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OTS0522235 N 

One Source. One Search. One Solution. 

GENETIC TOXICOLOGY SALMONELLA/MICROSOMAL 

ASSAY ON HEXABROMOCYCLODODECANE WITH COVER 

LETTER DATED 030890 

01 JUL 1985 

n\oadin9··· DoW 

- U.S. Department of Commerce 

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CODING FORM FOR SAC INDEXING REVISED 10115/SS 

OTS0522235 

GENETIC TOXJCDLOGY SALMOt<ELLA/MICROSOMAL ASSAY ON 

HEXABROMOCYCLODODECAr<E Wl TH COVER LETTER DATED 0308'3(1 

HEXABROMOCYCLODODECANE !3194-55-5> 
• 

' f CONTAINS NO C61 

ETHYl CORPORATION 

HEAlTH and ENVIRONMENT DEPARTMENT 

ETHYL TOWER, 451 FLORIDA 

BATON ROUGE, LOUISIANA 70801 

March 8, 1990 

CERTIFIED HAIL RETURN RECEIPT REQUESTED P 131 520 103 

Document Processing Center (TS-790) LJOffice of Toxic Substances A()OCll (l) Environmental Protection Agency ~ -C{Ou . 401 H Street S. W. 

Washington, DC 20460 

Attention: S(d) Reporting 

Dear Sir·: 

RE: [DPTS-82034; FRl-3666-9] Chemical Name CAS Registry # 

Hexabromocyclododecane 3194-55-6 

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::=: 

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In accordance with 40 CFR 716.35(a)(4), Ethyl Corp~ration 

hereby submits this list of studies previously sent to federal 

agencies without confidentiality claims. 

:0.'"1 

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. 

Chemical Name Hexabromocyclododecane CAS number 3194·55-6 

The following studies were sent on Hay 23, 1988 to: 

Mr. Robert Brink 

Executive Secretary TSCA Interagency Testing Committee (TS-792) 

U.S. Environmental Protection Agency 401 M Street, S. W. 

Washington D.C. 20460 

1. Mutagenicity Test of GlS-56-41A 

Lab GSRI 

Date of Study November 17, 1978 

2. Primary Dermal Irritation {Rabbit) 

Dermal corrosion {Rabbit) Ocular Irritation (Rabbit) Oral LDSO (Rabbit) 

Lab-Consumer Product Testing Company Inc. 

Date of Study October 17,~1978 

.· 
• 

3. 'Inhalation LCSO (Rat) 

Dermal LOSO (Rabbit) 

Lab Consumer Product Testing 

Date of Study November 7, 1978 

Submi~ting Company: 

Submitting Official: ··~\ 

Ethyl Corporation 451 Florida Blvd. 

Baton Rouge, La 70801 

Hs. Anne B. Lemmon 

Information Specialist Health & Environment Dept. 

451 Florida Blvd. 

Baton Rouge, La. 70801 

All tgchnjcal questions concerning this submission should be 

directed to Or. L. l. Wen, Regulatory Affairs at (504) 388-7650. 

ABL:pm 

Sincerely, 

ETHYL CORPORATION 

ll\w.! £> t~.r- Anne B. lemmon 

Information Specialist 
P. 0. Box 14799 

t (8 

ETHY1 COQPC)Qf['ION 

TECHNICAL CENTER 

TOXICOLOGY AND INDUSTRIAL HYGIENE 

July 1, 1985 

Genetic Toxicology 

Salmonella/Microsomal Assay 

Ames 087 - 1083 

HBCD Bottoms 

A. Mulholland 

& EPA-OTB 

I!IIIIIUDDRIII 

DiJDb3bbb4V 

"i'b.- "''C> <::DD t) 110 Lf 

Corporate Genetic Toxicologist 

Toxicology and Indus~rial 

Hygiene Department 

Baton Rouge, Louisiana 70898 

Telex 784583 ETC BTR 

Telephone (504) 389·7600 

8000 GSRI Awnue 

Baton Rouge, ·Louisiana 70820 
I. 

