111111111111111111111111111111111111111111111111111111111111 • 

OTS0200466 N 

One Source. One Search. One Solution. 

ACUTE TOXICITY STUDIES IN RABBITS AND RATS 

WITH RESIDUE OF HEXABROMOCYCLODODECANE 

WITH ATTACHMENTS AND COVER LETTER DATED 

030178 

14 FEB 1978 

U.S. Department of Commerce 

National Technical Information Service 

CODING FORM FOR SRC INDEXING REVISED 10/15/86 

0TS0200466 

ACUTE TOXICITY STUDIES IN RABBITS AND RATS WITH RESIDUE OF 

HEXABROMOCVCLODODECANE WITH ATTACHMENTS AND COVER LETTER 

DATED 030178 

RESIDUE OF HEXA3RDMOCVCLDDDDECRNE 
r ·- i~-r~~-~~;~~~0;1/-.- · -:~; \ ' 

VELBICDL CHEMICAL CDRPDRATIDN 

:341 EAST 0H1o STREEIT • CHICAGO, ILuNo!S 6061, • :312~670~4!500 . ' 

Director of the Office of 

Toxic substances (WH-557) 

• u. s. Envirorunental Protection Agency 

401 M Street, s.w .. Washington, o.c. 2Q460 

Re: Residue from 

Dear Sir: 

hexabromocyclododecane 

) 1'<'+ 

The attached document· is submitted' for your files and in 

compliance with TSCA section 8(e) if the latter is necessary. 

In summary, the document reports the result of a toxicology· 

study. 

For the record, the document is identified as follows: 

"Acute Toxicity Studies in Rabbits and Rats", IRDC #163-

500, February 14, 1978. 

We make no judgment that this document contains information 

concerning a substantial risk. We reserve our right to contest 

the propriety of TSCA section 8(e). 

TRL:eh 

Enclosure 

Sincerely, 

V~=IC;z~OZTION 

Lrnas R. Loy - / 

Manager, 

Regulatory Activities 

Environmental sciences and 

Regulatory Activities 

= 

0 

0 

01 

[J 
' '",.·~~·.~-e 

,, - 11'· 

"I 

lnleuu/tiona! Research and DeveiOplli,:::i. Corpc;ration ·-··---··---- --,..-'-:-'~ 

SPONSOR: 

TEST }!ATERIAL: 

S!JB.JECT: 

Vel.sicol Chemir..E~l Corporat?.on 

FM 100 Residue 

~e Toxicity Studies in 

Rabbits and Rats. 

}

nP. 

t.or 

Sp 

i 

' 

co· 

Approved by: D. Clifford Jessup, Ph.D. 

Associate Director of Research 

/V~~rq...t....c!,4t. * ~ x.s~ ?.1:. ' ' . . . ·. '. :: ~ ., ' ' ' . ' ' ... · 

., 

163-500 :;·, ;·': ... ' '' .; :·' .. •. ,(.·!·. \;;;;·.'.- . :~ >~·:}::·L~!~J 
., 

~1" 

" .. 

. ! ~ 

I' ! 

' 

I~ Synopsis • • • 

II.. Test !·fate rial 

III. Primary Eye Irritation Study in the Albino Rabbit 

A. 'Hethod • 

B~ Results 

.. 

IV. Primary Skin Irritation Study in the Albino Rabbit 

A. Hethod • 

B. Results 

V. Acute Dermal Toxicity Study in the Albino Rabbit 

A. Hethod • 

B... Results 

1. Hortality and LD50 Values 

2. Body lleights • , • 

VI. Acute Oral Toxicity (LD50) Study in Rats 

A. Hethod • 

B~ Results 

1. Hortality and Ln50 Values 

2. Body lleights • . • • . • . 

Table }!o. 

1. Pri~Ary Ey~ Irritation - Group Obsarvations 

2u Primary Eye Irritation ~ Group Average Scores 

3. PrimarJ Eye Irritation - Individual Rabbit Scores 

4. Primary Skin Ir:r·itation - Individual Rabbit Scores and 

Score Calculation • • • • • .. • • • • • 

163-500 

. 

Page 

1 

2 

3 

3 

5 

15 

15 

15 

19 

19 

20 

20 

21 

22 

22 

23 

23 

24 

7 

8 

9-14 

18 

I} 

Ql 

~ 
.. • 1·' . 

. r 

i' 

' . -··-·- -· ·--·· 

I. 

...... ---··· .. --.-, .... ···---·. ·--·-···-·-

SYNOPSIS 

Primary Eye Irritation Study in the. Albino.:,;·Rabbit 

A pri~ry eye irritant~ 

Primary Skin Irritation Study in the Albino Rabbit 

Primary Irritation Score = 2.2 

Not a Frimary skin irritaUt or a co~rosiVe material. 

Acute Dermal Toxicitv (LD50) Study in the Albino Rabbit 

Male Rabbits: 3536 (1768 - 7071) mg/kg. 

Female Rabb}ts: 5000 (1250 - 20000) mg/kg. 

Page l · 

Combined Hale and Female Rabbits: 3969 (2916 - 5400) mg/kg. 

Acute Oral Toxicity (Ln50) Study in Rats 

Hale Rats: .1258 (926 - 1711) mg/kg. 

Female Rats: 680 (535 - 864) mg/kg. 

Combined Hale and Female Rats: 924 (719 - 1188) mg/kg. 

'• 

163-500 
1ii-'7Cf ei70~1 ,_.,. 

. . .v 

International Research cmd Devclupiltc 

II. TEST HATERIAL 

The test material 'HaS received from the Velsica~ Chemical Corporation, Chicago, Illinois as follows: • . Test 1-!aterial Identification .Physical Description Date of Receipt 

Til too Re~idue 

Flammable Liquid NOS 

ATTN: C. Calo, #3322 

Til 100 Residue 

163-500 

77.901 

.!l:ro!m .. ~ql'!<L'!~\:lL ..... , . -~. 

'off-white residue ··JiiiY ~~·~, ~977 

at bottom · '

1 

Very dark redbrmm liquid August 12, 1977 
' , 

r 

1 

1 .. 

I

! 

CV'f6"' 7~~ff'f! " 

III. 

ltzternational Research t:1.':.i ·D,;·:•f/lopnw;;t CoFporatio11 ·---·· ·-· ·-··••"•-.----·-·-- ---- ;_,... _________ _ 

l:'RDL\RY EYE IRRITATION SIUDY IN THE ALBINO RABBIT 

A. M!':THOD: 

Fage 3 

Three male and 3 female New Zealand White rabbits (obtaine~ froffi 

Sweetwater Farms, Hillsboro, Ohio) were used for this Study. The rab-

' 

bits weighed, from 2510 to 3305 grams at the beginning of the study. 

The rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlied quarters. They wel:e maintained in ac"": 

cordance with the recommendations contained in H.E.W. Publication No. 

74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory 

Animals". Water and Purina Rabbit~: Chotv were available ~ libitum. 

Prior to test material ad~nistration, the eyes of each rabbit 

were examined with ultraviolet light following instillation of one drop 

of~ 2.0 percent sodium fluorescein solution. Rabbits' exhibiting corneal lesions were discarded. 

The rabbits received 0.1 milliliter of the test material. The test 

material was place·l into the cupped conjunctival sac of the right eye of ., ' 

each rabbit following which the eyelids '<ere gently held together for 

one second. The left eye serve4 as the untreated control for each.rabbit. None of the rabbits received a washout. 

The treated eyes were examined in accordance with the following 

schedule: 

24 hours following instillation 

48 hoiirs 

72 hours* 

7 days* 

14 days* 

*Sodium fluorescein examinations were conducted at these intervals. 

After .. grading the eye reaction, one drop of sodium fluorescein was i!=lstill.ed directly onto the corneal surface ~f each 1:~bbiL After a few 

·:,. secorids, excess s~ain was flushed frqm the corneal surface wit:h distilled 

water and the eyes examined 't~ith ultraviolet light:. ·< .~~ 

The grading system emploYed in this test P'rocedllre ~s .pres~n~ed Or: 

page 4. 

163-500 
•.. 

I 

: (1) Co !:nee 

(A) Op.:..c:i.ty~egr.::.e of densit:y (B:rea most d.:an:Se caken for reading) 

(B) 

Score 

~io op3.c.ity . • • . • . • . • . . . • • • . . . • • , • • • • • 

Scattered or diffUse ~rea, de.~ails of iris clearly visibl8 .- . 

Easily d~sce.rnible t:-ansl!J.c.enl: areas, det:ailS o£ i!:is slightly 

obscured • ~ • • • • • • • . • ·• .; • • • ~· • • • • . • . • 

Opalescent areas. no details of iris vis~ble. size of pupil 

barely discernible • • 

Opaque, i.ris invisible • • •. 

~~ea of cornea involved 

One quarter (or· less) but not zero· •.. 

Greater than one quarter, but less- than hal£ 

Greater than half; bUt less than . three quarters. 

Greater than three quarters, up to whole area. , equals A x B x 5 

3 

4 

1 

2 

3 

4 

Total maximum = 80 

(2) Iris 

(3) 

(A) Values 

Not'!i}al • .. • .. • • .. • • • • • • • • • • • • • • • • • • • • • • 

Folds above normal, congestion, swelling, circumcorneal injeCtion 

(any or . __ all of these pr combination of any thereof) iris still 

reacting to light (sluggish reaction is positive) •• ~ ••. ~ 

No reaction to light, hemorrhage, gross: destruction (any or all 

of these) • • • • • • · • • • • • • • • • • • . . • • • • 

0 

1 

•, 2 

Score equals A X 5 To tal maximum. , ·1 0 

Conjunctivae 

(A) Redness (refe~s to palpebral and bulbar conjurictivae exl~din~ 

cornea and iris) 

(B) 

Score 

Vessels normal • .. • • • • • • • • • • • • • • • Vessels definitely injected abOve normal •••••• 

MOre diffuSe, deeper crimson red, individcal vessels not easily 

discernib1a 

Diffuse be~fy red. 

Chemosis 

No ·swell"inz. " • • 

Any s-welling above normal (includes nic.tif:ating metabr~e). 

Obvious s~elling -with partial ever3ion of lids • • • • • • 

Swelling with -·lids about half closed • • • • • • • • • • • 

Swelling wich lids about half closed to c.ocpletely closed. 

Discharge 

No discharge • • • • • • • • • • • • • • u • • • ~ 

Any amount different from normal (does not include small amounts 

observed in inner canthus of normal animals) • • 0 

;.Discharge Yith <r.:oisten:i.nz '0£ the lids and hairs just adjacent 

to the lids~ • • • . • • . • • • • • • • • •' • • • • • .. • 

Discharge with moistening of the lids and hairs, and considerable 

0 

l 

2 

3 

0 

1 

2 

3 

4 

0 

1 

2 

area a-round the eye. • .. • • • • • • • • • • 

equals (A + B + C) x 2 

•. 3 

TO tal oa:dtil.um "' 20 

The maximum total score 

iris, and· conju:ncti.vae .. 

is the! sunf of .ill scores obtained f'ot: 

Tot-al me:d;::u!m sCo!'c ·po$sibl!! = 1~~-

the cut:nea, 

,, 
~-· ' 

~-· _._f ______ l'-.ntcrnatiotwl Rese._:r:(I __ a_n_a_'_D_~::,eioplll!'";i' f.}oJpora[~:~~--·~---~ 

I 

I 

·page 5 

B. RESULTS: 

Table 1 pred~nts the grade of effect with time. Table 2 shows the 

group average scores. Table 3 presents the· individual rabbit scores. 

· Based upon the data, the ·test material :J would be consideied a primaiy.eye irritant. 

The test material would be furth~r classified, based upon ~h~ scores 

obtained, ~S: being 'extremely irritating to the eye when evalua~ed using 

the method described on page 6. 

163-500. 

. ;,;.·.· 

'c¥ . ~ 

~.· 
,·:. - .. 

· ~: · '% ~ ~· ':Jcoo6ofi!,. " ._ .. =,'' _____ ._· .-.····-. " 0 '--.::.S.:;,~----=-:..-· .... ~- ci 'Jest :·!::':e:.:.-::.e.ls 

}! ~>El:asB.d en. :::·y:;. !.=r=it:=.ti~n1 ?::cp:.:::t:..es 

Page. 6 

• 

~on·-J::::::.:!.tati.ng 

-or~ ct..; C::lll-.r 

-N~n-Ir±;itB.ting 

l-'f..in,i.titally 

:Crz:oitatinq 

1'-ildl.y 

.Irri ta.ting· 

Hod.e~at~;y 

Irr.:!-taL:.l.ng 

Severely 

:r:::::ita.ting 

E:"tr:::e ly 

rr=i tat.i...~S' 

163-500 

··:'·· 

:Ra.:1cs: 

0.0 - 0.5 

G.re.a ter t:ha..."'l 

0.5 - 2.5 

Greater than 

2.5 - 1.5.0 

Greater than 

15.0 - 25.0 

Greater t..l;.a..'l 

25.0 - so.o 

Greater than 

50.0 - so.o 

Greater t..~an 

so.o - 110.0 

..., 

oe::i::ition 

mo m"a4-~~~~ ~~~s r-~1.·-c: ~j~ r- ..:. ! -:-""'"''--.... --. '---:"':" 7 :::.,_ .:.~ .. , -::"'- ~C'-'.l..~S 

at t..:.'"le .. 24-hcur reading ·must be zero; 

otller,.;ise r .tncrease ratirit; one .level .. 

