111111111111111111111111111111111111111111111111111111111111 • 

OTS0000947 N 

One Source. One Search. One Solution. 

INITIAL SUBMISSION: LETTER FROM ETHYL CORP 

TO USEPA RE TECHNICAL AND TOXICITY DATA ON 

BROMINATED FLAME RETARDANTS INCLUDING 

HEXABROMOCYCLODODECANE, * W/ATTCHMTS, 

DATED 5/23/88 

23 MAY 1988 

U.S. Department of Commerce 

National Technical Information Service 
One Source. One Search. One Solution. 

Providing Permanent, Easy Access 

to U.S. Government Information 

The National Technical Information Service is the 

Nation's largest repository and disseminator of 

government-initiated scientific, technical, engineering, 

and related business information. The NTIS collection 

includes almost 3 million information products in a 

variety of formats: electronic download, online 

access, DVD, CD-ROM, magnetic tape, diskette, 

multimedia, microfiche and paper. 

Search the NTIS Database from 1990 forward 

More than 600,000 government research information products have been added 

to the NTIS collection since 1990. All bibliographic entries for those products are 

searchable on the NTIS Web site at www.ntis.gov. 

Download Publications (1997 • Present) 

NTIS provides the full text of many reports received since 1997 as downloadable 

PDF files. When an agency stops maintaining a report on its Web site, NTIS still 

offers a downloadable version. There is a fee for each download of most 

publications. 

For more information visit our website: 

www.ntis.gov 

~';t~ U.S .. DEPARTMENT OF COMMERCE 

. lJj" . Technology Administration 

\ 

· / National Technical Information Service 

.,., ,. Springfield, VA 22161 
CODING FORMS FOR SRC INDEXING 

Microfiche No. 

OTS0000947 

FYI-OTS-0794-0947 84940000047 

05/23/88 07/26/94 FYI 

GULF SOUTH RESEARCH INST 

INlTIAL SUBMISSION: LETTER FROM ETHYL CORP TO USEPA RE TECHNICAL 

AND TOXICITY DATA ON BROMINATED FLAME RETARDANTS INCLUDING 

DATED 5/23/88 

Chemical 

HEXABROMOCYCLODODECANE 
Microfiche Nc. 71 o I·· 

O!"tlct OF TOxzC SUBSTANCES 

CODING FORM FOR GLOBAL INDEXING 

ll No. 

.ooe r.n. I FYI ~K7qd- """' /~·7 3 I Old Doe I.D. I 

f 

Case No.Csl 

II 

Dace Produced rf!TT 6 Date Rec'd 6 I 7 

Check One: DPublieat:l.on Otnternallv Generated 

Pub/ Journal Name 

Author sl I 

Orooo. Nalll!!-1 

De~e/Div I 

P.O. Boil 131 Street NoJNamel 

I 

Cit11:l lSI Statel 

... l6 ~ 

MID llo. 7l I 19 I D & B NO. 11 I 

I 

Cont:ractcr r 

Doc Tv~el 

• • • E.~.:b Doc Tltle I 

; 

Chemical lla.., 1300-ne= name \T 25 

. 

• 

REV. 7/27182 

of Paooa I · 2 ! 

4 

5 

Conf. Code • I 8 

tJ 

DExternallv Gene=ated 

9 

9 

10 

ll 

' 

12 

-

l4 

17 I Countrvl 16 

20 

21 

22 

_,__ 

23 

CAS No. (lOll 24 

-

. . ... . 
ETHYit CORPORATION 

Health and Environment Departme1 

ETHYL TOWER. 451 FLORIDA 

BATON ROUGE, LOUISIANA 70801 

Mr. Robert Brink 

EXecutive Secretary 

TSCA Interagency Testing 

Committee (TS-792) 

May 23, 1988 

u. s. Environmental Protect~on Agency 

401 M Street, s.w. 

Washington, DC 20460 

near Mr. Brink: 

RE: Decabromodiphenyl oxide, Octabromodiphenyl oxide, 

Hexabromocyclododecane, Pentabromodiphenyl oxide 

Ethyl Corporation is submitting the enclosed information in 

response to ITC's request for comments and data on brominated flame 

retardants. 

Ethyl is a manufacturer of decabromodiphenyl oxide {1163-19-5), 

octabromodiphenyl oxide {32536-52-0), pentabromodiphenyl oxide 

(32534-81-9), and hexabromocyclododecane (3194-55-6). For your 

information, we have enclosed the following technical and toxicity 

data: · 

1. Saytex® Flame Retardants Product List {Ethyl Chemicals 

Group). 

2. Technical Bulletins for decabromodiphenyl oxide, 

octabromodiphenyl oxide, and hexabromocyclododecane. 

3. Material Safety Data Sheets for decabromodiphenyl oxide, 

octabromodiphenyl oxide, pentabromodiphenyl oxide, and 

hexabromocyclododecane. 

4. Toxicology tests on: 

oecabromodiphen¥1.. oxide: 

o Determination of DBDPO in rat livers (5/2/80) 

o 90-day subchronic study in rats [Tracor-Jetco] 

o Comedogenicity (9/21/81) 

o Eye irritation (3/24/86) 

0 Human repeat insult patch test (6/4/75) 

0 13-week feeding study in mice (7/27/79) [Tracor-Jetco] 
Brink 

1988 

Octabromodiphenvl oxide: 

• 1-hour dus·c inhalation (1/31/841 

o Two year dietary study in rates (?) paper/Dow 

o Acute oral toxicity (12/5/83) 

o Dermal irritation (11/29/83) 

o Eye irritation (12/5/83) 

o Ames test (7/1/85) 

o Dose Range Finding Study (12/7/84) 

o Embryo/fetal toxicity (4/15/85) & Review 

Hexabromocyclododecane: 

o Arr;,s test ( 11/17/7 B) 

• Inhalation LCso/Dermal LCso (11/7/78) 

o Primar~ dermal irritation/dermal corrosion/occular 

irritation/oral LDso (10/17/78) 

Pentabromodiphenyl oxide: 

o Acute inhalation in rates (11/77) 

o Acute oral toxicity in rates (11/84) 

• Ames test (12/85) 

o Bromacnegenio (9/77) 

o Acute toxicity (9/77) 

• ·Acute oral and percutaneous toxicity (9/77) o Delayed hypersensitivity (10/77) 

o Embryo/fetal toxicity (4/15/85) 

In addition, under s~parate cover as attachment, Ethyl is 

submitting proprietary information which we are requesting the ITC to 

hold as "TSCA Confidential Business Information•. 

