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# • OTS0522948 One Source. One Search. One Solution. 

# AMES METABOLIC ACTIVATION TEST TO ASSESS THE POTENTIAL MUTAGENIC EFFECT OF UNO NO. 49 WITH COVER LETTER DATED 031290

19 SEP 1978

U.S. Department of Commerce National Technical Information Service

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### CODING FORM FOR SRC INDEXING REVISED 10/15/86

. OTS0522948

AI>IES METABOLIC ACTIVATION TEST TO ASSESS THE POTENTIAL

**~IUTRGENJC** EFFECT OF UND NO. 49 WITH COVER LETTER DATED 03129(1

HEXABROMOCYCLODODECANE (3194-55-Gl

### r· . . . . 

## /' OONTAJNs NO Cs; 

### BASF Corporation 

# BASF.

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# ~'r **'i~ooco-a8r** .-::ert,:i:fied Mail Ret,f.rn Receipt Requested March 12, 1990 Attention: 8(dl Health 

### & safety Reporting Rule

**Notif~cation** 

## ·u. s. Environmental Protection Agency

Docwnent Processing center (TS-790) Office of Toxic Substances 401 M Street, sw washington, DC 20460 Ladies and Gentlemen: subject: Health & Safety Study Reporting 54 Federal Regist.er 51114, December 12, 1989 25th ITC Report " lO Q 

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### In response to the TSCA reporting rule referenced above, BASF corporation is submitting the attached studies on: CAS Reg. No. 1163-19·5 3194-55-6 32534-81-9 32536-52-0 DECKBROMOD!PEENYLETEER Decabromodiphenyl Ether Hexabromocyclododecane Pentabromodiphenyl Ether octabromodiphenyl Ether CAS REG. NO. 1163-19-5 0 

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1. Bericht uber Versuche zur Errnittlung der mittleren todlichen Dosen fun£ verschiedener Verhindungen, 10.03.1976 2. Ames Metabolic Activation Test to Assess the Potential Mutagenic Effect of Bromkal 82-0 DE, 08.02.1978 3. Ames Metabolic Activation Test. to Assess the Potential Mutagenic Effect of Muster 83, 17.10.1984 4. .Ames Metabolic Activation Test to Assess the Potential Mutagenic Effect of Muster 88, 16.10.1984 5. Final Report. 14-Day Repeated Dose Feeding Study - Mice, 3.3.11.1978 6. Final Report. 14-Day ,Repeated Dose Feeding Study - Rats, 14.11.1978 7 • 90-Day Subchronic Feeding Study oin Rats on Decabromodipheriyl· OKide, 27.07.1979

**~·**
t609 BiddleAvenue,Wyandotte. Michigan48192

**(31~) 246-61~**  ': ''' .. ' 

### )\•·

# •Page 2 u. s. Environmental Protection Agency DECABROMODIPHENYLETHER CAS REG. NO. 1163-19-5 (Cont.)

8.**90~Day** Subchronic Feeding study in Rats on Decabromodiphenyl Oxide, 27.07.1979 9. Results of 30-Day Rat Dietary Feeding ,.studies on Octabromobiphenyl SA-1902 and Decabi:omodiphenyl oxide SA-1892.1, 28.01.1971 10. Ergebnisbericht uber Untersuchungen zur Bild\mg von Poly- bromdibenzofuranen und -dioxinen wahrend der Extrusion von Polybutandiol-terephthalat (PETP); Flamrnschutzmittel: Decabromodiphenylether 11. Untersuchung zu1: Bildung von l?olybrom-dibenzofuranen und dioxinen bei der Extrusion von Poly-Butanediol-terephthalat (l?BTl?); Flammschutzmittel: Decabrom-diphenylether; Teil 2; Produktionsanlage HEXABROMOCYCLODODECANE CAS REG. NO. 3194-55-6

' l. Prufungsbericht uber die toxikologischen Untersuchungen mit Hexabi:omocyclododecan der Firma Chemische Fabrik Kalk GmbH, Koln-Kalk an Laboratoriumstieren, 04.10.1971 2. Bericht uber die l?I:ufung der akutan Toxizitat an der Goldorfe (Leuciscus idus L., Goldvariante), 18.03.1988 3. Ames Test for Hexabromid S, 24.04.1978 4. Hexabromocyclododecane: 28-day feeding t1:ials with rats (with Germany summary- 17.11.1969) 5. Hexabromocyclododecant 90-day feeding trials with 1:ats (with Gel:many sUlt\lnary 04.02.1970) 6. Report on the study of the irritation of Hexabromocyclodo- decane to the dorsal skin of rabbits after 20-hour exposure, 04.10.1962 7. Report on the study of the primary**i:::::it~** :ion of Hexabl:omo-· cyclododecane to the eye of rabbits,**().,..;~:0.1962** 8. Report on the study of the acute oral toxicity of Hexabromocyclododecane in the mouse, 04.10.1962 9. Notiz: ALD 50, Ratte, oral, 28.11.1962 10. Ames metabolic activation test to assess the potential mutagenic effect of compound No. 49, 19.09.1978 ·.,Page 3 U. s. Environmental Protection Agency HEXABROMOCYCLODODECANE CAS REG. NO. 3i94-55-6 (Cont.) 11. Migration von HBCD aus gesqhaumtem Polystyro1, 27.06.83 12. Migration von Flammschutzmitteln aus