To maintain ~~is ratina 1 all scores 

at the 24-hour rcaC.i:ig-~ust be ze::-o; o~~er~ise, increase ~at~ng one ~=vel. 

To 'maintain this rating, all scores 

at the 72~gour·reading must be zero; 

OtherNiSe 1 increase rati~g one lCVel.;, 

To maintain this rating 1 ~11 scores 

at the 7-day reading must be zero; 

otherwise, increa-?e rating one 

level. 

TO maintain t.;.is rating, scores ·at 

7 days must be less than or ecual 

to 10 for 60% or more of t..l;.e • 

animals. Also, ~ean 7~dav score 

must be less than or ecuai to 20. 

I:E 7-d,:p.y m~a..'"'l. score is -less than or ec:~al to 20 but less then 60% of a~imals shew scores less than lO, the~ no animal ~~onq L~ose showing 

scores greater than lO can exceed a 

score of 30 if rating is to be 

maintained; o~~e~Nise, inc~ease 

rating one level. 

To rn~i~tain ~~is ratirig, scor=s at 

7 davs rilu.St Ce li:ass than or ec;:ua~. 

to ·30 fOr 60% or more of the animals. 

Also, mean 7-day score must be·leSs th~, or equal to 40. ·If 7-day mean 

score ~s less t..~an or equal to 40 

but less than 60% of the animals· 

show'scores lass ~~an or ecual to 

3Q, then no animal a~ong those 

shewing scores greate: ~~an 30 c~~ 

exceed a score of 60 i·f ::atin'? i_s 

to .be mai.ntai~ed. 1 oth.erN"isaz :l::.-

c.re.a.se _rat-! ng one··ll?vel.. Ji 
• . 

' 

. 

.. 

.. , . 

' . '6"3 -'f;g c:60'B'& .. ·. ~ ., 

• '<. Page 7 .t.:'H•lOO Residue: EYe Irritation in the Albino Rabbit; ··.;_ 

I/.BI.:S l. Group .Obsarval:iOris 

.;,,:·-··~ .. E:.;arninat ion InCe:-:re.l --:-l?'"·'-·!'i (:-lo·, Positive/No .. · DaseCO. 

Observation 

Cornea: Cornea Nor:na.l 

Dulling nol:mal corneal lusr:er 

Corneal opacity: 

Iris: Iris Normal 

Iridal I~ritation 

Conjunctivae: Redness: 

Chemosis: 

Discharge; 

Sodiu."ll Fluorescein/ Negative: 

Ultraviolet lieht (normal) examination: 

~: 

Positive: 

(corneal ini ury) 

Corneal Epithelial Damage, Peeling 

Blanching, Conjunctivae 

Petite Hemorrhaging, Conjunctivae 

Vascularizations of Corneal Surface 

Pannus 

very slight 

slight 

moderate 

marked 

normal 

very' slight 

slight 

moderate 

mark.ed 

normal 

very slight 

slight 

moderate 

marked 

normal 

very slight 

slight: 

moderate 

marked 

Purulent Discharge 

Conjunctival Tissue Extending over cOrneal 

Surface 

163-500 

,, 

24 

6/6 

6/6 

4/6 

2/6 

1/6 

' 3/6 

2/6 

1/6 

3/6 

2/6 

6/6 

5/6 

2/6 

• 6(6' 

Hours 'Q.::!.~r:. . 

48 72 7 14 

l/6 1/6 2/6 

6/6 2/6 4/6 2/6 

3/6 1/6 2/6 

6/6 6/6 6/6 6/6 

1/6 

3/6 l/6 4/6 5/6 

3/6 5/6 2/6 

4/6 

1/6 .!/6 5/6 )/6 5/6 3.'6 1/6 1/6 

2/6 

2/6 

1/6 2/6 1/6 

6/6 3/6 3/6 2/6 

2/6 1/6 l/6 

0/6 0/6 0/6 

6/6 6/6 6/6 

6/6 6/6 5/6 4/6 

5/6 5/6 5/6 6/6 

2/6 2/6 2/6 4/6 

~/6 6/6 

.4/6 0/6 

6/6 . :6/6 <6/6' 416 •' 

. ; If, 

;.·: . 

, .. ' ' 

4 

"' 
'' ; <(-t-77f0007f'3' P~ge :a- ., 

_. 

.. 

F.> I 100 Residue: Ey~ IrriCatiOn ia the :Albi:10 ~Obit. 

TABLE 2 .. Group A.v~r::!gc Scar as. -

Average Sco-::es · (Rantte) ~;_~:· 

~ Period '101' 

H. ours ·Davs -~- Area 24 48 72 7 14 ~-

Cornea A 3.0 3.0 3.3 3.0 3.0 

(3. 0) (3.0) (2.0-4.0) (2.0-4.0) (2.0-4.0) 

B 1.8 2.3 2.7 3.0 1.8 

(1.0-3.0) (1.0-3.0) (1.0-4.0) (2.0-4.0) (1.0-3.0) 

Score 27.0 34.5 44.6 45.0 27.0 

Iris A 1.3 1.3 1.7 1.8 1.3 

(1.0-2.0 (1.0-2.0) (1.0-2.0) (1.0-2.0) (1.0-2.0) 

Score 6.5 6.5 8.5 9.0 6.5 ·~ 

Conjunctivae A 1.7 1.8 2.0 1.7 1.0 

(1.5-2.0) (1.5-2.0) (l.0-2.5) (1.0-2.5) (0.5-1.5) 

B 3 .. 4 2.9 3.3 2.4 1.5 

(2.5-4.0) (2.5-3.0) (2.5-4.0) (2. 0-3. 0} (0.5-3.0) 

c 2.3 2.1 2.3 1.9 1.3 

(1.5-3.0) (2.0-2.5) (1.0-3.0) (l. 0-3. 0) (0-3.0) 

Score 14;8 13.6 15.2 12.0 7.6 

Total Score 48.3 54.6 68.3 66.0 41.1 

163-500 
"6%- '?TfdCOi'v 

:Efl -l~O· .. t-~sidu~: 

Opacity (A) 

Area (B) 

Subtotal (A X B X 5) 

Irritation (A) 

Subtotal t:• (A X 5) 

Conjunctivae: Redness (A) 

Chemosis (B) 

Discharge (C) 

Subtotal (A+ B + C)x2 

Total Score: 

Sodiu~ Fluorescain ~~am: 

Per~ene Corneal Surface Pos~tive: 

Other: 

Corneal Epithelial Damage, Peeling 

Purulent Discharge Blanching, Conjunctivae 

Vascularzation of Corneal Surfa~e 

Pannus 

163-500 

Rabbit ~u.r..b~r 28656, ·Fe.rnaie 

Obs e.r·.rati·.:-r:s 

24 

3.0 

3.0 

45.0 

1.0 

5.0 

1.5 

3.5 

1.5 

13.0 

63.0 

X 

X 

X 

Hcours 

~8 

3.0 

3.0 

45.0 

1.0 

5.0 

1.5 

3.0 

2.0 

13.0 

63.0 

X 

X 

X 

Davs 

i2 1.4 

3.0 3.0 3.0 

4.0 2.0 !.0 

60.0 20.0 15.0 

2.0 2.0 1.0 

10.0 IQ.O 5.0 

1.0 1.0 0.5 

3.0 2.0 1.0 

1.0 1.0 0 

!0.0 8.0 3.0 

80.0 38.0 23.0 

Postive Positive Positive 

!00% 100% 100% 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 
,. ·.. ~~-cjl~~~-r. ~I ~00 ,~esidtia·: E;.~e l;rt'it~tion 

·.: i 

·...:: 

In~·ividu.al. Re.bbit. ~cOres. 

Rabbi;: ~:u!!:bo:r 28559. !>Lale 

Oils s:-·.-.:;, ;:i~n= '•'.' ::0t.:::'S \',. •. D~p:·s e:, Are .:a 24 !...S ;z 7 l~ ·.c, ,, ,.... 

Cornii!':a: Opacity (A) 3.0 3.0 4.0 4.0 3.0 p 

Area (B) 1.0 2.0 1.0 2.0 1.0 

f( 

Subtotal (A x B x 5) 15.0 30.0 20.0 40.0 15.0 

.I::is: Irritation (A) 1.0 1.0 1.0 2.0 2.0 

Subtotal (A X 5) 5.0 s.o 5.0 10.0 10.0 

Conjunctivas: Redness (A) 1.5 2.0 2.0 1.5 1.0 

Chemosis (B) 2.5 2.5 2.5 2.5 o.s 

Discharge (C) 2.0 2.0 2.0' 2.0 0 

Subtotal (A+ B + C)x2 12.0 13 .. 0 i3.0 12.0 3.0 

Tota~ Score: 32.0 48.0 38.0 62.0 28.0 

Sodiuc Fluorescein ~<am: Positive Positive Positive 

Percent Corneal Surface Positive: 95% 60% 5% 

Other: , Corneal Epithelial Damage, Peeling X X X X X 

Purulent Discharge X X x X 

Blanching, Conjunctivae X: X X X X 

Vascularization of Corneal Surface X 

Petite Hemorrhaging, Conjunctivae X X X X X 

!63-500 
1f '6- / lfdi:70 'ff''"l. 

n-t 16o' ·n~~idu2: Ey~ Ir'iit.e.tj,_cm in ·cpe Alb triO Rabbi·t. ·pag~ ll 

r;.Su: 3! .(Cont.) Individual Rabbi;t Scbres 

Rabbi I: :{urnb er ?8665. :O.fa]e 

Obsexv.:; tic-;:.s 

Hr.>l~'t'S DJJ·,·s 

Area 24 48 "' '- ; 14 

Opacity (A) 3.0 3.0 3.0 3.0 1.0 

Area (B) 2.0 3.0 4.0 3.0 3.0 

~ 

Subtotal (A " B X 5) 30.0 45.0 60.0 45.0 30.0 

~: Irritation (A) 2.0 2.0 2.0 2.0 1.0 

Subtotal (A X 5) 10.0 10.0 10.0 10.0 5.0 

Conjunctivae: Redness (A) 1.5 1.5 2.0 1.5 1.0 

Chemosis (B) 3.0 3.0 3.0 1.0 1.0 

Discharge (C) 2.0 2.0 2.5 2.0 2 •. 0 

Subtotal (A+ B + C)x1 13.0 13.0 IS .0 11.0 8.0 

Total Score: 53.0 68.0 85.0 66.0 43.0 

Sodium Fluorescein E..~am: Positive Positive Positive 

Percent Corneal Surface Posieive: 1007. 30% <5% 

~: 

Corneal Epithelial Damage, Feeling X X X X X 

Purulent Discharge X X X X X 

Blatiching, Conjunctivae X 

Vascularization of Corrieal Surface X 

Pannus X 

Petite Hemorrhaging, Conjunctivae X 

Conjunctival Tissue Extending over 

,Corneal Surface X 

1&3-500 
• F;·t .lUO .~~asidue: 1'V-78~~· Eye Ir!;'!.t.atiori i~ !:he Aibtno ·Rabbit:. ·- ·.· 

··r~\BlS: 31 (Cont.) 

Rabbit .Nuober 28672, Fe'male 

1)bs.:r-:e ticcs 

24 iZ i 

Opacity (A) 3.0 3.0 4.0 3.0 

Area (B) . 3.0 3.0 2.0 4.0 

Subtotal (A X B X 5) 45.0 45.0 40.0 60.0 

Irritation (A) 2.0 2.0 2.0 2.0 

Subtotal (A X 5) 10.0 10.0 10.0 10.0 

Coni unctivae: Redness (A) 2.0 2.0 2.5 2.5 

Chemosis (B) 3.5 3.0 4.0 2.5 

Discharge (9) 3.0 2.5 3.0 3.0 

Subtotal (A+ B + C)x2 19.0 17.0 19.0 16.0 

Total Score: 74.0 72.0 69.1) 86.0 

Sodium Fluo~escein Ex~: Positive Positive 

Percenc Corneal_Surface Positi~e; 100% 85% 

Other: 

Corneal Epithelial Damage, Peeling X X X X 

Purulent Discharge X X X X 

Blanching, ConjunC:ti·vae X X X X 

Petite Hemot·rbaging, Conjunctivae 

PannUs X 

Vascularization of Corneal Surface 

163-500 

4.0 

1.0 

20.0 

2.0 

10.0 

1.0 

1.5 

3.0 

ll.O 

41.0 

Positive 

<4% 

X 

X 

X 

X 
. . ·15~~/~ZJ$ Ff!. '!?o·.~~si.d~ie: .·Eye tr·:ritiltioo in t~e.Albino Rabbit. .Pege 13 ~ 

TA3LE J. (Cont.) Individual Rabbit SC~res 

Rabbit: ~umber 28ii7s·, Hale 

Obsar-mt:ions. 