If you have any questions, please call me at (504l 388-7650. 

LLW/ccj 

2600r 

Sincerely, 

1./.rv~~ Louise L. Weii 

Regulatory Affairs Associate 
!/ti'ii<'AIJ.eoi'(O cyc./o.£-tik ~ ' 

.,;:\-\.~\ eo .. ~ ( ~qse) 

MUTAGENICITY TEST OF Gl.S-S6-41A 

November 17., 1978 

Tes:t: performed by Asya Shoi.cbet, Technician 

Certified by Kenneth Ehrlich, Project Supexvisor, 

Department of Cytology and Applied Biochemistry 
The sample, GLS-56-41A, was dissolved in dimethyl sulfoxide (10 

mg/ml) and r:er,ted by the Ames Salmonella/microsome test procedure [Ames, 

B.N., J. McCann, and E. Yamasaki (1975) Mutetion Res. ;!_ 347]. The test 

was performed at levels of 2 to 1000 ~g per plate and results are given 

ia the table. The number of S3lmctlella revertants obtained per plate 

can be compared to the control values~ With Salmonella strains TA1535, 

TAlOO, and TA1537 the number of revertants in sample-treated plates was 

equal to the number found for the untreated DMSO control plates. With 

TA98 tested in the presence of sample and liver homogenate, there was an 

~ncrease of 20 colonies above DMSO control for plates treated with 40, 

200, and 1000 pg ~f sample. The activity of the liver homogenate was 

~onfirmed by its ability to convert benzo(a)pyrene and 9-aminoacridine 

to mutagenic products. 

Discussion 

Reversion of ~he Salmonella histidine auxotrophs is caused by 

mutagenesis. The different Salmonella strains have differing sensitivities 

to base-pair subst~tution mutations and to frameshift mutation. Strains 

TAlOO and TA98 are particularly sensitive to most mutagenic substances 

but due to their intrinsically high spontaneous mutation frequency, 

small increases in· number of revertants compared to background levels 

must be interpreted cautiously. The fact that no dose-response reversion 

of TA98 was found, although there was a slisht increase compared to 

solvent control, may be considered evideuce that this increase is not 

due to mutagenesis. Furthermore, since the increased mutation frequency 

is less than 70 revertants more than control at the highest dose tested, 

the agent would be, at best, only an extremely weak mutagen. For these 

reasons we interpret the results to suggest that GLS-S6-41A is a nanmutagenic 

substance. 

·: .; 
!illTAGENICI"fY TEST OF GLS-S6-41A 

Revertants jzer jzlate 

pg{plate S9 TJ\98 TAlOO TA1535 TA1537 

1000 35 247 25 - 7 

+ 63 290 22. 7 

200 30 240 26 7 

+ 61 257 21 7 

40 25 234 22 6 

+ 56 260 19 8 

2 .:. 22. 218 20 6 

+ 47 242. 17 •8 

Controls 

DMSO 0.1 1>\l, + 42 234 21 10 

Benzo(a)pyrene, + 114 543 NT NT 

(5pg) 

N-methyl-N-n~troso 

N-n~troguall!idine, - NT NT 220 NT 

(Spg) 

9-aminoaC.ridine + NT NT NT 350 

(Spg) 

NT= Not tested • T<old ?{:<.<;fH I {'L,.t•... "' ;.: d:. . 

• 
··~ Consumer Product Testing 

Bldg No. 2-158 

1275 Bloomfield Avenue 

Fairfield, New Jersey 07006 

CLIENT: 

ATTENTION: 

TESTS: 

TEST 

MA1ERIAL: 

EXPERIMENT 

REFERENCE NO. : 

Date November 7, 1978 

AI.P /CAL/nlrn • 

F IN A L 

Company _Incorporated 

(2011 575-7688 

(2011 575-7669 

REPORT 

Saytech Inc. 

880 ~lain Street 

_sayreville, Ne1< Jersey 08872 

LaVerne J. Makfinsky 

Manager, Technical Compliance 

Inhalation tc50 (Rat) 

Dermal to50 (Rabbit) 

GLS-S6-41A 

78385-2 

('Jr. 1...\.-:} tL-tL~ ./ r.J:_,: (..(. _, Christine A. Lewis, B.S. 

Laboratory Supervisor 

Project Directo~ 

IJ {_ !l/7 .. // 

I c. . . . t c., ·-' .r~ t'c< ~ .. Le------ Al len L. Palanker • 

President 

. . ·.: 

This repariiS submnted for the eXclu:Siv~ uSe of ule pets on, Partriershfp. or.Cor~mti~n to~lto"m ii'i~ add;~ssed:~~d ~~ith~~:ihe ~~~i':'::-:i·. nor I he name of these Loborittorles no.rofilnymP.mber of iis stein -may be uSedincoful"eCilonwlih theadveruslriQ'O;. ffiilenf'an\fpf'oduct : .·-~-" 

Mf'""'"""'"'"·'~'i""' :"~'".~--"~::,··.~;~,;:.:~; !" , ., , -.:: :·; • :-,,,;· ; \';·.; _.·,.,, ·::;·;:.··. ~ '- .,•,:;·~::~··:;":~·:.:.:'.:5:~:,:.:.•":~:..;_.,~-:i~ 
This report details : 

a dermal LD50 study in albino rabbits and 

an inhalation LC50 study in albino rats 

performed at the behest of : 

Saytech Inc. 

880 Main Sneet 

Sayreville, New Jersey 08872 

The test material, supplied by : 

Saytech Inc. 

was received on : 

September 15, 1978 

and identified as : 

GLS-S6-41A 

and was used as indicated in the Final Report Summaries. 