II. 

III. 

rv. 

v. 

VI. 

V!l. 

' 

TABLE OF CONTENT 

Summary .......................... . 

Study Description •.••.•••••. 

Protocol n " o o • • o o • " o " o o o 0 • • • o • o 0 0 o 0 0 0 0 0 0 • 0 0 o o o o • o 

Results and Discussion o o o "' • o o o o • • o • • • n " • • o o o o o o o 

Conclusj on •••• ;·,, ........................ . 

Data ............. " .................. " ................. .. Quality Assurance Statement 

Page 

1 

2 

3-4 

5 

5 

6 

7 
SUMMARY 

··: Test artIcle, HBCD Bottoms, was received as a brittle, black ,; 

sol..i d, 

"salmonella typhi.rnuri.um strains TA1535, TA1537, TA98 and TAioo 

were treated in the presence and absence of metaboll c activation 

{Aroclor 1254 i.nduced rat liver s-9 fraction) with HBCD Bottoms in 

acetone. Dose levels tested were 5.0, 1.0, 0.5, 0;1 and 0.05 

mg/plate. HBCD Bottoms was soluble at all dose levels tested. Each 

dose was treated in triplicate. An untreated control, solvent 

control and positive control were treated concurrently. 

HBCD Bottoms did not demonstrate toxicity in any strain at 5 

mg/plate. HBCD Bottoms caused a dose related increase in mutant 

colonies in strains TAlOO and TA1535 in the presence and absence of 

metabolic activation. 

-1-
STUUY DESCRIPTION 

Compound Name: HBCD Bottoms (PU-85121) 

G.T. li': 

Date Received: 

Received From: R .. Zussman 

Solvent: Acetone 

Doses Tested: 5.0, 1.0, 0.5, 0.1 and 0.05 mg/plate 

Assay Performed by: R. o. Johannessen 

Study Initiated: 4/15/85 

Study Completed: 5/3/85 

-2-
Sponsor·: 

Testing Facility: 

~~-~ 

,;I '' 

_;(i •• Test'• FacJ.tJ.ty 

:i 

s. oJ\? • Number 

Test Substance ::i 

Studv-Number: 

Purpose of. the Study: 

Study Director: 

Q.A.U. 

ReSJ?onsible 

Personnel: 

Rationale for 

Test sys tern: 

• .. ;· ~.:: -~: ·::,:.;~-· 

Date of Performance: 

Good Laboratory 

Practices Statement: 

PROTOCOL - ETTOX-027 

AMES ASSAY 

Salmonella typhimurium 

Ethyl Corporation 

8000 GSRI Avenue 

Baton Rouge, Lo~isiana 70808 

·. 

Genetic Toxicology Laboratory 

Ethyl Technical Center 

P.O. Box 14799 

Baton Rouge, Louisiana 70898 

ETTOX-0 27 

H t3 CD Bc-rto~JJ 

IP'J~ 0'67 

To evaluate the test substance over a wida 

range of concentrations for genetic activity 

using Salmonella typhimu'r'ium with and without 

the addition of a mammalian metabolic activation system. 

D. E. Johnson 

!3everly Pancamo 

Chemicals capable of inducing mutations have 

been shown to increase the reversion frequency 

at the histidine locus in selected tester 

strains of Salmonella tyrhimuri·um with and 

without the add~tion of a metabolic activation 

systems. , · (Ames, Bruce N., 'et_'al, ; ... Mutation 

Research 31: [1975] 347-~64,)·-,~-:-:-"·' · --- . __ 

The proposed date ot study initiation is one 

month from the receipt of the test. substance 

.and signed protocol. 

The study will be conducted in compliance with 

the Good Laboratorj.Practices Regulations as· 

stated in t.he Federal Register, Vol. 43, No. 

247 Friday, December 22, 1978. The study meets 

all EPA and OECD requirements.· 

-:,.· 

,, 
Pr:otocol 

Ames Assay 

Page 2 • 

; 

Tentative Date of 

submission of Final 

Report: 

Records Haintained: 

Raw Data: 

Archive Retention: 

Objective: 

Organism: 

Tester Strain: 

Source: 

Storage: 

Aseptic Technique: 

Working Cultures: 

Approximate date for submission of the final 

report to the sponsor is one month after study 

initiation. 