?.C)U"!:S Da;.·s 

2~ ·t..s i2 .. &-. 7 14 

Opac.ity (A) 3.0 3.0 4.0. 3.0 2.0 . .. ~· 

Area 

Area (B) "1.0 2.0 1.0 3.0 3.0 

subtotal (A X B " 5) 15.0 30.0 20.0 45.0 30.0 

Iris: Irritation (A) 1.0 1.0 2.0 1.0 1.0 

Subtotal (A X 5) 5.0 s.o 10.0 5.0 5.0 

Conjunctivae: Redness (A) 2.0 2.0 2.5 2.0 1.0 

Chemosis (B) 4.0 3.0 4.0 3.0 2.0 

Discharge (C) 3.0 2.0 3.0 2.5 1.0 

Subtotal (A + B + C)x2 18.0 14.0 19.0 15.0 8.0 

Total Score: 38.0 49.0 49.0 65.0 43.0 

Sodium Fluorescein Exern: Positive Positive Positive 

Percent Corneal Surface Posi·t:ive: 100% 20% <5(;: 

~= 

Corneal Epithelial Damage, Peeli.ng X X X 

Blanching, 

Purulent Discharge X X X X X 

Vascularization 

Conjunctivae X X X X X 

of the Corneal Surface X X 

!6 3-500 
. ' ff(J'c."?o~·<fi' f?! lO'o. R€Sidue: E::,.·_e t·'!;-:rit_.atiOft ir! th~ Albi.;:o- Rab6i:2"! : . Piige -14 '· ., ' - . \... . 

·rAn::::." J,. (Cont.) Individual R~b-bit Sco'i"es 

Ri:!.bOii: Ntif:l:Jcr 2869t.. Female . Ob~;n·.:u:ions ~c E~~ci-s .. Da..-s " ···~· .-traa ? • !.3 72 1 '\;,'' :;_.a -" K 

Cornea: Opacity (A) 3.0 3.0 2.0 3.Q 4.0 

Area (B) 1.0 1.0 4.0. 4.0 1.5 

Subtotal (A X B " 5)·.• 15.0 15.0 40.0 60.0 30.0 

~: Irritation (A) 1.0 1.0 1.0 2.0 1.0 

Subtotal (A " 5) 5.0 s.o 5.0 10.0 5.0 

Conjunctivae: Redness (A) 1.5 1.5 2.0 1.5 1.5 

Chemosis (B) 4.0 3.0 3.0 2.5 3.0 

Discharge (C) 2.0 2.0 2.0 1.0 2.0 

Subtotal (}. + B + C)ocZ 15.0 13.0 14.0 10.0 13.0 

Tota1 Sc.ore: 35.0 33.0 59.0 80.0 48.0 

Sodium Fluorescein Exam: --- POsitive Positive Positive 

Percent Corneal Surface Positive: 100% 50% <5% 

~: 

Corneal Epithelial Damage 1 Peeling X X X X X 

Purulent Discharge X X X X X 

Blanching, Conjunctivae X X X X X 

Petite Hemorrhaging, Conjunctivae X X X X X 

Vascularization of Carneal Surface X 

Pannus X 

163-'500 
,•' 

'· 

'Intemational Resear:_L :_;nij Develop;;!}_ .'~-"Cu: porat!o;; 

!'age 15 

IV. l'RIHARY SKIN IRRITATION STUDY IN THE ALBI!\0 RABBIT 

~I 

A. ~!E'IHDD: 

Three male and 3 female New Zealand White rabbits (obtai~ed from 

Kuiper's ~bbit Ranch, Gary, Indiana) w~re used for this stUdy. The 

rabbits weighed from 2120 to 2230 grams at the beginning of the study. 

They were individually housed i,n hanging wire-mesh cages in temperature ., 

and humidity contrOlled quarters. They vere maintained in accor~ance 

with the recommendations contained in R~E.W~ Publication No. 74-23 

(N .. I.H.) entitled "Guide for the Care and Use of laboratory Animals". 

tV'ater and Purina Rabbit Chow- ue.re. available ad libitum. 

The hair was removed from the back of each rabbit (20-30% of the 

body surface) with an electric clipper. The skin of 3 of the rabbits 

was abraded with a scalpel blade~ The abrasions penetrated the stratum 

corneum, but were not deep enough to cause bleeding. 

A volume of 0.5 milliliter of the test material was applied to the 

back of each rabbit. ---.~<· The application sites were·~then covered 'With gaUze 

bandaging and pccluded with Saran tJrap. Four hours later the bandages 

~re removed and the sites were washed with tepid tau water and examined 

for skin irritation (in accordance with the scale on page 17) and for 

corrosion. These examinations we'te :x:epeated at 24, 48 and 72 hour.s. 

B. RESULTS: 

The table on the following page presents the grade of effect 'dth 

time. Table 4 presents the individual rabbit scor~s and the computed 

primary irritation score of 2.2, 

Based upon the results obtained, the test material wOuld not be. con-· 

sidered a primary skin irritant or a corrosive material. 

The test material would be further classified, based upon the scores 

obt:ained, as being mildly irritatit1g to ~he skin tvh!=;n e'\.~aluated uSing 

the method described on page 17. ' 

163-soo 

\~ .· 
!!·..> 

· :·y/ h~~ \·:-.i -ir~ !) ;ltP :1 i . :t.·:>;-;,·~._:q-.:·,:."U f~Jf! -·~.·----· -. --·-----.:..:-:.....;.,;..,,w:";;_· ... ::._,, w, ~--,.;.,.."~:.:~.! .. _·.· ~:~.;·: ·•·••-• ~--- _ .... . . • ' t 

~u!nber ·of. Ard.mais :_Exhibitin.~ Si@s ,~ith Sc0t"ing '.'Value 11 

Observations 

Erythema, 

Eschar 

Formation 

Edema 

Formation 

163-500 

Value 

0 

l 

2 

3 

4 

r:t 

1 

2 

3 

4 

l:lours 

4 24 48 72 

3/3 3/3 3/3 3/3 

3/3 3/3 3/3 

3/3 

Abraded Skin _ 

Hours 

4 24 46 n 

1/3 

3/3 3/3 3/3 2/3 

3/3 3/3 3/3 

3/3 
;., 
' . 

~t 100 Residue: 

!ABLE 4. -

.... - ~ ·.: . 

,Pa~~ 18 

I 

:~: . \:j; 

_ Eiythema. I Edema . ·. 

-~ 

I. ~ 

Observation Period (Hours) I Ob~ervati~ri p"eri6d (!!ours) . 

' Animal No. /Sex 4 ·24 48 72 4 24 48. 72 

'1 • ' 

28952, Female 1.0 l.o• 1.0 1.0 ? n L5 L5 

28959, Male 1.0 1.0 .1.0 1.0 _,_ 2.0 1.0 !.0 1.0. 

28977. Hale 1.0 1.0 1.0 1.0 2.0 1.5 1·5 . 1.0 

Total 3.0 3.0 3.0 3.0 6.0 4.0 4.0 3.5 ~ ;, ....... --· ..... , 

Abraded Skin 

Erythema .· I Edema 

1----

Observation Period (Hours) I Observation Period (Hours) .. 

Ani cal No. I Sex 4 24 48 72 4 24 48 72 

28953, Male 1.0 1.0 1.0 1.0 I 2.0 I 1.5 0.5 0.5 

28956, Female 1.0 1.0 0.5 0 I 2.d 1.5 !.0 0.5 

28958, Female 1.0 1.0 0.5 0.5 I 2.0 1.5 1.0 0.5 

.. 

' 

Total 3.0 3.0 2.0 1.5 6.0 4.5 2.5 1.5 

-- Calculation for Primary Skin IrritatiOn Score (~~aTe "" the avera&e o~ all the e·!:yi:he~a sCores 

plus the average. of q.~l th~ ~dema scores): (2L5 -: ~.4J.- + (3.2. t _24) ~ 2~!!~· · 

a - slight fissuring and coriaCeo~sness 

' 
. ' ' 

! 

~-t i 

I v. 

[llternational .Research and {:epcf,lp:nem· Cotporution ··. - ... _.-... -------------.. --·-------·---·-··-

Page 19 

ACUTE DEP~!AL TOXICITY STUDY IN THE AL3INO RABBI! 

A. METHOD: 

Ten tnale and 10 female NE!.w Zealand t.ffiite rB.bbits (obtained from 

Kuiper's Rabbit Ranch, Gary, Indiana) were used for this study. The 

rabbits weighed from 2304 to 2923 grams at the beginning of this study. 

They were individually hOused in hang~ng wire-mesh cages in temperature 

and humidity controlled quarters. They.were maintained in accordance 

with the recommendations contained in R.E.l.J'. Publication No. 74-23 . (N.I.H.) entitled "Guide for the Care and Use oi'.Laboratory Animals"~ 

Water and Purina Rabbit Chow 't.re.re available ad libitum. Body -weights 

were measured ini.tially and at ,, 14 days. 

The ten Tabbits wexe divided into 5 groups of 2 male and 2 female 

rabbits each. The hair was removed from the back of each rabbit (20-

30% of the body surface) with an electric clipper. The skin of one male 

and one female in each group was abraded with a scalpel blade. The 

abrasions penetrated the stratum corneum, but ·t-rere not deep enough to 

cause bleeding. 

The ~est material was applied once only to the backs pf the rabbits 

at the following dos.age levels: 1250, 2500, 5000, 10000 and 20000 mg/kg. 

The area of appl;cations was wrapped with g·auze bandaging and occluded 

with Saran Hrap. Twenty-four hours later the bandages were removed and 

the backs were washed with tepid tap water. They were observed at 24 

hours and daily thereafter for a total of 14 days for mortality only. 

:_,: 

163-500 
Dosage 

Level 

m~/kg 

./Pl250 

.{1:'2500 

5000 

10000 

20000 

'•.•':! 

·-". 

Ilzrehiatfonal.i.?..e5er.)rch dii~}' Oi{i.~diopnudnt C,(,rlXir··t,lf:Jn .. ' . --·.-.-...:...,;,;_~ --:----·-. ----.~~~--· _.' -·---. .:...:~_,_;;.,,~.~-:-·..::--~. ,-

Page .2Q 

B. RESULTS: 

· 1. ~ortality and LD80 Values: 

Hrs. 

0-4 

~ F 

Dose - t-lortality Data 

Number of Deaths 

naxs Total 

l 2 3 4 5 6 . 7 14 I Mortalities 

H F ~~ F H F ~~ F M F M F H F Male Female 

0/2 

0/2 

2 2 2/2 

2 l 2/2 

2 2 2/2 

The Acute Oral LDso Val~es and 95% Confidence Limits 

Male Rabbits: 3535 (1768 - 7071) mg/kg. 

Female Rabbits: 5000 (1250 - 20000) mg/kg. 

0/2 

0/2 

2/2 

l/2 

Z/2 

Combined Male and Female Rabbits: 3969 (2916 - 5400) ~/kg. 

Slope 

Male Rabbits: 1.11. 

Female Rabbits: 0.55. 

Combined Male and Female P~bbits: 0.83. 

Statistical References 

Totil.l 

0/1) 

0/4' 

4.!4. 

3/4 

4/4 

ll.reil~ C. S. 1952. Tables for Convenient Gal_c::.ulation of 'Hedian 

Effective Dose and Instruction in Their Use. Biometri_cs', 8: 

249-263. 

2

Thompson, lV •. ~· and Wi::il, c. s. 1952. On the ConstruCtiori of 

';(.'ables for HOving Average Interpol~tion. Biometrics, 8: 51-54. 

3 

Eby, R .. 1957. Statistical Tables fo-r DOse Evaluat:ion:J RepOrt 

No. 5711. 'Miles-Ames Research La~oratory, Elkhart, Indiana* 

·: ... ·. .. .... :·-:- .. ... ;: 

163-500 

~ .. 
... ~ ., . 

. ' ' ~ . . •' . J 

1 

I 

lJiternational R.esearih and D:: rciu1i .. 'nen/ ~~· ··.:.'fi()rctrion . ·--. ---· . ··-·-. -·------·---,·-·----- --',-----,". . s;;· \j 

Page 21 §l. 