Study Interv?J : September 28, 1978 to November 2, 1978 

All a,nimals are fed and watered ad libitum; with Wayne animal feeds used exclusively. Animals are received from Summit VIew Farm, Belvidere, New 

Jersey and are conditioned prior to use. Samples, raw data and final report copies 

are retained at these laboratories unless otherwi~e indicated. 

Project Director and study supervisor are signatory to this report. Date of submission is recorded on title page. Names ol persons performing these tests are 

recorded on raw data sheets and laboratory log books and are available upon request.. 
Range 

Final Report Summary 

DATE: November 7 •. 1978 

CLIENT: Saytech Inc. 

STUDY NO.: 78385-2 

REFERENCE NO.: P. o. #00323 

MATERIAL: GLS-S6-41A 

Acute Dermal Toxicity {LD5al 

Method: Follo.,ing 14-day range finding, albino rabbits in groups of six 

(3N:3P), lj abraded, 1.88 - 2.07 kg, highest dose level mechanically 

possible, single application dermally under occluded patch, ob~ 

se:rved fourteen days. Natei·ial used as received .. LD50 and 95% 

confidence limits according to the method of Litchfield and Wilcoxin, 

when possible. Upper limit possible due to mechanical and physical 

limitations is 8 g/kg. 

Result: LD50' > 8 g/kg 

Dose Level 

(g/kg} Sex l!dead/1/dosed %Mortality 

o.s lF 0/l 0 

Finding: 2.0 lF 0/1 0 

Test 

Dosage: 

5.0 lF 0/1 0 

8.0 lF 0/1 0 

8.0 3M:3P 0/3:0/3 0 

Not a toxic material dermally to rabbits under conditions of 

this test. 

Consumer Product Testing Company, Inc. . ' . ' - ' ·' 

. ~- ' . 
Final Report Summary 

DATE: November 7, 1978 

CLIENT: Saytech Inc. 

STUDY NO.: 78385-2 

REFERENCE NO.: P. 0. 1100323 

MATERIAL: GLS-S6-41A 

Inhalation Lc50 

Method: Albino rats in groups to ten (SH:SF), 233-292 g, 

concentrations of 200 m&/liter (highest possible 

concentration) for one hour~ observed two weeks. 

used as received. 

Result: Lc50 > 200 mg/1 

Gross 

Dose Level 

(mg/1) 

200 SM:SF 

Pathology: No gross changes observed. 

#dead/Udosed 

0/5:0/5 

exposed to 

chamber 

Material 

% 

0 

Not a toxic material by inhalation to rats under conditions 

of this test. 

Consumer Product Testing Company, Inc. 
METHOD: Acute Dermal ToXicity in Rabbits (LD 50) 

Saytech Inc. 

78385-2 

·Page 5 

Acute dermal toxicity in rabbits was dete'imined 

according to 1he procedures suggested by Hagan: New 

Zealand white. rabbits, as indicated in the summary, 

were maintained under standard laboratory c;onditions prio~ to administration of the test material. 

Prior to determination of l D 50 single animals, skin unabraded, were dosed at various levels to determinl! a 

range within which the LD 50 could be determined. 

Animals were observed fourteen full days following 

application to determine mortality during this period. 

Following the range finding t!ie rabbits were dosed 

individually by dermal application under occluded patch 

at a dose level according to the results of the 11!--day 

range finding previously performed. Applications were 

made to the clipped backs of six (3M:3F) animals, 1/2 

abraded, under I" x 1" gauze patches over 10% of the 

body surface. The dosed area was then covered with an 

impermeable plastic wrapping for 21!- hours, after which 

it was removed and the skin gently cleansed. Animals 

were returned to quarters where food and water were 

available ad libitum following the dose application. 

Animals were observed for signs of pharmacologic 

activity and drug toxicity at 1, 3, 6, and 24 hours postdosage. Observations were made daily thereafter to a 

total of fourteen days. 

Non-surVivors and animals sacrUiced at the end of the 

14-day observation period were subjected to complete 

gross necropsy. LD together with 95% confidence 

limits was determineJ, ~here possible, by the method of 

liti:hfield and Wllcoxin. 

The highest dose mechanically feasible to use is 

considered to be 8 g(ml)/kg bodyweight. Doses as high 

as 20 g/kg are used when instructed under EP/1. 

regulations; however, the data derived at, at these 

extraordinary high levels cannot be deemed as accurate 

as that derived at, at the lower dose levels. 

1

Hagan, E.C. (1959) /\.cute Toxicity; Appraisal of the Safety of Chemicals in Foods, 

Drugs, and Cosmetics, pp. 17- 25. 

2Litchfield, J.T. and Wilcoxin, F. (1949) Acute Toxicity; J. Pharm. & Ex. Ther•, pp. 96, 

99. 
Inhalation LCao in Rats 

Saytech Inc. 

7S3SS-2 

-Page 6 

A group of adult Wistar-derived albino rats as 

indicated in the summary 1 was housed in a threecubic-foot plastic chamber for the single one (I) hour 

dynamic exposure pedod. The chamber was initially 

charged with test material at a concentration of 200 

mg/1. Preconditioned supportive air was supplied at 

five (5) liters per minute, and the test material was 

presented from a dust generator to continue a 

nominal chamber concentration of 200 mg/llter alr, 

over the one hour period. 

At the end of the one~hour period, the animals were 

returned to individual quarters and observed daily for 

two weeks after which time they were sacrificed and 

autopsied. 
RESULTS: Acute Dermal Toxicity in Rabbits 

Saytech Inc • . -78385-2 

Page 7 

I~dividual results are presented in Tables 1 & 2. 

Acute Inhalation Toxicity 

Individual results are presented in Table 3. 

Summaries of all results are found preceding the text. 
Range 

Find in 

Dose Animal Number 

g/kg and Sex 

Table 1 

Acute Dermal Toxicity in Rabbits 

GLS-S6-41A 

Bodyweight Hours: Days: 

(kg) I 3 6 21! 2 3 

1.95 N N N N N N 

2.03 N 

4 5 

N N 

6 

Saytech Inc. 

