111111111111111111111111111111111111111111111111111111111111 

# • OTS0200466 

# N OneSource. OneSearch. OneSolution. 

# ACUTE TOXICITY STUDIES IN RABBITS AND RATS WITH RESIDUE OF HEXABROMOCYCLODODECANE WITH ATTACHMENTS AND COVER LETTER DATED 

# 030178

14 FEB 1978

U.S. DepartmentofCommerce NationalTechnical InformationService

### CODING FORM FORSRC 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!ResearchandDeveiOplli,:::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"**

### " 

# ..
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### ! 

## '**I~** Synopsis • • • II.. Test !·faterial 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

## Researchcmd

## 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 Ax 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 Total maximum. , ·10 Conjunctivae (A) Redness

**(refe~s** to palpebral and bulbar conjurictivae

**exl~din~** cornea and iris)
(B)

ScoreVessels 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 TOtaloa:dtil.um "' 20 The maximum total score iris, and·conju:ncti.vae.. is the! sunfof .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:Jwould 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



### .Irrita.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.ater 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,.;iser 

### .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;gc:60'B'& ..·.

**~**., 

# • Page 7 '<. .t.:'H•lOO Residue: 

### EYe Irritation in the Albino Rabbit; ··.;_ I/.BI.:S l. Group.Obsarval:iOris

**.;,,:·-··~**.. E:.;arnination 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 iniury) 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** Scaras.


### - 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 Obse.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 Oilss:-·.-.:;,

**;: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 Bx 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 AlbtriO Rabbi·t. **·pag~** ll 

### r;.Su: 3! .(Cont.) Individual Rabbi;t Scbres RabbiI: :{urnber ?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-:eticcs 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 X5) 10.0 10.0 10.0 10.0 Coniunctivae: 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) 4.0. 3.0 3.0 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 Purulent Discharge X X X X X Blanching, Conjunctivae X X X X X Vascularization of the Corneal Surface X X

!63-500

### . 

### '



# 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 XB" 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 SodiumFluorescein 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:_;nijDevelop;;!}_

**.'~-"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. Avolume 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:1i .

### :t.·:>;-;,·~._:q-.:·,:."U**f~Jf!**

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### .._·.·**~:~.;·:** 

### ·•·••-•

**~---** 

### _ ....
. . • ' t

**~u!nber**·of.Ard.mais **:_Exhibitin.~** Si@s **,~ith** Sc0t"ing '.'Value11 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)

.. Anical No.ISex 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.Researchand {: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.

:_,:

163-500Dosage 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 LD

### 80 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. 2Thompson, lV•.



## ~· and Wi::il, 

## c. s. 1952. On the ConstruCtiori of

';(.'ables for HOving Average **Interpol~tion.** Biometrics, 

### 8: 51-54. 3Eby, R.. 1957. Statistical Tables fo-r DOse Evaluat:ion:J RepOrt



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

### Elkhart, Indiana* 

# ·: ... 

### ·. 

## .. .... :·-:- .. ...

# ;:
163-500 **~**.....

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.

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# 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.evel (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/

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### '/)J



## .'1/

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## internatioNalResearc}7andDevelopment Corporation Page 22 VI. 

### ACUTE ORAL TOXICITY (Lo

### 50) 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 levelswith 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

## DevelopmentCorporation 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. 2Tbompson, l.f. R. and l-leil, 

### c.. S. 1952. On the Construction of

Tables for Hoving Average Interpolation. Biometrics, 8: 

### 51-54. 3Eby, R. 1957. Statistical Tables for Dose Evaluation, Report



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

163-500

## InternationalResearchandDevelopment 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

!11 

### :-e.:i

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## F.i;..**-~earch** 

## u__;zdLlev! ' .,. , .•

**,--~** 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(

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# 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 )--

..: ' :,}::.;; ' . 