·~-··. 2. Bodv Heigh~s: 

The fOllowing body 'tvei~hl:s were obtained during the 14-day observation perio_q: 

Dosage 

I.e vel 

(mg/kg) 

1250 

2500 

5000 

10000 

20000 

163-500 

Individual 

Rabbit No. 

29455 

29457 

29450 

29452 

29225 

29285 

29222 

29242 

29281 

29283 

29280 

29282 

29451 

29453 

29454 

29456 

28879 

28923 

28954 

28980 

Sex 

11ale 

Hale 

Female 

Female 

Male 

Male 

Female 

Female 

Male 

Hale 

Female 

Female 

Male 

Hale 

Female 

Female 

}!ale 

Male 

Female 

Female 

'· 

COntrol 14-Day 

Weight Weight 

(grams) (grams) 

2517 2800 

2580 2630 

2575 2860 

2585 2810 

2900 2427 

2716 . 3000 

2923 3354 

2407 2523 -----~ --· . --~ 

2574 Died 

2394 Died 

2759 Died 

2398 Died 

2380 ' Died 

2550 Died 

2585 2680 

2314 Died 

2360 Died 

2350 Died 

2400 Died 

2304 Dit-1d v·. 

~ 

#--· .kf/ ~/.) 

'/)J 

. '1/ ~ 

. D1~ 

.o~o. 

.~.It-] 

. otf~, 
.. , 

• 

·~c I 

internatioNal Researc}7 and Development Corporation 

Page 22 

VI. ACUTE ORAL TOXICITY (Lo50) STUDY IN RATS 

A. METHOD: 

Thirty male and 30 female rats of the Charles River CD strain (obtained from Charles River Breeding Laboratories Inc., Portage, ~Chigan), 

weighing from 200 to 280 grams, were used for this study. The rats were 

~oused by sex in groups of 5 rats per cage, in hanging wire-mesh cages, 

in temperature and humidity controlled quarters. They were maintained in 

accordance with the recom.rnendations contB.ined in H.E.'t-1~ Publicatioi:t. No. 

74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals". Hater and Purina Laboratory Chow "ivere availa~l~ ad libitum, 

except for an overnight period immediately preceding o~al adm1nistration 

during which food, but not water, was Yithheld. 

The test material was administered orally by gavage as an emulsion 

in corn oil at the folloWing dosage levels to male and female rats: 215, 

464, 1000, 2150, 4640 and 10000 mg/kg. 

Five rats of each sex were used at each dosage level. VOlumes of 

10 ml/kg of body weight were administered at ell dosage levels with the 

exception of the 10000 mg/kg dosage level which was administered at a 

volume of 20 ml/kg. 

All rat$ were observed for mortality, only, during the fir~t four 

hours after dosing, at 24 hours and daily thereaft~r for a t~tal of 14 

days. 

Body weights were recorded initially and at 7 and 14 days. 

163-500 

· ... 

•" 

···~ 

·~ ;:· ... 
.. b• : 

• ,. 0:> •' 

Dosage 

Level 

mq/ka 

215 

464 

1000 

2150 

4640 

10000 

75'75- "'lCODf' Sfi' ,:;_,..-

fntunatiomtf Research and Development Corporation 

Page 23 

B. RESULTS: 

1. Mortality and LD50 Values: 

Hrs. 

0-4 

}! F 

Dose - Hortality Data 

Number of Deaths 

Days Total 

1 2 3 4 5 6 7:'14 Mortalities 

M F M F H F M F M F M F M F Male Female 

0/5 

0/5 

1 3 2 1/5 

5 5 5/5 

5 5 5/5 

5 5 5/5 

The Acute O~al LD50 Values and 95% Confidenc~ Limits 

Male Rats: 1258 (926 - 1711) mg/kg. 

Female Rats: 680 (535 - 864) mg/kg. 

0/5 

0/5 

5/5 

5/5 

5/5 

5/5 

Combined Hale and Female Rats: 924 (719 - 1188) mg/kg. 

Slope 

Hale Rats: 1.00. 

Female Rats: 1.00 

Combined }uue and Fewale Rats: 1.00. 

Statistical References 

Total 

0/10 

0/10 

6/10 

10/10 

10/10 

10/10 

1weil, C. S. 1952. Tables for Convenient Calculation of Median 

Effective Dose and Instruction in Their Use. Biometrics, 8: 

249-263. 

2

Tbompson, l.f. R. and l-leil, c .. S. 1952. On the Construction of 

Tables for Hoving Average Interpolation. Biometrics, 8: 

51-54. 

3

Eby, R. 1957. Statistical Tables for Dose Evaluation, Report 

No. 5711. Niles-Ames Research Laboratory, Elkhart, Indiana. 

163-500 
International Research and Development Corporation . ' ;,:. 

,~~i/ 

Page 24 ~ 

~f 2. Body l~ei.ghts: 

The following body weights were obtained duri.ng the 14-·day observation period: 

Dosage Control 7-Day. 14-Day 

Level Individual Weight Weight Weight 

(mg/kg~ Rat Number Sex (grams) (grams) (grams) 

215 76980 Hale 221 296 310 

76981 Male 200 280 303 

76982 Male 211 268 307 

76983 l1ale 225 287 322 

76984 Hale 231 297 '322 

76985 Female 200 215 225 

76986 Female 202 213 224 

76987 Female 204 220 230 

76988 Felnale 200 218 226 

76989 Female. 203 223 228 

464 76738 Male 240 280 291 

76739 Male 210 268 295 

76740 Male 228 287 306 

76741 Male 222 249 266 

76742 tlale 233 272 283 

76718 Female 200 222 240 

76719 Female 216 246 245 

76720 Fe:r.ale 224 241 252 

76721 Female 208 226 226 

76722 Female 221 254 242 

1000 76733 }[ale 270 269 293 

76734 }!ale 258 Died Died 

76735 Male 240 276 300 

76736 Hale 229 232 225 

76737 Male 240 279 279 

76713 Female 236 Died Died 

76714 Female 240 Died Died 

76715 Female 201 Died Died'. 

76716 Female 211 Died Died 

76717 Female 217 Died Died 

163-500 
,, :···-·' 

88-/~8'8 

!1 1 :-e.: i :~rrional F.i; .. -~earch u__;zd Llev! ' .,. , .• ,--~ t' ',, ,. ' 

--·--·-·····---·-·-.. ------.•. ---·~··- .. -. ----"---· : .. ·-~:-.~1 jJ(JJ ~-~ li)/t 

Pa~e 25 g 

SJ 

2. Bodv t{eights (Cont.): 

'lf'i 

Dosage Conttol 7-Day 14-Day 

Level Individual Height Hei.ght lveight 

Cms/k£l Rat Number Sex (grams) (grams) (grams) 

2150 76728 Ma:le 245 Died Died 

76729 Male 280 Died Died 

76730 Nale 250 Died Died 

76731 Hale 221 Died Died 

76732 Nale 230 Died Died 

76708 Female 214 Died Died 

76709 Female 220 Died Died 

76710 Female 219 Died Died 

76711 Female 218 Died Died 

76712 Feniale 216 Died Died 

4640 76723 Ma:le 244 Died Died 

76724 Male 232 Died Died 

76725 Male 229 Died Died 

76726 Male 260 Died Died 

76727 Hale 235 Died Died 

76703 Female 224 Died Died 

76704 Female 221 Died Died 

76705 Female 230 Died· Died 

76706 Female 210 Died Died 

76707 Female 231 Died Died 

10000 76694 }!ale 202 Died Died 

76695 Male 225 ·Died Died 

76696 Male 210 Died Died 

76697 Male 220 Died Died 

76698 hlale 215 Died Died 

76689 Female 200 Died Died 

76690 Female 203 Died Died 

76691 Female 205 Died Died 

76692 Female 204 Died Died 

76693 Female 202 Died Died 

163-500 
,~"'~" "t··" ~~1;~,t~~!l,f!!4~,. :~'ft~~f P . tl~a. ~ UNITED STATES •ENVIf{g~~-~~.TJl.L P~OTECTIO~ 'AGENCY 

.. ',-,:.-..,._,..,...# WAStjlN,f!(Jf'!iD.C. 20460 ·••, 

· ··· ' · ·. , :··; sis( ~\·mJ 9 ·. · .. · '! · 

;:·~·; 

:. -·:. 

:.,:, "' -; 

: -~ ,,• 

. 'cERTIFI/eD . }!AIL 

•RETURN .RECEIPT REQUESTED :~•Sc-:•c;•, .. ;; 

·.MJ:. ·Thomas R. LoY . :•Manager, Regulatory Activities 

Velsicol Chemical Corp. 

341 East Ohio Street . :-Ch±cago, IL 606.11 

)-- .. : ' :,}::.;; ' . :..· . 

: : OFFICE OF TOXIC SUBSTANCES 

. ·::.:· 

'· :-·. 

•• 

~e~:-:v::~us dates you submftte~~;~:ormation (see attached '·, 

1is.ting of submissions) under the,op_i;oji:isions of ,.section ·a (e) 

·•·Of the 'Toxic Substances Control'i•Act?i:(TSCA). . Yoii indicated 

that some of the information:irii,'youi'«s\ilimiss±oris is consi- :~ed ·confidential. . · .:t :,·: .. •':'(':·•'·,;!.:(•···· ·.: ,:.;, ,: . _ .... ·,· ~-· . ·-- ... __ ., 

'The Environmental Prot~9tiC.t1·;l\.gib't1cy (EPA) has been 

• .receiving •. many' requests fox:·. acicess:;.to'' notices. submitted to 

EPA under section B (e) of Tsc:A;c._···Acco'i:-dingly;.·EPl,\. must make 

.a ,final confidentiality deteriitination·t."concerning ·the treat.: 

-:ment of the information in.·:,your:·sul:ini':fs:~'ions~. · J;n order to_ 

'l!lake that determinat·ion, EPA rieeds•Y•fur'ther information from 

1rou. :Under EPA's regulations on the-;,:t'reatment'.'of information claimed as confidentiahin•,4o.: .. cFR'Part 2: (41 FEDERAL ~GISTER 36902, .September l';/1976)';;,:;!{:9,i;(have·.ffi1 · .. opportunity 

to submit comments to substantiatei!-'yc:Hit.:• claim ·.of' confidenti-

-alit_y. . ; ·',t:·i-;: ,''':':\:-:-~:~:;:.;·,\':,·, . ·,;.. .. ·.·· 

'To comply -with these requir~:·;[~~:; you m~s~. indicate 

·"lllhich portions .of your submissions :are;:: claimed as confiden- . ctiaL · .Be .specific as to page;·::paragraph, or sentence as 

.appropriate. For those portions_ thaj:.iyou identify as confi-

•dent~al, you must address the:'.:follo~ing:,:questicins; In 

.answering the questions, be as'': spec~f:ic'! as poss:i,ble, gi vei 

·-examples if necessary, and,•·c;:oi::tnect':,;,:f;iie;'_e;pecifip'f<lnswers ·to 

: A:he .specific claim .. d port\~r.s.;j',··t.~MJ:!Ii~~ri;;;~'; . ),;':;0-:','' . · =-· ~- For how long a ·pe_~.iQCJ.:"f;do~:_y,·_o~U-:.aesire·::;confidentia1 __ 

; t.r':la~ent? May EPA discl~se\':thi#V'i:!ifC'f~mati~ri :'ilfter a cer--

ta:Ln date or after the occurrence·.:of·>•a spec:Lf:Lc event? · · ::~:+.-:· ... \;:~~:: .. )/;~~-~--; -:-~'s:;g:~:b · · ;~----

-·: 

·, 
~,r···-;:~(or?~.~!J-if' '::·: ,. 

... _,_ 

.unde~1~ed 

-.::x ·.-~·:~;.'>:-~~- - .. ;:: !.~?,: :· ·:; ,:-- , .. -,, 

What measures have•yoii;~aken to ·g'u'ard ''against'' disclosure ·of tnis information· to··: others? · 

3. To what exte~t have•y~J-"~l§~ibseJ;fhis informaticili 

•:to others, and what precautioiis.:hatre'i::iou taken. in connection 

,With the disclosures to protec:t agid.nst furt:,her disclosure~ ':o 

~ 

-4.1 Have there been any confidentiality determinations 

....made by EPA, other federal ::agencieS 1 ':or courts in connection 

·with this information? If' so, please .enclose copies. :~u:~ 

• 

s. Do you flssert that 'disclosure. of thisinforma:tion ~uld be likely to result in siibstant.i;h harm to your com-

•petitive position? If so,· what ··are.'thdse harmful effects, and why should they be regarded as'siibstantial?. ·what ·;ts the 

--causal relationship between· tiie disclosure and the harmful effects? · · ·. - · • '· ::.::\: ·,._ .. 