78385-2 

-page 8 

Bodyweight 

7--14 (kg) 

N N N 2.11 

2.36 

0.5 

2.0 

5.0 

8.0 

1F 

2F 

3F 

4F 

1.94 N NO CHANGES OBSERVED 2.28 

a = abraded skin 

N =Normal 

D = Depression 

SD =Slight Depression 

XD = Severe Depiesslon 

+ = Animal Death 

2.25 N 

Comments: Animal #1 - #4: Skin pliable and non-h:ritated. No gross 

changes observed. 

Draize Scores at 24 Hours: Animal #1 0/0 

Animal #2 0/0 

Animal #3 0/0 

Animal #4 0/0 

2.51 
Dose Animal Number 

g/kg and Se>< 

8.0 !M 

2M a 

3 Ma 

4F 

5Fa 

6F 

a = abraded skin 

N =Normal 

D = Depression 

SD =Slight Depression 

XD = Severe Depression 

+ = Animal Death 

Table 2 

Saytech Inc. 

78385-2 

Page 9 

Acute Dermal Toxidty in Rabbits 

Bodyweight 

(kg) 

1.98 

1.88 

1.98 

2.00 

2.07 

2.06 

GLS-S6-41A. 

Hours: Days: . Bodyweight 

I 3 6 21; 2 3 It 5 6 7--14 (kg) 

N N N N N N N NN N N 2.52 

N 2.38 

N ~0 CHANGES OBSERVED 2.42 

N 2.06 

N 2.19 

N 2.69 

~onunents: Animal Ul ·• #6: No gross changes observed. 

Draize Scores at 24 Hours: Animal #1 0/0 

A.nimal #2 0/0 

Animal #3 0/0 

Animal Y4 0/0 

Animal #5 0/0 

Animal #6 0/0 
Table 3 

Acute Inhalation Toxicity 

GLS-56-41A 

Dose Animal Number Bodyweight Hours: Days: 

mg/1 and Sex (grams) I 3 6 24 2 3 

200 IM 284 N N N N N N 

2M 292 N 

3M 274 N 

4M 264 N 

4 5 

N N 

Saytech Inc. 

78385-2 

·page 10 

Bodyweight 

6 7-!11 (grams) 

N N N 366 

344 

330 

320 

5M 270 N NO CHANGES OBSERVED 284 GF 

7F 

8F 

9F 

10 F 

N =Normal 

D = Depression 

SD = Slight Depression 

XD = Severe Depression 

+ = Animal Death 

282 N 

242 N 

233 N 

244 N· 

242 N 

Cornmentsj Animal "1 - DlO: No gross changes observed. 

370 

278 

268 

2i6 

268 
Consunter Product Testing 

Bldg. No. 2-156 

1275 Bloomfield Avenue 

Fairfield, New Jersey 07006 

Company Incorporated 

(201) 575-7688 

(201) 675-768!) 

F I N A L R E P 0 R T 

CLIENT: 

ATTENTION: 

TESTS: 

TEST 

MA:fERIAL: 

EXPERUIENT 

REFERENCE NO. : 

Date October 17, 1978 

CAL/nlrn 

Saytech Inc. 

880 Main Street 

Sayreville, New Jersey 08872 

LaVerne J. Makfinsky 

Manager, Technical Compliance 

Primary Dermal lxri tat ion (Rabbit) 

Dexrnal Corrosion (Rabbit) 

Ocular Irritation (Rabbit) 

Oral LDso (Rat) 

GLS-S6-41A 

78385-1 

Christine A. Lewis~ B~S .. 

Laboratory Supervisor 

Project Director 

~{fv.1r j. /l~Y,~ Allen L. Palanker 

President 

This report iS sUbmiUed for the exclusive use of the p(:rson, Partnership, or corpara~lo n tO who~ it is addreSSed. ~d:n'uillt~'r tti~ ~; :· nor the n~,m~t these Laboratorie-s nOr of anymemberofitsslaff. maybe used m ccinnectiori.tNilti ttie advertising Orsai&OtB'nVP'rodUe1: -5 ··~ ... :~ ........ ~---.a"'-"'';,· .. :.~-~ ..... -~~--:--.:,:~.·. ·' . •, . . . ·.. ·---,:_·· .. •',• '•• .. ·.-.. ~ _., .... , .. 
This report details : 

a primary dermal irritation study, 

a dermal corrosion study, and 

an oculac irritation study in albino rabbits and _ an oral LDso study in albino rats 

performed at the behest of : 

Saytech Inc. 

880 Main Street 

Sayreville, New Jersey 08872 

The test material, supplied by : 

Saytech Inc. 

was received on : 

September 15, 1978 

and identified as : 

GLS-S6-41A 

and was used as indicated in the Final Report Summaries. 

Study Interval : September 25, 1978 to October 13, 1978 

All animals are fed and watered ad libitum; with Wayne animal feeds used 

exclusively. Animals are received from Summit View Farm, Belvidere, New 

Jersey and are conditioned prior to use. Samples, raw data and final report copies 

are retained at these laboratories unless otherwi~e indicated. 

Project Director and study supervisor are signatory to this report. Date of 

submission is recorded on title page. Names of persons performing these tests are 

recorded on raw data sheets and laboratory log books and are available upon 

request. 
Final Report Summary 

DATE: October 17, 1978 

CLIENT: Saytech Inc. 

STUDY NO.: 78385-1 

REFERENCE NO.: P. 0. 1100323 

MATERIAL: GLS-S6-41A 

Prini.~ry Derma! irritation 

Method: Six rabbits, mixed sex, each abraded and non-abraded, 0.5 ml single 

application under occluded patch, 24 and 72 hour observation. Material 

used as received. 

Result: Primary Irritation Index:* 

o.o 

Not a primary dermal irritant to rabbits under the conditions of this test. 

* See Table 1 A for evaluation. 

:: .... ' 

· · consumer Prod~i:t 1'i.ititlg co'mpariy, rile:: : . >::' ::-:::, .. ,_·f~:: :.:,::~::;' . ·-~ ··;!,_:·:·}(.:i_~i::-::~:;:.'>. ·. '': ::; :·:.::: ~- ,_-.--~-- 'i~:;: 
Final Report Summary 

DATE: October 17, 1978 

CLIENT: Saytech Inc. 