## :..· . : : OFFICEOFTOXICSUBSTANCES



### .·::.:· '· :-·. 

# ••



# ~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**

## · ·

**;~----** -·:

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### ... _,_



# .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 .15thday (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 •. siibmitting'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:/78 "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 

### tilesubmissions listedin our challenge--letters-of March 14 and- . ,;· Mardi 

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

### flail elapsed and thematerial was declassified by 

### virtue of that fact. Please change all ofthe. per.tinent submissions til 

### reflectth.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 submis

### the8E-0278-0048CBE-0278-00SOC .-- BE-027B-0053C r

# F? BE-0278-0056C ..__. 8E-0278-0059C...- 8E-0278-0061C-- BE-0278-0063C_,_.....8E-0278-00GSC8E-0278-006BCBE-0278-00IOC·,- B!i-0278-0072C ,.IBE-0278-00:/4C .._

## im-o37s-oos?c..:,.: BE-0378-0092C"'"

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,,



### .UNiTEDSTATES ENVIRONMENTALPROTECTIONAGENCY

. 

### . ' ' ' 

### . . ' . 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 ofwhich 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 aPparentlYused·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 chemicalwill 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

## 22 1979 Mr. 

### Thomas R. Loy

**Manage~,** 

### Regulatory Activities Velsicol Chemica! corporation 341 

### East Ohio Street Chicago, Illinois 60611 

### Dear Mr. 

### Loy: _OFFICEOF TOXICSUBSTANCES



### 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 initiel 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 

### itern 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-0977c0005 

### dicyclopentadiene acrylate ' 11{7/77 . 8EHQ-1177c0017P 

### benzoic acid 11/7/77 8EHQ-1177-0018P 

### unknown 1/13/78 8EHQ-Ol78C0031P 

### methylamino acetaldehyde dimethylacetal 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 8EHQ-0278-0068 HCS·3510 2/15/78 BEHQ-0278-0072 CN-110-109 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.: Subjectchemical(s): Date submitted: EPA

**Docum~nt** Control No.: 

# ' Su¥ject chemica1(s): Date submitted: EPA Document Control No.: Subject chemica1(s): Date sUbmitted: EPA

**Do~ument** Control No.: Subject chemical(s): Date submitted: 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** derivativeSUbject

**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-037 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 submitted: EPA Document Control No.: Subjec**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 ControlNo.: 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-0478-0118 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~**

.bromoethy1phosphate · · 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-04 78-0137 DCPD, DCPD alcohol, 4/24/78 8EHQ-0478-0l38P VC 935A 5/1/78 8EHQ-0578-0141 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-0578-0144 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-0678-0174n**~~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 submitted: dicyclopentadiene, benzoyl chloride 6/2/78 EPA Document Coritrol

**No~:** 8EHQ-0678-0180 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'ject·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 6/23/78 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 ControlNo.: 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-O778-0224 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-0778-0228 benzo'hex S-552 7/19/78 8E!!Q-0878-0229 chlarendic anhydride 7/31/78 SEHQ-0878-02310004 .'" 

### Requests for 'Further Informatibn. (Subinil'lsions identified by lastfour

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-:·. sician'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 com

### pleted. 0117 Please provide more information concerning the com

### position 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 "Sub

### mission 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 concerning the composition and:purity of the test . . .. substance.. '· >,-. - · · · ··

**:.~·;:;** 

## .,I



## .,

..

**:~**



## ·~· **~**

**"""'=~.'** 

### this 

## time.~~ No additional information is requested at Pleaseidentify 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.

·.' ·';

### CODINGFORM FORSRC INDEXING REVISED 1 0/15/86

' &:"moD"

### FROJII VELSICOL CHEMICAL CORPORATION.RESPONDINS 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** EASTOHIO 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 

## •• • 

# .. • 

## • • 

## • •Messerschrnidt .

of Product·Registration

. . v· ·. 

### • • 

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### ,. UNITED

## sTATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20.160 

## JAN261979 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'**TOXICSUBSTANJ:.: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)

;:·



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# ~-7Y 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** 

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