·.' ·6. Do you assert that this :L:nformation was voluntar- ~ly submitted as defined in 40 CFR~2;20l(i}? If so, would 

the disc.losure of this informatim',;,'tim'd· to lessen the ·avail-

'<lbility to the Government bf·•siniilar·co'i'nformation in the·· · c:future? Why? ~:.;:;., __ ·' 

.:In making your claims of: ,;onfide'nhalit/ and providing 

:responses to the above questions' :ypu. should keep in mind 

that under section 14(b} of TSCA,•:"data from health and 

safety studies" is not entitledtq·c:oiJ:t;idential treatment, 

·.except to the extent ·that. disclosure:,a;:· such data would 

reveal either the portion of a mixture•comprised of any of 

:the chemical substances in the mixture or the·_pracesses used 

in manufacturing or processing a ch·emical substance or 

·mixture. Any claim of confidentiality•_.for data from health 

and safety studies that goes beyond:these two types will be ... en:t' ed. "· ·. ·•· · · ' ""' ~- i,': . 

·.~ -~ 

:t:n ·responding, please 'refereba~· '1:he pertinent document 

<control number and address .your respciilse to: . . _ . ,•• ......... ·." ... . 

·OTS Document contr~l:'Officer _: '.<· ·, '' 

Environmental Protecihbn: Agency; ,, office of Toxic substances (WH;-;5,57} -401 M Street, S.W. '-~··'"._~_.-.. 

washington, DC 20460 " _, -~·:;: 

Your comments must be received by EPA not.•.later than 

'the .15th day (Saturdays, sundays, ,and federal holid.ays ·-excluded} after the date on which ·you receive this certified 

."J.e.tter .• Failure to submit comments_.wit:hin thaj: period .will 

<·:be -treated by EPA as a waiver or .. wit1>,drawal ,of ,:-your .rljquest . ·• 

... : ,.;·~\:.;; · .. ·i;<:·~,~::~\~;~,~~\J/. : ;~+r:r.::: · ·.;··~i:·_;;. ~, >. 

·"·'· 
''.~tf~~~·'?;:'f~~~~{~~~~-,~-~'~\~i~·· ·:for confidential treatment, .•and_:;<,the':£ihformation'C:wiH be'.-made 

.,avai1able to the public w'ithoutp~tirtliii.r:~~iiotice ;fo•.i_ygu. -You 

my request an extension of 'fime:':E6r •. siibmi tting 'ypur cOin- ••. :: 

cments by contacting the :Doci:iment{';,contro-1 officer; however; 

,extensions will not ·he grai:rteid·,>eix(:epf in extraordinary· . . .. circumstances. You will •be :notified of EPA's confidential..: ·: 

,±y detprmination 30 days p'::i.O,~ -~o ·a~~_. disclosur~< ·· ' ..... •,!·.; 5·~·, .,._ - .' ... -. '. . . '' '' :_ ', · :If tlle information yciu::sill:nnit: ;-ti':> 'Ei?_l\. in ma~i.!lg your. • . --·connnents about your confidentiality'' ·cl<iiin. is not' otherwise.• ' 

:possessed by EPA and is marked'with a.designation.such as 

,"'trc:u;ie secret, u ''company confidentiaJ;~:~':_);ir other· appropriate 

·aa.bel, it will be regarded by cEPA•_,as.entitled to .confiden-' ;, 

tial treatment and will not be disclosed without'your con.::. 

•.SeiJ,t unless its disclosure is -ordered. by: a Federal.'' court. . -~ . ' . . 

. For _your use in consideririg·:· •. futilre ;subrll'issions, a copy -of the "Policy Statement on Notification of Substantial Risk 

Under Section 8 (e) of the Toxic Substances Control Act" will . . be :forwarded following. its .publication :±n_ ,the Federal · :Regfster. · · " ;,)\' ··' 

~ 

Very trt!lY yours, 

, ~ :,:; . . :v·-1 ~ >- , ~-' :_:~: ' 

q~ SFf!>~M;::tJeA.~ WoltSLQ, ···.· :.'OTS Document Control Officer -_.;-

.· 

i 

I' ' 

· .. 
:(2) 

,, I 

~) 

'{·4) 

'3/1/78 

! 

3/1/78 

'3/1/78 

' 

\.. 

·•jsubmissi~ri ·· · 

' ·;_, : 

. ·~ 

aetter .and ~:~emo . '(d,i.oxins .analysis\ 

.:J.etter arid . :attached study · ·,{isocyanate dimer) 

.Ietter and .. ;attached study 

. :!{hexabromocyc1o-

-..dodecane J 

3/1/78 ~etter and 

.attached study 

• • •{'VC-935A) 

. 3/1:/7 8 "J.""tter and 

.attached study 

I(·MC-993) 

(-6) 3/1/78 'J,etter and 

.attached <.~udy 

<(VC-948) 

.-

{7) .3/6/78 

. :-~'Ill 3/6/78 . 

:l£!tter -and 

.attached study · -!(ch1orendic 

•!anhydr ide) 

.:Letter and 

-~ttached study 

• :;(:t:ribromophenol) 

.-... -. 

· ..... 

•11E.:00376.:..,0090C,": . 

' . . - . 

-•:8E.,037-lH009l.C . 

. ' . . 

11E-037s-cio92c. 

,., 

.. sE-o37a-oo9~c , 

•. ~:·,-,1~\t~··.' -.:'~' :·:: :---!\j.,' . 

·' .. 

:11E-037B-0095C 
On April 12, \978, Hr~ Thomas Loy of-Velsicol Chemical Company, in 

telephone conversation with-me,waived all. confidentiality claiMs on 

tile submissions listed in our challenge--letters-of March 14 and- . ,;· 

Mardi 16, 1978. At any rate, the allotted 15-day response time already .: 

flail elapsed and the material was declassified by virtue of that fact. 

Please change all of the. per.tinent submissions til reflect th.is devel-

.opment. . ·-.... -~--; .. ;::; ~ ... ; -~-. .. : ... -\:: ~~~.~, ~- ~-: ;-:~.:-i~:2S. 
a ·-027B-•:oslC 

8 ·-0278·->:054C 

8. -0278~~1158C' 

81:-0278-fiiGOC-· 

a;: -0278-f•ll62C-' 

81:·0278-;r<I64C ,,. 

l ' J 

81:··0278~\ <IGGC ·•· 

' 

8J:-0278-IIl7JC·•' 

81: -027B-11!7JC"' 

April 

0 

0 

' 0 

we defend the ~ 

recent submisthe 

8E-0278-0048CBE-0278-00SOC .--

BE-027B-0053C rF? 

BE-0278-00 56C ..__. 

8E-0278-0059C ...-

8E-0278-0061C--

BE-0278-0063C_,_..... 

8E-0278-00GSC8E-0278-006BCBE-0278-00 IOC·,-

B!i-0278-0072C ,.IBE-0278-00:/ 4C .._ 
im-o37 s-oos?c..:,.: 

BE-03 78-0092C"'" 

l'RL: eh 

0 

0 

.Or 

<L: 

'-1. ' 
,, 

CODING FOR~ FOR SAC INDEXING' REVISED 10/15/96 ' i) : • .. 

USEPA STATUS REPORT: RESIDUE OF HEXABROMOCYCLODODECANE WITH 

ATTACHMENTS ·:" 

RESIDUE OF HEXABROMOCVCLODODECANE 
,, 

. UNiTED STATES ENVIRONMENTAL PROTECTION AGENCY . . ' ' ' . . ' . 

DATe• MBy 10, 1978 (Revised May 10,. 1979) 

••••eCT• Status Report sruq-oz?ll-ooss 

PRoM: Frank D. Kover, Acting Director 

ASsessment Division, OTS (TS-792) 

Approved_;:.:___~ 

ReV~siotl 

Needed --,-...,-

TOi WS.rren ~. Muir; -Deputy -Assifi:tS.tit Ad~iniStiator for Testing and Evaluation, OTS (TS~792) . ~ . 

Submission Description ' 

Results of acute toxicity studies of a residue of bexabtomocyclod0decane 

(FM 100) in rats and rabbits, This notice was d,eclassified on /!Pril 13, 

1978. 

Submission Evaluation 

__ ; 

It is not clear what "FM 100 residue" is. The basic compound appears to be 

a saturated ring system of 12 carbon atoms,· 6 of which contain bromine~ It 

woUld lie surprising if this compound .is readily flammable; nonetheless, the 

submission reports that the residl:Je was a ~-'flammable liquid. 11 Therefore, 

the residUe might be a mixture cont~ining an organic solvent that bUrns 

readily, although this ia not clear, . Hexabromocyclododecane should' be an , 

irritant with tissue storage properties similar to those of PBB's. It 

would therefore be of interest to find out .something about the biodegradability of''this compound and its capacity for Ste>rage iD fat depotS,' The 

important thing here is (1) what was tested, (2) did the material t~s~ed 

cOntain significant amOunts Of. the hexBbromo compoundt and (3) are ·there 

toxicity data for the bexabrOmo compound. ~: . 

Current Production and U~e 

Hexabromoeyclododecane is aPparentlY used·as a flame retaidant, No additional information on production wB.s ~ocated, nOr. is 'FM 100 entered :tp _the 

TSCA Candidate List, FM 100 is listed in the "Bromine Based Fire Retardants" 

report:, anf;l ita fire ret:ard8nt: appliCations include ABS, polymethylmethacrylllte; 

polypropylene, ·and polystyrene polymers, · · · 

This status report is the result of ·a prel"iminary staff eyaluatioD 

of inforinati<iD. submitted to,EPA rlnder. Sect:f.on S(e)' of TSCA, .· State__;' 

inentS made_ h~rein_ ~re --not-. ~0 be,._i'Eig~rd~d)lifr:":e:KpreisB.i~& ·.fiti·a~~ A8~~_C;y ·. · · policy or: intimt. ~t~ re~p~ct to ;hif~lirt{~il~~.; i:li~mi¢.a:l; .~Ail~:ie:" :. ; 

view of the status .report :sho~ld: t&ke: into conaideratio":: the. fact. '·' J' 

thai: u may be.• based ,(m :lncoinpli>t<U.ri£orinil.t:i.on':: ,. ·.•: · ·., :: ·" · . ' '." . ' .'"' · ...... " ... ·.: "''· . :~· :-..~-' _, .... ::·:, .; ... ,:/:;:•. 

"1 )·- :· •• _; ;: • ·• ,_ .... :: •• '.· •.•• : ,;:·::· :.·· -- • :· -. -:,.:·.: :~·:L.··,:.:: · _,, ~ . · ........ : \.; 

, .{·~. , .. ,· .'~:. .":·~~;~~,;~.~: ,::-::~~?,~.;,. ·: jL:~t :t.;~:~. ::~:: ·:;:·: :.}/ ~:,~.r.::·';.~ .. :;,./~_: :~·;i;::~ 
comments/RecommeOdations 

Fl! 100 is the subject of two earl.!.er submissions (SE!JQ-0278-0051 and SEHQ0278-0065). The chemical will be-evaluated as part· of the ongoing Assessment Division .. examination of flame 'retaidant technology. FM 100 may be an 

enviro;.funentally persistP.nt compound. - · ·· ~ · If . . . • . (a) 'lb.is submission, like others, Was deficient in a number of areas. 

(b) 

The notifier should be asked to ProVide physical-chemical date on 

the test substanCet gross findings aD death, clinical obs·erva.tions, 

etc., as well as answers to the questions raised ~n the evaluation 

section. 

Section 8 (b) data should be checked to detemine the commercial 

significance of this compound; if production is sUfficient, 

consideration 'should be given to CHIP and/or NIOSH/OSHA referral. 

(c) " A specif.ic request for p. 17 should be made (this was not included 

in the submission). 

(d) The submitter should be asked to support 

information presented in this submission 

conclusion of substantial risk. 

135 

his contention that the 

reasonably supports a ~~ 
::. 

' 

. . . 

UNITEDSTATES ENVIRONMENTAL PROTECTION AG\ENCY. 

WASHINGTON, D.C. 204.60 

J&.N 2 2 1979 

Mr. Thomas R. Loy Manage~, Regulatory Activities 

Velsicol Chemica! corporation 

341 East Ohio Street 

Chicago, Illinois 60611 

Dear Mr. Loy: 

_OFFICE OF TOXIC SUBSTANCES 

The Office of Toxic Substances· has performed preliminary 

evaluations of your submissions (identified in Attachment 1) 

under section S(e) of the Toxic Substw1ces Control Act (PL 

94-469). The enclosed status reports are the results of 

those evaluations; however, these reports do not necessarily 

represent EPA's final conclusions on these submissions. 