STUDY NO.: 78385-1 

REFERENCE NO.: P. 0, #00323 

MATERIAL: GLS-S6-41A 

Dermal Corrosion 

Method: Six rabbits, mixed sex, each non-abraded, 0.5 ml single application 

under occluded pate~, ~and 48 .. hour observation. 

Material used as received. 

Result: Prima:ry Irritation Index: 0.0 

Corrosive: 

lf9 CFR 173.240 (a)(!): 

IS 

IS NOT X 

Consumer Product Testing Company, Inc. 
Final Report Summary 

DATE: October 17, 1978 

CLIENT: Saytech Inc. 

STUDY NO.: 78385-1 

REFERENCE NO.: P. o. #00323 

MATERIAL: GLS-S6-41A 

Ocular Irritation 

Method: Six rabbits, mixed sex, 1.8- 2.4 kg, 0.1 ml single administration, all with no wash for 24 hours and up to seven day observation. Material used as received. · 

Result: Draize Score 

-----Day-------

1 2 :3 4-·--7 

No Wash 6.2 2.8 0.3 0 

Mild~ transient ocular irritant in rabbits under the 

conditions of this test. 

Consumer Pro~uct·Testing cofiipa_,;y ,•Jrii:_ . .-... ···· . . . ·-··' •'.•;' _,, .. , ... ' '· ... ;· ··.·,· .. :." ···: 
Final Report Summary_ 

DATE: October 17, 1978 

CLIENT: Saytech Inc, 

STUDY NO.: 78385-1 

REFERENCE NO.: P. 0. «00323 

MATERIAL: GLS-S6-41A 

Oral LD50 

Method: Albino rats in groups of ten (5M:5F), 192- 260 g, single dosed orally, 

(40 ml/kg top dose mechanically feasible) observed fourteen days. Material 

used as a 25% gravimetric suspension in corn oil. 

Result: 

Range 

Finding: 

Test 

Dosage: 

LD 50: > 10 g/l:g 

Dose Level 

(g /kg) Sex fldead/lldosed ~ 

1.0 1M 0/1 0 

3.0 1M 0/1 0 

s.o HI 0/1 0 

10.0 1M 0/1 0 

10.0 SM:SF 1/5:0/5 10 

Not a toxic material orally to rats under the conditions of 

this test. 

Consumer Product Testing Company, Inc. 
METHOD: 

Saytecb Inc. 

78385-1· 

Page 7 

Primary Dermal Irritation in Rabbits 

A group of albino New Zealand rabbits as 

indicated in the summary were used in this study. 

The tpst method was essentially that of Draize et.al. . 

Briefly paraphrased, it consisted of application of 0.5 ml (0.5 g) of the test material to dipped 

areas of intact and abraded skin. The abrasions 

were longitudinal epidermal incisions sufficiently deep to 'penetrate the stratum corneum, but not 

so deep as to destroy the integrity of the derma. 

Applications were made under occlusive patches 

(211 x 211 gauze, CO\'ered by adhesive tape). 

Following application of the test material the 

entire trunk of each animal was covered with an 

impermeable occlusive wrapping. The availability of the test site to the animal is restricted 

by use of everted Elizabethan collars. The 

wrapping and test material were removed 2l/. 

hours following application. The sites were 

individually examined and scored separately for 

erythema and edema at 24 and 72 hours. The 

mean scores for 24 and 72 hour gradings were 

averaged to determine final irritation indices. 

· 

1

Draize;, John H., Woodward, Geoffrey, and Calvery, Herbert· o,, "Methods for 

the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", J. Pharm. lt. Ex. Ther. 82, 377, (1944); ··, · ·• ' . 

.' ~'.: : 

'·,i: ··:-: ·.. -~ .. \ 
Dermal Corrosion in Rabbits 

49 CFR 173.240 (a)U): 

Sayt:ech Inc. 

78385-1 

Page il 

A group of six (6) albino New Zealand rabbits in a 

weight range of 1.8 - 2.4 kg, were used in this 

study. The test method was essentially that of 

Draize et.al. 

Bdefly paraphrased, it consisted of application 

of 0.5 ml (0.5 g) of the test material to clipped 

areas of intact skin. Applications were made 

under occlusive patches (2'1 x 211 gauze, covered 

by adhesive tape). Following application of the 

test material the entire trunk of each animal was 

covered with an impermeable occlusive 

wrapping. The animals were then immobilized. 

The wrapping and test material were removed 4 

hours following application. The sites were 

individually examined and scored separately for 

erythema and edema at 4 and 48 hours. The 

mean scores for 4 and 48 hour gradings were 

averaged to determine final irritation indices. 

Corrosiveness seen at four and/or 48 hours alone 

indicates a corrosive material. Tissue 

destruction (corrosiveness) does not include 

merely sloughing of the epidermis, or erythema, 

edema or fissuring. 
Saytech Inc. 

78385-1 

Page 9 

Primary Eye Irritation in Rabbits (FHSA) 

New Zealand rabbits as indicated In the summaty without ocular defects were used. The procedure followed was a modification of that used by Dr. J.H. 

Draize in Appraisal of The Safety of Chemicals in 

Foods, Drugs and Cosmetics, compiled by the staff 

of the Division of Pharmacology, Food and Drug Administration - Department of Health, Education 

and Welfare. ·· 

In the technique of determining toxicity of substances to eye mucosa, observations of injuries were 

made ~n the cornea, iris and the bulbar and 

palpebral conjunctivae. Numerical scores were 

assignep to lesions observed according to the 

Draize standard scoring system. In this system of 

scoring, the injuries to the cornea and iris account 

for approximately eighty (80%) percent of the total 

score; tliese structures · are purposely weighted 

because of their vital role in vision. Healthy New 

Zealand rabbits were used for this test. One-tenth 

of a milliliter of each test substance was instilled in 

the right eye; the left eye, rem~ining untreated, 

served as a control. The treated eyes of all rabbits 

remained unwashed for 24 hours. 

Readings facilitated by hand-held lenses were made 

1, 21 and 3 days after treatment, and up to seven (7) 

days when necessary. 

1

Dralze, John H., Woodard, Geoffrey, and C<i!very, Herbert o., i•MethodS for the 

Study of Irritation and Toxicity of Substances Applied Topically t~ the Skin and 

Mucous Membranes", J. Pharm. &: Ex. Ther. 82, 377; (1941fl.. ·. .. · . . . . 
Acute Oral Toxicity in Rats (!.0 50> 

Saytech Inc. 

