Toxicity Evaluation
on T-5716 in Rats 1 1
Acute inhalation Toxicity Study of T-
5724 in Rats I - 1
Acute Inhalation Toxicity Study of T-
5725 (Resin Solution) in Rats 1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Master Index to Studies Submitted Under TSCA 8(a) by 3M Company on September 24. 2004
(Confidential Business Information Redacted)

 

Acute Inhalation Toxicity Study
(Limit Test) of T-5927 in Rats 
Acute lnhalation Toxicity Study of T-
5928 in Rats (LC50) 
Acute Inhalation Toxicity Evaluation
on in Rats 1 1
SingleDose Intravenous

Pharmacokinetic Study of T-5963 in
Rabbits 
Single-Dose Intravenous

Pharmacokinetic Study of in
Rabbits 1 1

 

 

 

 

 

87-93% fluorinated alkyl alkoxylales; 440%
linear Noethyl pertinerooctanesulfonamide; 2-
4% Wow? 

04% residual organic
fluorochemicals; 02% c8 sulfonamide: 0.14%
5-Daily Dose Dermal 1-heplanesulfonamide. N-ethyl?
Absorptionfl'oxicity Study of 87-93% 68958-61 440% 4151-50-2; 24%

and T-6032 in Rabbits miscellaneous components (each less than 68958-604; (Ii-2% 68957-62?0
Single-Dose Intravenous
Pharrnacokinetic Study of T-6061 in
Rabbits 1 
Single-Dose Intravenous
Pharmacokinetio Study of T-6065 in
Rabbits I 
Single Dose Intravenous
Pharmacokinetic Study of T6063 in
wait8 I I 1
Acute Inhalation Toxicity Study of T-
6235 in Rats 1
Primary Dermal lrritationICorrosion
Study of T-6402 in Rabbits I I 

 

 

 

 

 

 

Dermal Sensitization Study of T-

6402 in Guinea Pigs- Maximization
Test (EC Guidelines) I 
Acute lrritationlCorrosion Study 1?Butanesul?nic acid, 1,1.2.2.3.3.4,4,4?
with T-6318 in the Rabbit nona?uoro-. Sodium Salt 102061-826

 

 

 

 

 

 

Master Index to Studies Submitted Under TSCA 8(e) by 3M Company on September 24. 2004

  
  

  

Primary Skin Irritation I Corrosion
Study with T-6567 in the Rabbit (4-
Hour Semi-Occlusive Application)

(Confidential Business Information Redacted)


u?d

 

Assessment of Contact
Hypersenitivity to T?53?l 8 in the
Albino Guinea Pig (Maximization
Test)

1-Butanesul?nic acid. 1.1.2.2.3.3.4.4.4-
nona?uoro, Sodium Salt

1 02061 ~82-5

 

Singie?Dose Intravenous
Phannacokinetic Study of in
Rabbits

 

Singie?Dose Intravenous
Phannaookinetic Study of T-6504 in
Rabbits

 

Single Dose Intravenous
Pharmaookinetic Study of in
Rabbits

I 

 

A Study for Effect on Embryofoetal
Development of the Rat (inhalation
Administration)

20-80% methyl nonafluoroisobutyl other: 20-
80% methyt non?uorobutylether

20?80% 163702-084; 20-80% 163702-07-6

 

6695

Bacterial Reverse Mutation Test of 

1

I I

 

5-day Inhalation Toxicity of
Per?uorocyclohexene 1; T-
6878) in Rats

70% crude per?ucrocyclohexene; 30%


70% 3255-75-9

 

503in Dose Dermat
Absorptionfl?oxicity Study of T-6502
and T5503 in Rabbits



I 

 

Primary IrritationICorrosion
Study of T-6786 in Rabbits

Lithium 

1 32843-448

 

Primary Dermal trritationICorrosion
Study of T6804 in Rabbits

Lithium 

1 32843-4443

 

5-Day inhalation Toxicity Screen of
HFE 

1OCH3

4943-08-2

 

Primary IrritationICorrosion
Study of T-6804 in a Rabbit (OECD
Guidetines)

Lithium 

1 32 84344-8

 

Acute Oral Toxicity Study of T-6804
in Rats (OECD Guidelines)

Lithium 

1 32843-448

 

Dermal Sensitization Study of T-
6908 in Guinea Pigs, Mazimization
Test (EC Guidelines)

 

 

 

 

 

Master Index to Studies Submitted Under TSCA 8(e) by 3M Company on September 24, 2004
(Confidential Business Information Redacted)

       
 


3-H.
?Mt?

lr?tationiCorros" 5 sea; of T-
4127 in the Rabbit

 

tn - 

Fos Amiaer?pnen?w Phosphonium?