':' 

Submission of the information contained in the notices 

listed in Attachment I does not appear to be required under 

section S(e) of the Toxic Substances Control Act. Please 

refer to the March 16, 1978 Federal Register publication 

entitled "Statement of Interpretation and Enforcement 

Policy1 Notification of Substantial Risk" (43 FR 11110) for 

guidance.as to.the types of information which should be · submitted, under section B(e). If, after reviewing ~~e 

policy stq.tement and reconsidering the information contained 

in these.notices, you conclude that any or all of the 

submissions listed in Attachment. I are appropriate B (e) 

submisi!(ions, please respond to ,the information requests . pertaining to those submissions. These information requests 

can be found on the attachment. entitled "Rec;!uests for 

Further Information." In cases where you conclude in 

retrospect that an earlier submission is not, appropriate 

under sectionr~ (e) , please notify EPA of that decision. ,, : \\•,~. . 

In responding t.;''''tffii'· "Requests for Further Inf;,rnintion," or 

;in otherwise communicating wit.h EPA regarding a previous 

submission under section 8 (e) , please[\ refer to the EPA 

Document Control Number assigned to tl1at submission; I£ 

further information is to be provided1

lon more than one 8 (e)" 

\··, 

' 

.. 
' 

.. V 

2 

submission, plea;e use separate sheets for each •. As in the . ,. case. of ini tiel 8 (e) 'submissions. ·a.u responses will be . . 

placed in the public file unless confidentiality is cliolimed according to the procedures 'outlined in Section X of the · March 16, 1978 policy statement. Any confidentiality claims, should be supported by submission of information as desciri!:ied in the enclosed i tern titled "support Information for Confi- · dentiality Claims." Responses to the "Requests for Further " Information" should be received by the Document Control Officer within 45 working days of the date of this letter. ·'....-! 

Enclosures 

J. Merenda 

rector 

ment Division 
·. !( 

Subject chemical(s): 

Date submitted: 

EPA Document Control No. : 

Subject chemical(s): 

" Date submitted: 

EPA Document Control No. : 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

,;, 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): ·· Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): · Date submitted: 

EPA Document Control No.: 

' 

s.Jbject chemical(s): ·· Date submitted: 

EPA 'Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

[late submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Attachment I 

PCL bottoms, hex 'i>cL tiottoms 

9/23/77 

8EHQ-0977 -0004 

ditiromoethyl acetate 

9/23/77 

BEHQ-0977 c0005 

di cycl opentadi ene acrylate ' 

11{7/77 . 

8EHQ-1177c0017P 

benzoic acid 

11/7/77 

8EHQ-1177-0018P 

unknown 

1/13/78 

8EHQ-Ol78C0031 P 

methyl amino acetal de hyde dimethyl acetal 

3/21/77 

8EHQ-0178-0036 

polypropylene glycol 

2/9/77 

BEHQ-0178-0041 

Polyvel M-106 polymer 

9/26/77 , SEHQ-0278-0050 

FM-100 

9/26/77 

BEHQ-0278-0051 

chlorendic anhydride 

11/30/77 

SEHQ-0278-0058 

chlorendic anhydride 

11/30/77. 

BEHQ-0278-0059 

MC-948 

12/2/77 

BEHQ-0278~006.0 ·"~. : -

, ... , 

, :- r: 

~.', 
Subject chemical(s): 

Date submitted: 

EPA Document Control No·.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

" Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Da:te submitted: 

EPA Document' Control No.'"·'· 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subjec~ chemical(s): · ilate submitted: 

EPA Document Control No.: . , 

SUbject chemical(s): . · Date submitted: 

EPA Document Control No.: 

'"' 17 . 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: E~A Document Control No.: 

2 

methendic anhydride, maleic anhydride 

12/16!77. ' 

8EHQ·0278-0063 

hexabromocyclododecane (FM-100) 12/19/77 . 

8EHQ-0278-0065 

VC-93SA 

12/9/77 .. ' 

BEHQ-0278-D066 

diisopropylamino ethyl chloride,hydrochlorid 

1/11/78 

8EHQ·0278-0067P 

2,3-dibromopropanol 

1/19/78 

8 EHQ-0278-0068 

HCS·351 0 

2/15/78 

BEHQ-0278-0072 

CN-11 0-109 

2/17/78 

8EHQ-0278-0074 

un~nown 

2/7/78 

.8EHQ-0278-0075P' 

phosgene 

2/7/78 

8EHQ-0278-0076P 

dicyclopentadiene, dicyclopentadiene alcohol 

2/8/78 

8EHQ·0278-0077P 

phosphorus oxychloride 

2/8/78 

REHQ-0278-0078P 

phosgene, toluene 

2/8/78 

8EHQ-D278-0079P 
,, 

Subject chemical(s): 

Date 'submitted: 

EPA Document Control No.: 

~Subject cheiDical(s): 

.' ·--· Date sUbmitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date sub.mitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.! 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

SubJect chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Dat2 submitted: 

EPA Document Control No.: 

Subject cheffiical(s): 

Date sublnitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Docum~nt Control No.: 

' Su¥ject chemica1(s): 

Date submit ted: 

EPA Document Control No.: 

Subject chemica1(s): 

Date sUbmitted: 

EPA Do~ument Control No.: 

Subject chemical(s): 

Date submit ted: 

EPA Document Control ~o~: 

Subject chemica1(s): 

Date· submitted': 

EPA Document Cc;mtrol ~o. :. 

3 

phosphoi:'us exychloride 

2/10/78 . 8E!IQ-OZ78··0080P 

unknoWn: 

2/17/78 

8E!IQ-0278-0081P 

dioxins 

3/1/78 

8EHQ-0378-0085 

Firemaster 680 

3/1/78 

SEHQ-0378-0086 

:·.· 

isocyanate dimer of 5-t-bUtyl-1,3,4-thiadazol-2-Yl 

3/1/78 

8EHQ-0378-0087 

residue from hexabromocyclododecan~ 3/1/78 / 

8EHQ-0378-0088 v 

chlorinated norbornene 

3/1/78 

8EHQ-0378-0089 

VCC-935A 

3/1/78 

BEHQ-0378-0090 

MC-993 

3/1/78 

8EHQ-0378:-009l 

VC-948 

3/1/78 

8EHQ-0378-0092 

chlordene epoxide 

3/1/78 

8EHQ-0378-0093· 

chlorendic anhydride 

3/6/78 

8EBQ-0378-0094 

tribi'omophenol 

3/6/78. 

SEHQ-0378-00~5 

derivative 
SUbject chemicia~(s}: 

Date submitted: 

EPA Document Contl:oi' No.: 

' 

Subject chemical(s): " 

Date Submitted: 

EPA DOcument; ContrOl No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No .. : 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical (s): 

Date submitted: 

EPA Document Control No.: 

Subject chemica1(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject ~hemical(s}: 

.. Da.te sUbmitted: 

EPA Docum~nt Control No.: : .. : 

Sub§'ect chemical(s): · :· Dat~ submitted: -

EPA DoCument Control No.: 

Subject chemica1(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Co~troi No.: 

dicyclopentadiene 

3/7/78 . 

8EHQ-0378-0097 

VC:::948 

3/7/78 

8EHQ-0378-0098 

f!C-984 

3/16/78 

8EHQ-0378-0100 

chlorendic anhydride 

3/1.6/78 

8EHQ-0378-0101 

VCC-935A 

3/16/78 

8EHQ-0378-0103 

MC-984 

3/27/78 

8EHQ-0378-0107 

methanol 

3/27/78 

8EHQ-0378-0108 

:1. , .. -..... 

. · :.· ,,: }. .' I 

hydroxyac.etaldehY.de dimethyl-·acetal 3/27/78 ,r· . c , •• 

8EHQ-037B-Oi11 

benzene 

3/27/78 . 8EHQ-03 7 8-0112 ·J,"· 

methyl acetate 

3/27/78 . 

BEHQ-0378-0114 

FM-680 

3/31/78 

8EHQ-0478-0115 

' .; 
( 

Subject chemical(s): 

Date submitted: 

EPA DOcument Control ~o.: 

Subject chemical(s).: 

Date submit ted: 

EPA Document Control No.: 

Subj ec t\~Chemical (s) : 

Date submitted: 

EPA Document Control: No.::; 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemi.cal(s) :' 

Date submitted: 

EPA Document Control No.:, 

Subject chemica1(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemica1(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemica1(s): 

Date submitted: 

EPA Document Control No.: 

Subject'chemica1(s): 

D;ate submitted: 

EPA Docum~,P.t. Control N~~: 

Subj'~c t chemical (s): 

: Date submitted: 

EPA Document Control No.: 

•Subject cbemica1(s): 

Date subtriitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Do.cument Control No.: 

Subject chemica1(s): 

. Date submitted: 

EPA Document Conti:'O'l No~; 

.:'-.!'' \, :>· 

5 

tei:rabromobiSphenol A', PNA' s 

3/31/78 . 8EHQ-041'8~0116 

PNA's 

3/31/78 

8EHQ-0478-0117 

unkrlown 

3/31/78 

8EHQ-04 7 8-0118 

bromoacetaldehyde dimethyl acetal 

3/31/78 . . . 

SEilQ-0478-0119 

sodiuin acetate 

3/3l/78 

BEHQ-0478-0UO 

dibromoethyl acetate 

3/31/78 

BEHQ-0478-0121 

PHT-4 

3/31/78 

8EHQ-0478-0122 

vinyl acetate 

3/31/78 

8EHQ-0478-0124 

sodium bromide 

3/31/78 

8EllQ-0478-0125 

bromoacetaldehyde solution 

3/31/78 . 

8EllQ-0478-0126 

chlorendic anhydride 

3/31/78 

8EllQ-0478-0l27 

tetrabromobisphenol A (Fll BP4-A) 

4'/17/78. 

BEHQ-0478-0130 

3-bromo-2,2-:dimei:bylpropyl-:2-ch1oroethyl-2~ 

.bromoethy1 phosphate · · 

4/17/78 - .. 

BEHQ-0478~0131 

; . . : 

' 
subject chemical(s): 

Date Submitted: 

EPA Document cOntrol No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA D9cument Control No.: 

subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

subject chemical(s) : 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemica1(s): 

Date sUbmitted: 

EPA Document ,control No.: 

Subject Chemical(s): 

Da'te submitted: 

EPA Docum~Dt Control NO.: 

su~.Ject chemical(s): 

· Date submitted: 

EPA Docvment Control No.: 

Subject chemica1(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date. submitted: 

EPA Document Control No.: 

subject chemical(s): D~te submitted: 

EPA Documerit Centro~ No.: 

6 

MC 935A 

4/17/78 

{}) 

·'' 8EHQ-0478-0132 ,,, 

vc 984 

4/18/78 

SEHQ-0478-0136 

FM 100 

4/24/78 

BEHQ-0 4 7 8-013 7 

DCPD, DCPD alcohol, 

4/24/78 

8EHQ-0478-0l38P 

VC 935A 

5/1/78 

8EHQ-057 8-0141 

FMBP4A 

5/1/78 

BEHQ-0578-0142 

benzyl chloride 

!-propanol monoester of tetrabro~ophthalate 

5/1/78 ,, 

BEHQ-0578-0143 

CN-110-356 

5/l/78 

BEHQ-05 7 8-0144 

VC 948 

5/1/78 

8EHQ-0578-0145 

FMPHTf, 

6/5/78' 

SEHQ-0678-0171 

VEL 4441 

6/2/78 

8EHQ-0678-0172 

MC 984 

6/2/78 

SEHQ-0678··0173 

CN 010-.073 

6/2/78 

BEHQ-0678-0174 

n 
~~J. r. 

Subject chemica1(s): 

Date submitted: 

EPA DocUment.Coritt-oi No.": 

Subject chemical(s): 

Dat'e ·submitted: 

EPA Documen.i: Control No.: 

Subject chemica1(s): 

Date submitted: 

EPA Doc'ument ContrOl No.~: 

Subject chemica1(s): 

Date submitted: 

EPA Document Control No~: 

7 

CN l10.:.335 

6/2/78 . 

8EHQ-0678-0175 

VEL 4083 

6/5/78 

8EHQ-0678"-0l76 

DMIC 

6/2/78 

8EHQ~0678-0177 

., 

2-bromo-1,1-dimethoxyethane 

6/6/78 

8EHQ-0678-0179 

~ .. -~ 

Subject chemica1(s): 

Date submit ted: 

dicyclopentadiene, benzoyl chloride 

6/2/78 

EPA Document Coritrol No~: 8EHQ-06 78-0180 

Subject chemical(s): 

Date submitted: 

dipropy1ene glycol dibenzoate 

6/1/78 

EPA Document Control No.: .. 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemica1(s): 

Date submitted: 

'EPA 

,, 

Document Control No.: .. Sub'j ect · phemical(s): 

'bs.:te submitted: 

EPA Document-:CO:'Itrol No.: 

8EHQ-0678-0181 .. 

unkno\-!0 

6/6/78 

8EHQ-0678-0182PS 

2, 3-d-ihromopropanol, 

6/9/78 

8EHQ-0678-0187 

MC-948 

6/14/78 

8EHQ-0678-0188 

... ' 

Sub:ji!ct chemical(.•): VC-984 

; Date submittea'''· ~/14/78 . EPA Doc,ument ·Control No.: . -~~HQ-0678-0190 

' ~ ....... 'l .Subject chemical(s): vc 9"5.'\. 