78385-1 

Page 10 

Acute oral toxicity in rats was deterj"ined according to the procedure suggested by Hagan. Wlstar-derived 

albino rats, as indicated in the summary were 

assigned to groups, and maintained under standard 

laboratory conditions for a minimL:m of seven days, and fasted overnight prior to adni'i,\istratlon of the 

test material. 

The rats were dosed individually by gavage, at graded dose levels (following range finding) after which they 

were returned to quarters where food and water were 

available ad libitum. 

Animals were observed for signs of pharmacologic activity and drug toxicity at I, 3, 6 and 2~ hours post- dosage. Observations were made daily thereafter to 

a total of four.teen days. 

Animals sacrificed at the end of the 14-day observation period were subjected to complete gross 

necropsy. 

I.D50 was calculated, (including the 9.5% confidence 

limlt:s) wher'Zpossible, using the method of Litchfield 

and Wilcoxin except when the highest maximum dose 

mechanically possible (lfO ml/kg) is used, 

1

Hagan, E.C. H9.59) Acute Toxicity; Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, pp. 17 - 2.5. 

2

Litchfield, J. T. and Wllcoxin, F. (1949) J, Pharmacal. Exptl~ Therap. pp. 96; 99, 
RESULTS: 

Saytech Inc. 

78385-1 

Page 11 

Primary Dermal Irritation and Dermal Corrosion in Rabbits 

The scoring scale used is presented in Table 1. The individual results axe px·esented in Tables 2 

and 3. 

Primary Eye Irritation in Rabbits 

T~l:lle 4 detajls Scoring criteria. The individual 

results are presented in Table 5. 

Oral tn50 in Rats 

Individual results are presented in Tables 6 and 7. 

Summaries of all results are found preceding the 

text. 
Saytech Inc. 

78385-1 

Table 1 

Scoring Criteria for Skin Reactions 

Erythema and Edema Formation 

Very slight erythema (barely perceptible) 

Well-defined erythema 

Moderate to severe erythema 

Severe erythema (beet redness) to slight eschar 

formation (injuries in depth) 

Total possible erythema score = 4 

Edema Formation 

Page :12 

{J-· 

1 

2 

3 

4 

Very slight edema (barely perceptible) l 

Slight edema (edges of area wellcdelined 

by definite raising) 2 

Moderate edema (area raised approximately I mml 3 

Severe edema (raised more than I mm and extending 

beyond area of exposure) 4 

Total possible edema score = 4 

Total possible primary irritation score = 8 

;., ... · 
Score 

c 

.5.0 and above 

3.0 • 4.9 

2.0- 2.9 

1.0 -1.9 

0.1- 0.9 

o.o 

Table iA 

Scale of Interpreting 

Primary Dermal Irritation Scores 

(Draize- Rabbit) 

Interpretation 

Saytech Inc. 

78385:1 

Page 13 

Corrosive- highly dangerous, warning labels must 

be used 

Primary Dermal Irritant .. highly dangerous, warning 

label must be used 

Potential tOr severe irritation ~ warning ~abel would 

be advised · 

Potential for moderate irritation- may be irritating 

to humans under conditions similar to test (may consider 

warning label) 

Potential for mild irritation- possibly irritating to 

some people under occlusive wrap conditions - usually 

no warning required 

Potential for slight irritation- rarely irritating to 

people -no warning required 

No irritation potential- no warning required 
Table 2 

Primary Skin Irritation - Rabbits 

SUMMARY OF SCORES FOR SKlN IRRITATION 

GLS-S6-41A 

Rabbit Hours: 1 2~ 

Number Skin .E I Ed E 

1 NA2 

0 0 0 A:; 0 0 0 

2 NA 0 0 0 

A 0 0 0 

3 NA 0 0 0 

A 0 0 0 

4 NA 0 0 0 

A 0 0 0 

s NA 0 0 0 

A 0 0 0 

6 NA 0 0 0 

A 0 0 0 

Average NA 0.0 o.o 0.0 

A o.o o.o 0.0 

Saytech Inc. 

78385-1 

Page i4 

72 

I Ed 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0.0 

0.0 

Combined Averages: 0.0 

Primary Irritation Index: 0.0 

IE/Ed= Erythema and Edema 

2NA =Non-abraded skin 

3 A = Abraded S~.in 
Table 3 

Primary Skin Irritation - Rabbits 

SUMMARY OF SCORES FOR SKIN IRRITATION 

GLS-S6-41A 

Rabbit Hours: 

El 

4 4& 

Number Skin I Ed E I 

1 NA2 0 0 0 

2 NA 0 0 0 

3 NA .0 0 0 

4 NA 0 0 0 

5 NA 0 0 0 

6 NA 0 0 0 

Average NA 0.0 0.0 0.0 

Combined Averages: 

Saytech Inc. 

78385-1 

Page 15 

Ed 

0 

0 

0 

0 

0 

0 

o.o 

0.0 

Primary Irritation Index: 0.0 

1 E/Ed = Erythema and Edema 

2NA = Non-abraded skin 
Ocular 

Tissues 

Cornea 

Iris 

Say tech Inc. 78385~1 

Table 4 

Eye Irritation Test 

Scale of Weighted Scores for 

Grading the Severity of Ocular Lesions 

Page 16 

Description Grading 

Opacity (A) 

Opacity- degree of density (area which is dense is taken for 

reading) 

Scattered or diffuse area, details of iris dearly visible. I 

Easily discernible translucent areas, details of iris slightly 

obscured. 2 

Opalescent areas, no details of iris visible, size of pupil 

barely discernible. · 3 

Opaque, iris Invisible. 4 

Area of Cornea Involved (B) 

One-quarter (or less), but not zero, 

Greater than one-quarter, but less than one-half. 

Greater than one-half, but less than three·-quarters. 

Greater than three-quarters, up to whole area. 

I 

·2 

3 

4 

Score equals A x B x 5 Total maximum = 80 

-'ES:r:-::C ... _ rlormal, congestion, swelling, circumcorneal 

Injection or all of these or combinations of any thereof), 

iris still reacting to light. 