Chioride Complex; 0?1624

    

31506-32-8

 

Single-Dose Intravenous
Pharmaookinetic Study of T-6924 in
Rabbits

 

Dermal Sensitization Study of T-
6924 in Guinea Pigs- Maximization
Test (EC Guidelines)

 

Dermai Sensitization Study of 
7003 in Guinea Pm - Maximization
Test (EC Guidetines)



 

Report of Sara and Liver Data for 
Manoester - Preliminary ADME
Study in Rats

N-ethyl heptadecafluoro-Ntz-
octanesulfonamide
diammonium satt

67969-694

 

Diester-Phannacokinetic
Study in Rats (Study No. T-7043.1.
DT-26)

ammonium


30381-984

 

Single 0059 Intravenous
Pharmaookinetic Study with T4082
in Rabbits



 

Memester - Pharmaookinetic
Study in Rats (Study No. T439972)

N?ethyl heptadecafluoro-N[2-
(phosphonooxy)ethyl} octanesutfonamide
diammonium salt

67969-694

 

Determination of PFOS Presence
and in Serum from
the Dermai Absorption Studies of T-
7106 and T-7107 in 
Rabbits

 

Dermal Sensitization Study of T-
72855 in Guinea Pigs -
Maximization Test 
Guidelines)

 

TWenty-eight Day Repeated-Dose
Oral Toxicity Study of T6861 in
Rats

Lithium 

132843-44-8

 

Twenty?eight Day Repeated Dose
Oral Toxicity Study of T317005 in
Rats

 

 

 

 

 

 

Master Index to Studies Submitted Under TSCA 8(a) by 3M Company on September 24, 2004
(Confidential Business information Redacted)

 

Acute (4-Hour) tnhalation Toxicity oi
Test Atmospheres Obtained after
Heating{ 1 in Rats
Toxicokinetic Study of

in Rats per?uorooctanesulfonamido carboxytic acid 2806?24-8

I-1

9-1
Inn-l

 

 

Acute Nose-Only lnhaiation Toxicity
Study of T4087. T4088. T4089
and T-7090 in Rats (Limit Test)


u?a

Inn-J

 

 

Acute Ocutar irritation Study of 
7485 Applied to New Zealand White
Rabbits potassium nona?uorobutanesutfonate 29420-49-3
Toxicokinetic Study of
Per?uorooctane Suifonamide
T-7132.2) in Rats per?uorooctanesulfonamide 754~91~6
Acute Four-Hour inhalation Study in Per?urobutanesulionyt Ftuoride (96-98%) And
Rats Per?uorosutfotane 96-98% 375-72-4; 24% 42060?64?0
Primary lrritationICorrosion
Study of T-7508.2 in Rabbits 1 1 1
K-Satz; Test for Primary
Dermal irritation in the Rabbit 1
Assessment of Acute Oral Taxicity
with T4560 in The Rat (Acute Toxic
Ctass Method) 1
Acute lrritationlCorrosion Study
with T-7560 in the Rabbit 
1 Potassium bis-
(per?uorobutanesutlonyl)imide
Repeat Dose ADME Study in Rats Potassium 129135-874
Toxicity Study by Repeat Dose
Inhalation Administration to CD Rats Perlturobutanesulfonyt Ftuoride (96-98%) And -
for 4 Weeks Periiuorosutfotane 96-98% 375-72-4; 24% 42060644)

 

 

 

 

 

 

 

 

 

A Sub~acute( 28 Day) Inhalation
Toxicity Study, including a Recovery 
Study. in Rats pentanon 75643-8
Xenochemicat Receptor trans-

Activation by Perfluorooctane-based
Chemicals per?uorooctanesulfonamide 75441-6

 

 

 

 

 

 

 

Master Index to Studies Submitted Under TSCA 8(e) by 3M Company on September 24, 2004
(Confidential Business information Redacted)

 
 

. .. 
. 