Date submitted: 6/14/iB~ . 

EPA Document Control No.: 8EHQ-0678-0191 :: -.. ~ ... 

FMPHT4 diol 

Subject chemical(s): 

Date submitted: ""' '>>-. 

~';,. ... 

EPA Document Control No.: 

VEL 3838 

6/19/78 

8EHQ-0678-0193 ""' ,, . 

'"·: 

Subject chemiCal(s): 

· Date submitted: 

EPA Document Control No,: 

VEL 4038 

6/19/78 

8EHQ~0678-0194 

,,_,, 

·,,, .. 

1: 
Subject chemical(s): 

Date submitte~: 

EPA Documerit Control No.: 

" 

Subject chemical(s): 

Date ·submitted: 

EPA Document Control No.: 

'· 

Rubject chemical(s): 

·· '; Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Co~trol No.: 

Subject.chemical(s): 

Dqte submitted: 

EPA Document Control No.: !•" 

Subject chemical(s): 

:' Date submitted: 

EPA DoCument Control No.: 

. Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document ContrOl No.: 

8 

VEL 4609 

6/19/78 

8EHQ-0678-01,95 

VEL 4578 

6/19/78 

8EHQ-0678-0l96 

VEL 3510 

6/14/78 

8EHQ-0678-0197 

VEL 3947 

6/19/78 

8EHQ-0678-0199 

dibromo-o-dichlorobenzene 

6/19/78 

8EHQ-0678-0200 

methyl-m-chlorobenzoate 

6/19/78 

BEHQ-0678-0201 

VEL 4411 

6/23/78 

8EHQ-0678-0203 

PCS 1375 

6/23/78 

8EHQ-0678-0204 

Polyvel G 100 

6/23/78 " 

8EHQ-0678-0205 

Chlorendic anhvdride 

6/15/78 

8EHQ-0678-0206 

dicvclopentadiene acrylate 

6/23/7 8 

8EHQ-,0678-0207 

VEL 4582 

6/15/78 

8EHQ-0778-02l0 

r;' 

;; 

bromodichlorobenzerie 

7/20/78 

8EHQ-0778-0220 

(neutral oils from J:iydrolv'sis 
. ' 

li 

Sub;ect chemical(s): ·nate submitted: 

EPA Document Control No.·: 

Subject, chemical(s): D.ite subfnitted: 

EPA Document Control No.: 

Subject chemical(s): 

Da:te submitted: 

EPA Document ContrOl No~: 

Subiect chemical(s): · Date submitted: 

EPA Document Control No.: 

Subject chemical(s): 

Date .submitted: 

EPA Document Control No.: 

Subject chemical(s): Date submitted: 

EPA Document Control No.: 

Subject chemical(s): Date submitted: 

.EPA Document Control No.: 

Subject chemical(s): 

Date submitted: 

EPA Document Control No.: ' 

Subject "chemical(s): 

Da:'te submitted: 

EPA Docum~t . Control No.: ;) 

Su~;{~ct chemical (s): Date submitted: EPA Doc~ment ContrOl No.: 

·subject chemical(s): 

Date submitted: 

EPA Document Control No.: 

Subject chemical(s): Date submitted: 

EPA Doc~ent Control No.: 

S~bject chemical(s): 

Date submitted: EPA Document ·control No.: 

9· 

VC 948. 

7/20/78 

BEHQ-0778~0221 

DCPD alcohol 

7/19/78 

BEHQ-0778-0222 ;,;. 

methyl-m-chloro}?ep.zoate : 7/19/78 . -

8EHQ-0778-022:i 

VEL 4578 

7/19/78 

8EHQ-O 77 8-02 24 

VEL 4441 

•7/19/78 

BEHQ-0778..()225 

methyl-m-chlorobenzoate 

7/19/78 

SEHQ-0778-0226 

tribromophenol, sodium salt 

7/19/78 

8EHQ-0778-0227 

ethylene ·dichloride 

7/19/78 

BEHQ-0 77 8-022 8 

benzo'hex S-552 

7/19/78 

8E!!Q-0878-0229 

chlarendic anhydride 

7/31/78 

SEHQ-0878-0231 
0004 

. '" 

Requests for 'Further Informatibn. 

(Subinil'lsions identified by last four 

digits of Document Control Number) 

Please: explain the terms "PCL Bo.:ttoms 11 artd "Hex PeL 

Bottoms" used in the description of the test material. 

0005 

~I 

Please submit complete copies of the studies summarized 

in .the submission and provid'e available data so~cerning the 

purity of the test material. 

0017 

Please submit any additional information which is 

relevant to an analysis of the effects described in the your 

submission, e.g., copies of medical reports, co~roborative 

information from other employee complaints, relevant litera-· 

ture, etc. 

0018 

Please submit a copy of the· company doctor's report on 

this i~cident. If the employee's condition was diagnosed by 

an allergist, as recommended in your submission, please 

''' inform. 'EPA of his findings., 

,. 

' oo:n 

--.-

Please provide any available information concerning 

possible causative agent(s). 

0036 

Please provide solubility and volatility date on 

methylamine acetaldehyde dimethyl acetal and bromoacet·• 

aldehyde dimethyl acetal. 

J' 

004! 

No additional information is request!'ci. at. t,his ~.ime • . ! , .. _ 
r;. 

-·' ~ 

' . . .... 

No additional .information is reguested at this time:. 

0051 

Please provide av.a,ilable analytical data ci~ the corn..; . positions of the rnix:tures tested (FM-100, Lot 53 and Residue.· 

of Lot 3322). Data on .the physical/chemical proper'ties of 

these substances would also be helpful. · · 

0058 

Please provide information on physical and chemicai 

properties of chlorendic anhydride which are relevant to an 

assessment of hazard to aq~atic organisms. · Data on water 

solubility, rate of hydrolysis to chl6rendic acid, pka of 

chlorendic acid, degradation of chlorendic anhydride. and 

chlorendic acid are examples of the types of information 

which would be useful. 

0059 

~ . . . . 

The information on physical/chemical properties re~ 

quested for submission BEHQ-0278-0058 would also be useful 

for ·this submission. 

QQ2..Q. 

'."Please identify the test material (MC 948) by a 

sysifematic chemical name and either a molecular formula or a 

st;uctural formula. 

0 

. . . - ' ·- ' . ( Please submit a copy of your. safety data sheet. on .. methendic anhydride and provide the results of any medical 

evaluation conducted on the ex:posed workers' · 

0065 
·"!' 

r::·-

.0066 " .. . ·.· . ·. 1 · 6 Pleas~ p~ovide' the cHemical structure of vc 93SA, · Information on the purity of. the test mate.rial and its 

physical/chemical properties should also be submitted. Is ·. the test. material ident.ical to the commercial"substance? . Ilf 

not, please provide the'·information requested above .for 'both 

substances.. · · · · · · , · 

Has VelsiCol ever encountered Or investigated a dioxin 

contamination problem with VC 935A? If so, please submit 

such informatin~ 

Please submit a complete copy of the attending phy-: ·. 

sic ian's report. :: 

Please submit a full copy of the study from whi8h the 

information in this submission was extracted. ~ 

0072 

Please clarify the information concerning the method of 

dosing and the actual level which the animals ·received • 

. P;tease clarify the composition.of the mi><ture tested. 

Is ~e composition of CN-110-19 iqentical to that listed for 

the)"ire Master 680 oils? 

0075 

Please identify by systematic ~arne the chemical(s) 

which caused the face, neck,' and hip bu1ms when the C220 . . . ·/./ filter ruptured on December 23, 1977. •" 

0076 
-4"' 

medical reports and follow·:..up activities. 

No additional information is requested at this tim ... 

0079· 

No additional information is requested at this'time. 

No additional information is requ~sted at this time~ 

Please identify.the chemical agen(s) causirig the c~mplaints, if that information is available~ 

0085 

No additionai .~nformation is requested at this time. ~. 

0086 

No further information is requested at this time. 

0087 

Please proVide information concerning the composition, 

purity, and physical/chemical properties of the test,substance. Because of the text ·substance's potential for 

antichqliriesterase activity, you should submit any available 

information whiCh is relevant to an assessment of that 

potent.ial. Please submit a copy bf p. 18 or the II!DC re- port,~ :as. ~t is missing from· your original submission~ ,. 

' 0088 

Please provide information concerning the composition 

and physical/chemical properties of the "FM 100 Residue" 

,.which was tested~ Of particUlar interest in this regal:-d is 

the .,amount of hexabromocyclododecan present in the residue. 

Available toxicity data on hexabromocyclododecane would be 

u.seful for .Correlation purposes. 

Please describe any gross patholical findings or 

clinical observation made on the tesi: animals. Also, please 

submit a copy of page 17 of the IRDC report (this· page was 

missing from the report submitted to EPA). · 
,~f.'. 

~·· 

·.L 

No further information is requested, it this time., . . :· . 

0090 

No additional £nformation is _.rei:fUested at. this time. ... .;; 

0091 

Please submit the re!En~lts of any gros·s pathology or 

histopathology per_:formed on the test animals. Please submit 

pages 17 and 19 .,of·' the "Acute Toxicity studies in Rabbits and Rats 11 , as thes.e pages are missing from your original submission.~ · · 

Please submit a full copy of the report "VC-948, 77.1467; Acute Oral Toxicity Study in Mice: from the International Research and Development Corporation; 2-14-78, #163-514. A page was missing from the report as submitted to this office. 

Also please identify the compound by chemical: structure 

specify what the chemical is .used for, a~d the ampunts' pro~uced and used. 

Please answer the questions raised in the Toxicological Evaluation section of the Status Report of the information is available . 

. , .. 

009:i' .. No further information is requested at this time. 

0094 

Because of the equivocal results obtained from the BALB/3T3 mouse lymphoma assay, and the deficiencies in the oral LD study, please consider repeating these tests, using experimental procedures discussed in the n~ubmissi.on evaluatio':'" of the Status Report. 
-6·· 

0095 

Please identify which tribromophenol isomer.(s) was 

tested and provide any available data concerning the 

priority of the test substance. 

1.:, 

Please inform EPA of any investigat'\:'6n of potemtial dioxin contarilina~ion o.f tiibrornophenol~ \,.,Describe any 

quality control procedures which have been instituted to 

miriimize dioxin contamination. · 

No additional information is requested at this time. 

0098 

Please identify,,,by chemical structure; t11e chemical 

VC-948 (his (tribro!'[6heopentyl) pentaerythritol cyclic dyphosphate) . 

0100 

0103 .,. 

No additional information is requested at tllis time. ·:;::: 

No additional information is requested at this time. 

,, Please identify, by chemical structure, the chemical MC~935A (poly (dibromophenylene) oxide) • . : .~ 

0107 

Please provide available information concerning the 

composition, purity, and physical/chemical properties of the 

test material. Also,· please clarify the dose data~oi.e. 

what_was the concentration of active ingredient administered 

to the test animals? · · · 

0108 

No additional information is I;equested at this time. 

'·.; 
-7-

0111 

No additional information is requested at this time .• 

0112 

No additional information is requested at this time. 

0114 

No additional in. 'rmation is requested at this time. 

0115 

No additional information is requested at this time. 

0116 

Please submit a copy of the fish broaccumulation study 

mentioned in .your submission ~s soon as the study is completed. 

0117 

Please provide more information concerning the composition of the raw materials C-9 and MPB. Also; please 

describe the chemical nature and use patterns of the resins 

made from these materials. 

EPA should be informed of any subsequent developments 

in tnis matter. 

0118 

.. Please identify the abbreviated chemical names "DEBA" 

and "BADMA" by systematic chemical names and molecular 

formulas or structural formulas. 

0119 

Please clarify the relationship of the chemicals noted 

in 8EHQ-Ol78-0036 and 8EHQ-Ol78-0039 to the BADMA used in 

this study. Was the .BAD!'.A used in ·the dermal testing identical to the lot used. in this st11dy? Is MAADMA known .(or 

likely) to. be contamina~ed with BADMA? 
-:-8-

0120 - t.. 

·., 

No additional information is reques!:ed at this time. 

Please submit any 9.vail·cible info:rmatiori co:n~etning physical/chemical ,properties if dibromoetnl(l acetate. A 

complete copy of the study end a discussion of the, use 

patterns for this chemical would also be helpful. ' 

0122 

Please consider retesting the material using more , sensitive experimental procedures. 