Sluggish reaction is positive. I 

No reaction to light hemorrhage, gross destruction, 

(any or all of these). 2 

Score equals A x 5 Total maximum = 10 
Ocular 

Tissues 

Conjunctivae 

Saytecli Inc, 

78385=1 

Table 4 (cont'd.) 

Eye Irritation Test 

Scale of Weighted Scores for 

Grading the Severity of Ocular Lesions 

Page 17 

Description Grading 

Redness (A) 

Redness (refers to palpebral conjunctivae only). 

Vessels definitely injected above normal. 

More diffuse, crimson red, individual vessels not 

easily discernible. 

Diffuse beefy red. 

Chemosis (B) . 

I 

2 

3 

Any swelling above normal (includes nictitating 

membrane). I 

Obvious swelling with partial eversion of the lids. 2 

Swelling with lids about half-closed. 3 

Swelling with lids about half-closed to completely 

closed. II 

Discharge (C) 

Any amount different from normal (does not include 

small amount observed in inner canthus of normal 

animals). 1 

Discharge with moistening of the lids and hairs just 

adjacent to the lids. 2 

Discharge with moistening of the lids and hairs and 

considerable area around eye. 3 

Score equals (A + B + C) x 2 Total maximum = 20 

Notei The maximum total score is the sum of all scores obtained for the cornea, iris 

and conjunctivl!e. · ;;; 
Saytech Inc. 

Table 78385.-1 

5 Page 18 

Primary Eye Irritation- Rabbits 

SUMMARY OF EYE IRRITATION 

GLS-S6-41A 

Rabbit Cornea: Iris: Conjunctivae: Total 

Number Day AxBx5+ A X 5 + (A+B+C)xZ= Scores* 

--··--------.. -----No Wash Group---------------

1 1 0 0 0 (B) 1 0 0 2 

z 0 0 0 1 0 0 2 

3 0 0 0 0 0 0 0 

4 

7 

2 1 0 0 0 0 0 0 0 

z 0 0 0 0 0 0 0 

3 0 0 0 0 0 0 0 

4 

7 .· .. ; 

3 1 0 0 0 (B) 1 1 0 4 

z 0 0 0 0 0 0 0 

3 0 0 0 0 0 0 0 

4 

7 

4 I 0 0 1 (B) 1 1 1 11 

z 0 0 0 l 1 0 4 

3 0 0 0 0 0 0 0 

4 

7 

5 1 1 1 1 (B) 2 2 1 20 

z 1 1 0 1 I 1 11 

3 0 0 () 0 1 0 2 

4 0 0 0 0 0 0 0 

7 

6 1 0 0 0 0 0 0 0 

2 0 0 0 0 0 0 0 

3 0 0 0 0 0 0 0 

4 c - 7 

Average I 6.2 

2 2.8 

3 0.3 

4 0 

7 

*Total score possible/animal/observation interval= 110 

(B) = ,Blanched .. 

.: : ::;· ;·~·> -

·; .. :;"_, ..... . . 

;.:·' '··:. '• .. ... :· ;:. .... ·._, . -
Range 

Finding 

Dose Animal Number 

g/kg and Sex 

1.0 

3.0 

5.0 

10.0 

N =Normal 

1 M 

2 ~I 

3 ~I 

4 M 

D = Depression 

SO = Slight Depression 

XD = Severe Depression 

+ = Animal Death 

Table 6 

Acute Oral Toxicity 

GLS-56-41A 

SaYtech Inc. 

78385-1 

Page 19 

Bodyweight Hours: Days: Bodyweight 

(grams) 1 3 6 24 2 3 .4 5 6 7-14 (grams) 

234 

240 

250 

260 

N N N N N N N N N N N 348 

N 316 

N NO CHANGES OBSERVED 340 

N MO 

Comments: Animal #1 - #4: No gross changes observed. 

,. :·-: '";. ~··· ' 
Table 7 

Acute Oral Toxicity 

Qose Animal Number 

g[kg and Sex 

10.0 IM 

2M 

3M 

4M 

5M 

6F 

7F 

8F 

9F 

10 F 

N =Normal 

D = Depression 

SO = Slight Depression 

XD = Severe Depression 

+ = Animal Death 

Bodyweight 

(grams) 

200 

202 

212 

254 

250 

194 

192 

200 

194 

200 

* = Hair moist, matted at 2 days 

GLS-S6-41A 

Hours: 

1 3 6 2/f 

N N N N 

N N N N 

N N N N 

N N N N 

N N N N 

N N N N 

N N N N 

N N N N 

N N N N 

N N N N 

Days: 

2* 3 4 5 

NN N N 

NN N N 

NN N N 

NN N N 

NN N N 

NN N N 

NN N N 

NN N N 

N N N N 

NN N N 

Saytech Inc. 

78385cl 

Page 20 

Bodyweight 

6 7 [4 (grams) 

N N N 310 

N N N 334 

+ 180 

N N N 352 

N N N 402 

N N N 268 

N N N 252 

N N N 286 

N N N 264 

N N N 258 

Comments: Animal #1, #2, #4 - #10: No gross changes observed. 

Animal #3: Fibrous tissue encasing heart and lungs. 
PEACE OF MIND: SAYTEX" PERFORMANCE TESTED BROMINATED FLAME RETARDANTS 

PRODUCT NAME CHEMICAL NAME CHEMICAL STRUCTURE APPEARANCE %Br TYPICAL DENSITY T~A ("Cat X% wt.loss) !sOLUBILITY (gl100g, 23"CII NOTES FORM tmronnn:.tu PROPERTIES '"'"' ... ,: ~ .. ~ ~ ~ \iiMtll : /.C:HOI~ i IA:IIWQ.; lOU..IEI.I: I 

REACTIVE FlAME RETARD\NTS 

SAYTEX RB-49 T£TfiAB!lOMO l'tffiiAUCNtH't'DfliDE 

:~ 

"""' """"'" " mJ"CIJP ,., '" "' 219 - : 311 "" .w i 2.5 ___ :_ 2.!1 .. 

