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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

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# - U.S. Departmentof Commerce 

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U..S. DEPARTMENTOF COMMERCE TechnologyAdministration NationalTechnical Information Service Springfield, VA 22161

### 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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### 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 MStreet, 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 SpecialistP. 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 

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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,·Louisiana70820I. II. III.



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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 Conclusjon •••• ;·,, ........................ . Data 

# ............. "

## .................. "

# ................... Quality Assurance Statement Page 1 2 3-4 5 5 6 7SUMMARY
··: Test artIcle, HBCD Bottoms, was received as a brittle, black ,; sol..id, "salmonella typhi.rnuri.um strains TA1535, TA1537, TA98 and TAioo were treated in the presence and absence of metabollc 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 systern:

•

### .. ;·**~.:: -~:** **·::,:.;~-·** 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 

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# 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: _

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**~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 0.05 -

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

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

+ 4 28* 5 7 4 11 5

TA1537 - 8 202* 7 8 7 7 9

+ 10 993* 8 9 8 8 12

'TA98 - '16 690* 30 ' 24 21 16 22

+ 28 2664 25 22 18 13 22

"

..

TA100 - 84 2173* 496* 99 77 96 76

+ 80' 2506* 851* 112 123 ' 72 76

.. ·- ·- ·- ----- ·-

* 3 times solvent control ..

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### 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

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Results of the above inspections were• submitted to the study Director and Management during the course of the study.

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