 

84% 1?octanesuifonic acid.

heotadeca?uoro. potassium salt; 5.5%
potassium (per?uorohexyikultonate; 4%
potassium nona?uorobutanesulloriate: 4%
potassium per?uoroheptanesulfonate: 2%
potassium perituoropentanesullanate; 0.5% 84% 2795-39-3; 5.5% 3871-996: 4% 29420-49?3;
unknown 4% 60270-555; 2% 3872-25?1

95% 
alcohol; 5% 1-heptanesuifonamide N-elhyl-

(Z?hydroxyathyl} 95% 1691-99-2; 5% 68555-73??

 

 

Acute Inhalation Toxiookinetic Study
of Perftuoroctanesulfonyt Fluroide
(POSF) T-TOQBA per?uorooctanesulfonyt ?uoride 307-35-7
Five-Day inhalation Toxicity Study of
HFE 1 in Male CD Rats c-C?Ft 181214-67?5
Acute Toxicity Screen of
Perttuorocyctohexene in 70% crude pertiuorocyclohexene; 30%
Rats 70% 1355-75?9
(T-7056)
Toxicokinetic Study in Rats 
N-Methyl Pediuorobutylsulfonamide 95% 1?
Assessment of Acute Oral Toxicity Butanesulfonamide, 1.1.2,2.3.3.4.4,4?

with in the Rat (Acute Nona?uoro-mMethyt; 5% N-Methyl-4?Hydrido-
Toxic Class Method) Per?uorobutytsultonamide 68298-124
Subchronic 90?Day Oral Toxicity
Study with T-7320 By Daily Gavage
in the Rat Followed by 3 28-Day
Raceway Period 1 1

84% 1-octanesulfonic acid.
Protein Binding of Per?uorobutane 
Suttonate. Per?uorohexane heptadeca?uoro. potassium salt; 5.5%
Sultonate. Perftuorooctane Sultanate potassium 4%
and Pertiuorooctanoate to Plasma potassium nona?uorobutanesultonate; 4%
(Human. Rat. and Monkey), and potassium perftuoroheptanesulfonate; 2%
Various Human-Derived Plasma potassium perltuoropentanesulfanate; 0.5% 84% 2795-39-3; 5.5% 3871-99-6: 4% 29420-493;
Protein Fractions unknown 4% 60270-55?5; 2% 3872-25-1
potassium nonafluorobutanesulfonate 29420-49?3

tassium (pei?uorohexylpulionate 3871-99-6

 

 

 

 

 

 

 

 

 

 

 

 

 

Master index to Studies Submitted Under TSCA 8(e) by 3M Company on September 24. 2004
(Con?dential Business Information Redacted)

 

?potassium perftuorooctancate

2395-00-8

 
  

 

Five Day Inhaiation Toxicity Study of
Monochtoride. 1. and
in Male CD Rats

C4F9-OCH2CI

205367-42-6 (n?isomer) and 221617-86?3 (I-
isomer)

 

C-C6F1 

181214?67-5

 



507-554

 

Toxicokinetic Screen of I (Tr

7483) in Rats



89685-56-3

 

Low Level Oral
Per?uorooctanesuifonate (PFOS)
Dose Toxiookinetic Study in Rats:
Serum and Liver PFOS

 

84% twanesutfonic acid,

heptadeca?uorm potassium salt; 5.5%
potassium (per?uorohexyl)sutfonate: 4%
potassium nona?uorobutaneculfonate; 4%
potassium per?uoroheptanesutfonate; 2%
potassium per?uoropentanesutfanata; 0.5%

 

unknown

84% 2795?39-3: 5.5% 3871-99-6; 4% 29420?49?3;

 

 

4% 60270-555: 2% 3872-25-1

 

10

Experiment No.:

Conducted At:

Dates Conducted:

Conducted By:

Acute Oral Toxicity Screen

with 

in Albino Rats

0479AR0680

Safety Evaluation Laboratory
Riker Laboratories, Inc.,
St. Paul, Minnesota

December 7, 1979 to December 26, 1979

51.5% 

k. L: Ebbens, BS Date

Supervisor, Acute Toxicology
Study Director 


,r

Summary

An acute oral toxicity screen with was conducted from December
7, 1979 to December 26 1979 at Riker Laboratories, Inc., St. Paul, Minnesota
using male albino rats ranging in body weight from 159 tc 270 grams. The test
article was administered by gastric intubation at dosage levels of 5,000, 1,000
and 500 mg/kg body weight with mortalities of 5/5, 5/5 and 1/5 noted respectively.
The untoward behavioral reactions which occurred during the 14 day observation
period generally consisted of ataxia, emaciation, hypoactivity, sale
ivation, prostration, and unkempt appearance. The onset of the reaCtions oc?
curred from 1?30 minutes to 5 days post dose and all reactions subsided by day
5 or death precluded recovery. Body weight losses were noted for 3/4 animals
from the 500 mg/kg dose group which survived the 14 day test period. Gross ne?
cropsies performed at the end of the 14 day study generally revealed hemorrhagic
vas deferens and one incidence of atrophic testes. Chemical burns of the stomach
and intestines were generally noted in the animals which died acutely, however,
autolysis precluded gross tissue evaluation of two animals. The approximate
oral LDSO of is less than 1,000 mg/kg and greater than 500 mg/kg in
fasted male albino rats.
Introduction

The objective of this studyE-was to approximate the acute oral L050 of
Tu27l2CoC in fasted male albino rats. The study, which was initiated at Hiker
Laboratories, Inc., St. Paul, Minnesota on December 7, 1979 and completed on
December 26, 1979, was not conducted to support a government submission or
marketing permit, and is therefore not regulated by the Good Laboratory Practices
Act of 1978. The raw data generated by the Study Director and final report are

stored in the conducting laboratory's archives.

E'Riker Toxicity Experiment No.: 0479AR0680, Test Method 605A

Method and Results

 

Young albino.ratsE-were used in this test. All animals were held under
quarantine-for several days prior to testing with only animals which appeared
to be in good health and suitable as test animals at the initiation of the
study used. The rats were housed in suSpended. wire-mesh cages in temperature
and humidity controlled rooms and permitted a standard laboratory dietE-plus
water ad libitum except during the 16 20 hour period immediately prior to
gastric intubation when food was withheld.

The rats were administered the test article at pre?selected dosage
levels. All doses were administered directly into the stomachs of the
rats using a hypodermic syringe equipped with a ball-tipped intubating
'needleg. 

After gastric administration of the test article, the rats were returned
to their cages and observed for the following 14 days. Initial and final
body weights, mortalities (Table l) and adverse reactions (Table 2) were 
corded. A necropsy was conducted on all animals that died during the study
as well as those euthanatized at the end of the 14 day observation period
(Table The protocol, principle personnel involved in the study, composition

characteristics, and Quality Assurance statement are contained in Appendices

?-Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts
?-Ralston Purina Laboratory Chow, Ralston Purina, St. Louis, Missouri
E?Popper and Sons, Inc., New Hyde Park, New York

TABLE 1

ACUTE ORAL TOXICITY SCREEN ALBINO RATS

with T-2712COC

Mortality, Necropsy and Body Weight Data

 

Individual Body Weights 

 

Dose 1 Animal Test Day Number: Number Dead Percent
(mg/kg) Sex Number 0 14 Number Tested Dead
5,000 9R21177 - 179 (1 Hour) 5/5 100
9R21178 168 (2 Hours)
9R21179 180 (1-30 Minutes)
9R21180 178 (1 Hour)
9R21181 174 (1 Hour)
1,000 9R21184 183 (2 Days) 5/5 100
9R21185 181 (3 Days)
9R21186 167 (2 Days)
9R21187 191 (6 Days)
9R21188. 159 (2 Days)
500 9R20680 247 (5 Days) 1/5 20
9R20681 243 186
9R20682 250 171
9R20683 254 289
9R20684 270 205

 

Note: Figures in paretheses indicate time of death
The approximate acute oral L050 is less than 1000 mg/kg and greater than 500 mg/kg in
fasted'male mice.

a . . . .
"'The test article was administered undiluted

Necropsy Findings:

Necropsy of the animals which died acutely generally revealed chemical burns of the
stomach and intestines, however, autolysis precluded gross tissue evaluation of two
animals. Necropsy of the animals which survived the 14 day observation period re?
vealed an atrophic testicle and hemorrhagic vas deferens 

 

TABLE 2
ACUTE ORAL TOXICITY, SCREEN ALBINO mes
- with T-2712COC

Swat-y of Reactions

 

Time of Onset, 3
Dose Number Affected Following Dose

(mg/kg) Sex Reaction Administration

Cessation of Reaction 
Following Dose
Administration

Time Death
Following Dose

 

Number Dosed

5,000

1.000

ml

oi

500


Hypoactivity
Salivation


Emaciation
Hypoactivity
Prostration
Salivation
Unkempt
Appearance

Ataxia

Hypoactivity
Mucous in
mouth
Salivation
Unkempt
Appearance
Vocalization

4Hour
1?30 Minutes
1-30 Minutes

1?30 Minutes
4 Days?
1?30 Minutes
5 Days
1-30 Minutes
4 Days?