' . "' : """' SAYTEXRB-79 OIESTE~IEll ·~··-~ ""'" O:OLOfSAYTEXR0·(9 ~-~ir-c'C 

C. .. o-01 """" "' <.!10 107 "' '" "' '"' ,..,. OS<TY "' 
ETHYL FLAME RETARDANT 

L\PPLICATION MATRIX 

APPLICATION ~£.JJ;JkJJ~~~~~~/ ' 

-

SOLID THERMOPLASTICS 

ABS 

POLYSTYRENE (HIPS) 

NYLON 

POLYESTER (PBT/PET) 

POLYC'.ARBONATE 

POLYPROPYLENE 

POLYETHYLENE 

THERMOPLASTIC ELASTOMER 

THERMOPLASTIC POLYURETHANE 

FOAMS 

EXPANDED POLYSTYRENE 

RIGID POLYURETHANE 

FLEXIBLE POLYURETHANE 

WIRE AND CABLE 

SILICONE 

PVC 

EPDM 

SYNTHETIC RUBBER 

HIGH PERFORMANCE JACKETS 

THERMOSETS 

EPOXY 

PHENOLIC 

UNSATURATED POLYESTER 

MOD ACRYLIC FIBERS 

ADHESIVES AND COATINGS 

TEXTILES 

PAINTS 

HOT MELT ADHESIVES 

o =Reactive 

11 ==Additive 

) 

0 

0 

,, 0 ,,_,~~ 

'' 

" 

• • 

I 

0 

• 

• 

0 0 

0 0 

0 

• • 

0 

• 

0 0 

• • 

0 

" 

" .. .. " • 

• • .. .. • .. • • 0 • 

0 " II e 

• • .. .. . .. .. .. ., .. . •I• 

• " " • • 0 • • 

I 

" . . " 

0 • 

. .. " " 

. " • • . " .. 

. " 

• • " • 

• • • 

• • • • 

0 

. .. 

• 0 

c • 

• e 

0 

·: . . ~ . :.; ': 
OFFICES 

SALES: 

Ethyl Corporation 

Chemicals 

Group 

Bromine Chemicals Division 

Ethyl Tower 

451 Aorlda Boulevard 

Baton Rouge, LA 70801 

Telephone: 504-38B-8609 

800-526-3658 

Telex: 586431 ETHYL TWR 8TA 

Telecopier: 504~388-7686 

504-:388-7687 

Ethyl SA 

523 Avenue Louise, Boite 19 

B-1050 Brussels, Belgium 

Telephone: (32) (2) 642-4411 

Telex: 84622549 

Telecopler: (02) 648 43 36 

Saytex Aame Retardants 

Europe 

Ethyl Corporation 

Goldlay House 

114Parkway 

Chelmsford. EssexCM27PP 

Telephone: (44) (245) 287·577 

Telex: 995652 ETHL BR G 

Latin America 

Ethyl Chemicals, Latin America 

451 Florida Boulevard 

Baton Rouge, LA 70801 

Telephone:504-388-7460 

Telex: 586431 or 441 

Far East 

Ethyl Corporation 

Bromine Chemicals Division 

Ethyl Tower 

451 Florida Boulevard 

Baton Rouge, LA 70801 

Telephone: 504-388·7234 

Telex: 586431 ETHYL TWR BTR 

Telecopler: 604-388-7886 

504-388-7087 

TECHNICAL: 

Ethyl Technical Center 

Halogens and Fine Chem, 

8000 G.S Rt Avenue 

Baton Rouge, LA 70820 

P.O. Box 14799 

Baton Rouge, LA 70898 

Telephone: 504-?68-5964 

Telex: 7645B~ETC·BTR 

Telecopler:_504-768·5607 

The lnlorrnalion presenledhem!n is believed to be accurate and reliable. ~Is ~eseoted wfthOUI guarantee or ra sponsibllityonltle pal'lofEthyl 

CorporatiOn. Furlher. oolhing conlainad shall be 

taken as an inducement or recommendatiOI'I to manutaeture o.r usc any Ot tne herein descrobed 

ma1e~9 or pro't;nsse.c II'J Viola\!~ 'of existing or futuro patents. ~·. · ·. · · · 

'·: 

'' 

: ::·Prlrue~~;~:~! . ··,'·,.:, ·.:: . ' ' -
... 

c:c 

z 

-II. 

1&1 

a: 

c:c 

en 

1&1 

... 

:J 

... 

... 

c:c 

• Reproduced by N I ZS 

National Technical Information Service 

Springfield, VA 22161 

This report was printed specifically for your order 

from nearly 3 million titles available in our collection. 

For economy and efficiency, NTIS does not maintain stock of its 

vast collection of technical reports. Rather, most documents are 

custom reproduced for each order. Documents that are not in 

electronic format are reproduced from master archival copies 

and are the best possible reproductions available. 

If you have questions concerning this document or any order 

you have placed with NTIS, please call our Customer Service 

Department at 1-888-584-8332 or (703) 605-6050. 

About NTIS 

NTIS collects scientific, technical, engineering, and related 

business information-then organizes, maintains, and 

disseminates that information in a variety of formats- including 

electronic download, online access, DVD, CD-ROM, magnetic 

tape, diskette, multimedia, microfiche and paper. 

The NTIS collection of nearly 3 million titles includes reports 

describing research conducted or sponsored by federal 

agencies and their contractors; statistical and business 

information; U.S. military publications; multimedia training 

products; computer software and electronic databases 

developed by federal agencies; and technical reports prepared 

by research organizations worldwide. 

For more information about NTIS, visit our Web site 

at http://www.ntis.gov. 

• NTIS 

Ensuring Permanent, Easy Access to 

U.S. Government Information Assets 
<JCfOF"o 

l~ '?it ..,.,, 

. 

" ~. ' " ~~ ",/ ..,.,.., of¥ 

US DEPARTMENT OF COMMERCE 

Technology Administration 

Nanonol Technicollnformonon Service 

Splingfield, VA 22161 (703) 605·6000 

111111111111111111111111111111111111111111111111111111111111 

1111111111111111111111111 

SIN: M30 06-27-07 

INVOICE: 1661132 

SHIPTO: 1*979361 

PAYMENT: CSH*V 

===================================================~ 

I