0124 

Please identify the solvent used in this test. Also, 

explain why this solvent was used. Since the compound is 

soluble . in·water, an additional sOlvent seems unneces~ary. . 

0125 

No additional information is requested at this time. 

0126 

No additional information is requested at this time. 

0121·· 

--· 

. Please refer to the Comments/Recommendations section of 

tl)e Status Report for a discussion of appropriate submissions of substantial risk, No additional information is 

requested at this time. ' 

0130 

Please refer 

the Status Report teratology study. 

this time. 

to the Submission Evaluation section of 

for-comments on weaknessess in the pilot 

No additional information is requested at 

',: 
No additional information is requested at this time, 

Please clarify the chemical structure of MC 935A and 

provide any available data concerning the purity and phys- ical/chemical properties'!of this substance, 

Because of the discrepancy between the two mouse 

lymphoma assays, please consider retesting .so that consistent results may be obtained, · 

Please provide available data on the compoSition, purity, and physical/chemical properties of the test substance. Also describe any pathological'findings or clinical 

observations made on the test animals. 

Please submit a ~opy of the attending physician's report.· 

".• 

.,. 

014],.' 

No additional information ·is requested at this time. 

Please supply any information on skin sensitization in 

animals that was available to the dermatologist before the 

human study was done. · 

Also, pleas~ =larify what modifications were made to the standard Draize test in the skin sensitization study. 

No additional information is requested, at tiJ.is. time: 

','j• 

·.: ·, 
,, 

Please clarify the chemical name for CN-110-,356 and provide a structural formula for this compound. Available 

information on production volume and use pa::tern's for this chemical would also be of value to EPA. 

0145 

No additional information is requested at this time. 

0171 

Please provide data concerning the purity of the test substand and data on the physical/chemical properties (especially water solubility) of the substance. 

0172 

Please provide data concerning the composition, purity, and physical/chemical properties of the test substance and submit the results of any gross pathology or histopathology performed on the test animals. Also, please discuss curr'ent and projected use patterns for VEL 4441 and inform EPA if 

any plans for additional testing on 'this substance. 

0173 

Please provide any available data concerning the iden.t:ification of impurities in MC 984. If no data is ... available, a discussion of potential impurities would be helflful; Also;·plE!ase· answer the questions raised in the "S)ibmission Evaluation section of the status report. 

Please .provide data concerning the composition purity, and physical/chemical properties of the test substance. Also, please respond ·'to the questions; raised in the "Submission Evaluation" sSC?tion of th¥ Status report~ 

·,·.: 

' 
'.: ,, .·. 

-11-

···;,. 

0175 ..... , ,.. 

Please proVide data corlderning the cornpositio:ri, purity, 

and physical/chemical properties of the test substance and 

submit the results of any grops pathology or histopathology 

performed on the test animals. Also; please discuss current 

and projected use patterns for VEL.4441 and in+orm EPA of 

any plans for additional testing on this substance. 

0176 

Please .. provide data conci:!rnillg the composition, purity, 

and physical/chemical properties of the test substance. 

Also, please describe the use patterns of this substance. 

0177 

Please provide data concerning the composition, purity, 

and physical/chemical properties of the test substance. 

Information related to the compound's stability and hydroscopicity are particularly important in this case. Also, 

please describe the appearance of the rats' lungs upon 

necropsy. Did the lungs show edema or hemorrhaging? 

No additional information is requested at this time. 

0180 

/ 

, No additional information is requested at this time. 

No additional information is requested at this time. 

No additional information is requested at this time. 

,:, 

0187 ,, 

Please resolve the confusion concerning.the identity,of. 

the test substance. Was 2, 3,-dibromopropanol a componi;lnt of'·• 

the test substance? Also provide' any available 11-nlytic·al. 

data on the compositicm and. pur:lty of the test substance. • . . ··~ . 

, ... 
(( ·. 

No additional information is required at this time. 

0190 

Please refer t,o the Comments/Recommendations section of 

the Status Report for general comments on appropriate 8(e) 

submissions and.futUre·activities. 

Please provide any available information concerni1,l,g the 

composition and purity of the test material. .. ,. · 

~i 

0193 

Please submit any available information concerning the 

use pattern of the subject chemical. Also, provide availabl" 

data concerning the composition and purity of the test " 

substance. 

0194 

' Please submit. any available information concerning the 

use pattern of the subject chemical. Also, provide available 

data ce>ncerning the compostion and purity of the test sub- stance~· 

:· Please submit any available information concerning the 

use pattern of the subject chemical. Also, provide available 

data concerning the composition and purity of the test 

!lubstance. 

0196 

Please submit any available information concerning the 

use pattern of the subject chemical. Also, provide availll.hle 

data concerning the composition and purity of the test · substance. G 'i · ·"'· 
.,.13-

Please submit ap.y av~'il'aJ<le information concerning the use pattern of the subjec·t cheii\ic;tl. Also, provide available data 

substance.. concerning the composition and:purity of the test . . .. '· >,-. - · · · · · :.~·;:; 

. , I 

., .. :~ 

·~· ~ 

"""'=~.' 

this time.~~ No additional information is requested at 

Please identify the "DBDCB isomer" found on :the GC trace. 

Please submit any available·information concerning the use patterns of the subject chemical. Also, please respond to the questions raised in the evaluation section of tne · status report. 

Please provide any available data concerning the com- 'position a-nd purity of the test materiaL 

0204 - . 

. /Please submit an accurate chemical identity of Pt;:s 1375, describing a molecular structure and formula con- sis·tent with a name. Also·, please provide: analytical data ., concerning the composition and purity of the test material, any available information on·'its use patterns, and the results of any experimental blood level,determinations. 

Please provide analytical data concerning the com- position and purity of .the test material. Also, please inform EPA of any plans for further testing of this· rna~ 

terial., 

·•.: 
.:::; 

I . . . 

Please provide any availab-le analytical data concerning'· 

the identification Or characterizatiOn of impurities p.reS~iit .. in the test.substance. 

No additional information is reques.ted at this time. 

<: 

0210 

Discrepancies between the chemical name and the molec'-

ular formula have been a recurrent problem with Velsicol 

B(e) submissions. Please clarify this discrepancy for this 

submission. It is the responsibility of the submitter to 

provide EPA with complete and accurate information, sp that 

a proper evaluation of substantial risk can be made. 

Please proofread future sucmissions carefully. 

Also, please provide a description of the use patterns of this substance. Please provide histopathological findings on the test animals. If these are not available, 

Velsicol should consider initiation of t.hese studies. 

0220 

Pl:ease provide 

use patterns and/or 

022J/ 

--· 

any available information concerning 

information of the test compound. ' . the 

·· Please provide any available. information conc9rnirig the 

annual production and uses of the test compound. 

0222 

Please provide any available analyticaldata concerning 

the composition and purity of the test materiaL 

0223 

\\ r , 

No additional information is requested at this time, .·~~;: 

. ··' 

. ·~ 
'. 

-'is,... 

0224 

, Please provide a description of the use !:>atterns of' V~l·; 4578. 

:.1. 

022.5 

Please provide a description of the use patterns of.· '\IEL 4441. . ·. "· 

0226 

Please provide a description of the use patterns of methyl-m-chlorobenzoate~ 

0227 

Please address the concerns raised in the Submission Evaluation section of the Status Report. 

0228 

No additional information is requested at this. time~ 

0229 

Pl-ease"provide the chemical identity of benzoflex S'-'552 with a· specific structure of mol~cular formula and chemical 

nam~ ... 

No additional information is requested at this time. 

·.' ·'; 
CODING FORM FOR SRC INDEXING REVISED 1 0/15/86 

' &:"moD" FROJII VELSICOL CHEMICAL CORPORATION. RESPOND INS TO " 

USEPA LETTER DATED. MARCH 16, 1978 REBARDINB INFORMATION ON 

THE POLICY STATEMENT AND DATA WITH ATTACHMENT 

·' 
,, 

' . ' : ·'.' ...... 

L~n 

0 

VELBICCL CHEMICAL CDRI"ciRATIDN 

3~1 EAST OHIO STREET • CHICAG9c ILLfl'\.'015 60611 • 312·670-4::500 

Mr. Joseph J. Merenda 

Assessment Division 

Office of Toxic Substances (WH-567) 

Environmental Protection Agency 

1}01 ·M Street, SW 

Washington, D.c. 201}60· 

April 20, 1979 

"subject: Notification~of Substantial Risk 

EPA Letter - Undated 

Dear Mr. Merenda: 

In response to. your attached undated letter, Velsicol 1 s Chemical 

Risk Assessment Committee CCRAC) has reviewed EPA's March 16, 

1978 policy statement and the data within these notices, It is 

CRAC's determination that Velsicol does not consider the submissions discussed in your letter to contain evidence of substantial risk. Since Velsicol does not consider these as appropriate section B(e) subm·i:ssions, with this letter Velsicol · wishes to formally withdraw the submissions outlined in your 

letter. · 

Information requested by EPA in the attac11111ent entitled "Request 

for Further Information has not been included since Velsicol 

does not consider these as appropriate 8 (e) submissions •. This 

information wil.1- be .developed if. the Agency wishes to receive 

it. -

Thank you for your patience in this matte~C, 

you have any questions. 

Please call ~s if ,,, 

MOM: 11:>. 

Sincerely, 

vELSICOL CHEMICAL CORPORATION 

M, Olav 

Manager 

•• 

.. • 

• • • • • 

Mes serschrnidt . of Product·Registration . . v· · . 

• • • • • • • • • • • • • • . .. • • • • • • • • • ,, . • 0 '~ • ... .. ~·· • 

ll 

' • • . . • • ... •-·• • • • r,: 

• •• .. • .. .. 0 • • • • '! •: • • • • • • • • . .. .. • ~·- ..... • '·-···; -.:.:,_·: ·~··· 

; ; 
,. 

UNITED sTATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON. D.C. 20.160 

JAN2 61979 

Mr. 'lhomas R. LoyRECE\VEO Manager, Regulatory Activities · 'velsicol Chemical Corporation 

341 East Ohio Street 

Chicago, Illinois 60611 

Dear Mr. Loy: 

. l~- .• , . ,. 

Ofi'F'If.~JOF' TOXIC SUBSTANJ:.:ES 

~e Office of Toxic Substances has performed preliminary evaluations of your submissions (identified in Attachment I) 

under section 8(e) of the Toxic Substances Control Act (PL 

94-469). The enclosed status reports are the results of . those evaluations; however, these reports do not necessarily 

represent EPA's final conclusions on these s4bmissions. 

,: .. 

Submission of theinformation contained in,the notices 

listed in Attachment I does not appear to be required under 

section S(e) of the Toxic Substances Control Act •. Please 

refer toc,;the March 16, 1978 Federal Register publication . ent:\,:tled'"'Statement of Interpretation and Enforcement 

Pol!cy; Notification of Substantial Risk" (43 FR 11110) for 

guidance as to the types of information which should be sub~tted under section S(e), If, after reviewing the 

policy sta·t;ement and reconsidering the information contained 

in these not.ices, you conclude thac any or all of the 

submissions listed in Attachme,nt I are .appropriate 8 (e) 

submissions, please respond to the information reque.sts . pertaining to those submissions. These information requests 

can be found on the attachment entitled •Requests for 

Further Information." In cases where you conclude. in 

retrospect that an earlier submission is not appropriate 

under section.B(e), please notify EPA of that decision• 

In responding to the wRequeets for Further Information,• or 

in otherwise communicating with EPA regarding a previous subnussion under section B(e), please refer to the EPA 

DOcument Control Number· assigned to that submission. If 

further information is to be provided on more th.an one B (e) 

;:· 

·. < ;.:.:. 

•• • .. • . . • . . • • . • . ' ·• ... . . . :' 

: .: .. : o._.... : •• .. ... ·• . . .. ' .. . ·-' ··.·~ . •···· ..... :·:···· .•. . . .. .,. . ··~= .. : .. '!: .~:.: :~: ... ~~=: .": . . :··· .... . . •..• ·.•: .. '" 

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·.- ., ~ .. ' . :. ' 

.:.·,: 
2 : '· 

. ' ' . . ·:~1 ' . ' ,' . - . .. :: -.•. .:· 

-. n allbmission, pleaae. use separate sheets for each. __ . As in the . 

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c:ase of initial B(e) submissions, all responses wil-'l be : • ,: : · placed in the pUblic file unless confidentiality .i's claimed . according to the-procedures outlined .in Secti_on X of the , March 16, 1978 policy statement. · Any confidentiality claims 

should be supported by submission of information as described 

in the enclosed item titled nsupport Information for Confi~ · C!ential:!.ty Claims." Responses to the "Requests for Further 

Information" should_ be :i:eceived by the. Document .Control · · , -. Officer within 45 working Clays ~f the date of tl;lis letter • 

• 

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Enclosures 

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