1 Day

1?30 Minutes
1 Day

3 Days

1?30 Minutes
3 Days

1 Day

Time indicates when no animal in the dose group exhibits the reaction.

Until Death
Until Death
Until Death

2 Days
Until Death
5 Days
Until Death
1 Day
Until Death

3 Days

Until Death
Until Death
Until Death

1 Day
Until Death

2 Days

Time indicates when first animal in the dose group exhibits the reaction.

1?30 Minutes?2 Hours

2 6 Days

S_Days

Riker ExPeriment NO..: Oq jq? Rab? 

 

 

 

 

APPENDIX I
. PROTOCOL
. 5.
TEST: 14ch 7011(1?? .
SPONSOR: 3M Cdnpany {imam/1? 

CONDUCTED BY: Safety Evaluation Laboratory, Riker Laboratories, Inc., st, Paul, Minnesoi

TEST ARTICLE: 13.33??- 
(IDNTROL ARTICLE: 

 

paeposeo DATE or TEST: hr;- -- 313rss'r system AND SOURCE. hwy, ?up? 
Saint 0?
Number: 

Weight Range: (50' 333

 

OBJECTIVE: The objective of this test will be to characterize the acute
(ytigkis toricity of the test article in albino
?lo?t? . {305( were selected as a test system
.for reproducibility of response, historical use. ease in handling
and general availability.

 

 

METHOD: The animals will be housed in stainless steel suspended wire mesh
cages in temperature and humidity controlled rooms during both the
quarantine and test periods, with food?~and water offered ad
libitum?._ Each animal will be identified by color coding, accord-
ing to the laboratory's standard Operating procedure, which will
correspond to a card affixed to the outside of the cage. A single
dosage of 5000 nag/kg will be administered to each animal. The
test articleiwill be administered to the animals in the form re-
ceived from the sponsor, after which the animals will be return 
to their cages and observed for any untoward behavioral reactio 
for the following 14 days. Initial and final body weights wil ?be
recorded. gross necropsy which will include, but not be lim ted
to; heart, lungs, liver, kidneys and general gastrointestinalrtract
will be conducted on all animals which die during the conduct of
the test as well as the animals surviving the test period. Any
gross abnormalities which are observed during the conduct of the
'necr0psy will be recorded with specific mention to the organ and/or
site observed. All raw data and the final report will be stored in
the Biker Laboratories Archives, St. Paul, Minnesota.

a . . . .
?-Purina Laboratory Chow, Ralston Purina. St. Louis, Missouri

dip. -.5. 
W) u? . ?tL241.211, Law/M 54M 44/1211? 

Sponsor Date. Studyl Direct?or' Date

.u .. 

 

1.

Miter Exocrinent NO. 

APPENDIX I(concluded)
Amendment to Protocol


 

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Twila; 1? :15? 2Q. Brr?uLYJk L- 

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121745-22 m. gjg/ 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Study Director Date

2.
Study Director Date

3.
Study Director Date

4.
Study Director Date

5.
Study Director Date

6.
Study Director Date

7.
Study Director Date

a.
Study Director Date

 

APPENDIX II

Principle Participating Personnel Involved in the Study

Name

.K. L. Ebbens, BS

x. D. o'Malley, as

J. A. Skroms

G. C. Pecore

 

Supervisor, Acute Toxicology
Study Director

Advanced Toxicologist
Technical Writer

Acute Toxicology
-Senior Laboratory Technician

Coordinator
Animal Laboratory

APPENDI I I I

ComEosition Characteristics

 

This study is not regulated by the Good Laboratory Practice Act of 1978
and therefore information pertaining to composition characteristics is not

applicable for inclusion in this study.

APPENDIX IV

Quality Assurance Statement

This study is not regulated by the Good Laboratory Practice Act of 1978
and-therefore a statement signed and prepared by the Quality Assurance
group is not applicable,r This study was, however, audited by the Quality
Assurance group.

In addition to the data audit, different significant phases for studies
underway in the Biocompatibility Laboratory are inspected weekly on a
recurring cycle, and the facilities are examined by Laboratory Quality-

Assurance on a three month schedule.