All correspondence pertinent to the ?tudy, 

protocol/ amendments to the protoco1, raw 

data, test substance weight or volu~e, 

dispensation reports, quality assurance 

reports and the final report·will be 

maintained in the Genetic Toxicology 

Labo_ratory - Ethyl Technical Center. 

Genetic Toxicology Laborat~ry Notebook 

All raw data. 

EXPERI~~AL PROCEDURE 

Plate Incorporation Ames Assay 

Salmonella typhimurium 

To evaluate the test substance over a wide range 

of ·concentrations for genetic activity using .:-

Salmonella 'typhimurium with and without the 

addition of a mammalian metabolic activation 

system. 

Salmone.lla typhirnurium 

TA1535, TA1537, TA98 and TAlOO 

Dr. Bruce N •. Ames, University of California, 

Biochemistry Dept., Berkeley, California 94720 

The tester strains as prepared in S.Q.P. 

ETTOX-021 are maintained at a minimum of -60"C, 

and serve ps master and stock culture. 

All aseptic"technique~, where. possible, are 

carried out in the ·Baker. NCB-4 Hood. 

Fresh cultures are prepared for each test 

according to s.o.P: ETTOX-020. 

Ames Assay: The plate incorporation Ames Assay is carried 

out accordin~. toAS.O.P. ETTOX-016, 017, 018, 

019 and 02~~0J1.¥:..etf' 

sponsor: _ £ +k-d Cofp., study Director: A ~a~...., ~' J It f ,ifs ~= -;«:7

& · · 

~4··· 
RESULTS AND DISCUSSION 

Color and appearance of t.he test article did not change from the 

time of receipt to the time of 

carbon, was present in all 

interferred with the automatic 

These levels were hand counted. 

- use. A black precipitate, probably 

dose levels. This precipitate 

colony counter at high does levels. 

HBCD Bottoms induced a dose related, reproducible increase in 

number of revertant colonies over the negative control ., in sister 

strains TA1535 and TAlOD. This frame shift mutation occurred both 

in the absence and presence of metabolic activation. The S-9 

activating system neither increased nor decreased the mutagenic 

potential of HBCD Bottoms. 

Data are given on next page. 

CONCLUSION 

HBCD Bottoms was genetically active in the Salmonella/ Microsome 

Assay conducting according to Protocol - Ettox 027. 

-5-
HBCD Bottoms 

DATA 

' Solvent Positive 5.0 1.0 0.5 0.1 

strain Activati.on Control Control mg/plate mg/plate mg/plate mg/p1ate m

TA1535 - 2 882* 544* 49* 29* 8* 

+ 4 28* 5 7 4 11 

TA1537 - 8 202* 7 8 7 7 

+ 10 993* 8 9 8 8 

'TA98 - '16 690* 30 ' 24 21 16 

+ 28 2664 25 22 18 13 

" .. 

TA100 - 84 2173* 496* 99 77 96 

+ 80' 2506* 851* 112 123 ' 72 

.. ·- ·- ·- ----- 

* 3 times solvent control .. ·.-, 

-6-

""=""• 
' ' ,._ 

\ E T B Y L C 0 R P 0 R A T I 0 N 

' QUALITY ASSURANCE UNIT STATEMENT 

This study was performed in accordance with the Good Laboratory 

practices Regulations for nonclinical laboratory studies developed 

by the u. s. Food and Drug Administration and Environmental 

Protection Agency. 

study No. ~mes 087 - 1083 

The followi.ng inspections 

Interval 

Reporting Phase 

'· '· "·""r 

( 

were performed: ; 

Date 

5/22/85 

=~--~, .. , ______ _ 

Results of the above inspections were• submitted to the study 

Director and Management during the course of the study. 

'(Date) 

-7-
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Ill 

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