**ge~chaumtem** Polystyrol 08.08.85, 19.12.85, 28.08.86 . . 13. Al?ME: Expandable Polystyrene Information Dossier, p 18 with» Data to Aquatic toxicity and Bioaccumulation (log Pow a.o.), March 1988 14. Algal Growth Inhibition Test, 1990/01/31 15. Determination of the acute toxicity of Hexabromid s to the waterflea Daphnia magna Straus, 1990/01/.30 16. Oxygen Consumption Test (using Pseudomonas putida by the test method of Robra), 1989/04/19 17. Biologische Abbau Tests, 1980/05/06, 1981/10/16 PENTABROMODIPHENYLETHER CAS REG. NO. 32534-81-9

1. Prufung der akutan Toxizitat au der Goldorfe, 13.02.1984 2. Toxicologische Prufung von Penta-brom-diphenylaether 3. Prufung von Bromkal 70-5 DE im Augenreiztest am Kaninchen, January 1981 4. Prufung von Bromkal 70-5 DE im Hautreiztest•am Kaninchen, January 1981 5. Ames metabolic activation test to assess the potential mutagenic effect of Bromkal 70-5 DE, 08.02.1978 OCTABROMODIPHENYLETHER CAS REG. NO. 32536-52-0

1. Bericht uber Versuche zur Ermittlung der Vertraglicrlkeit von Bromkal 82-0DE-Ruckstand, Bromkal 79-8DE-niedrigschmelzend und Bromkal 79-8DE-Ruckstand, 04.09.1984 2. Ames metabolic activation test to assess the potential mutagenic effect of Muster 84, 12.10.1984 3. Ames metabolic activation test to assess the potentia,l mutagenic effect of Muster 82, 30.10.1984"Page 4 

## u. §· Environmental Protection Agency OCTABROMODIPHENYLETHER CAS REG. NO. 32536-52-0

4. Ames l.)etabolic activation test to assess the potential mutagenic effect of Muster 13, 15.05.1978 

## 5. Prufung von Bromka1 79-8 DE im Augenreiztest am Kaninchen_ .. June 1980 •'· 6. Prufung von Bromkal 79-8 DE im Hautreiztest am Kaninchen, J1me 1980



### ,, r-:!· 7. Bericht uber Versuche zur Ermittltmg der mittleren todlichen Dosen funf verschiedener Verbindungen, 10.03;1976 8. Bericht uber Ver.suche zur Ermittlung der mittleren todlichen Dosis von Brornkal 79-8 DE, 21.05.1976 Submitting Site: submitting Official: BASF Corporation 8 Campus Drive Parsippany, 

### NJ 07054 Roberta A. Burley Sr. Product Regulations Specialist BASF Corporation 1609 Biddle Avenue Wyand.otte, MI 48192-3799 Telephone: (313) 246-6214 Please contact me at 313-246-6214 if you have any questions.

mk Enc. Very truly yours, BASF CORPORATION 

# 4-bJ.A 

# jJJ_ctr--- Roberta A. Hurley Sr. Product Regulatio s Specialist
,

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HRC)



# ~XOONrAINS NO CBI • 

# HUNTINGDON RESEARCH 

# GENTRE 13" 1



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# ·
**~~~~~~~m~I~II~III~D** [JIJ[)b88458$ '· AMES METABOLIC ACTIVATION TEST TO ASSESS THE POTENTIAL MUTAGENIC EFFECT OF 

## '"coMPbUND No. 49'

Addressee: Dr. Kerscher, Chemische Fabrik Kalk GmbH, Postfach91 02 11l, 5 Koln 91, WESTGERMANY. 19September, 1978. l'. ,. .Authors: DavidJ.N,Hos_Sl;ck, Margaret Richold, ErylJones, RobertP.Bellamy; 

### '.!lupe-"Vision according to the procedures hereiii



### desctib;d~

## -;;;;d-i:ha.T'tht; :report provides a correct and fail:hful record of the results ·obtained.

David J. N. Hossack, M.Sc., M.I.Biol., Read of Department of Cell Riology ancl Microbiology
Margaret Richold, R.Sc., M.PhU., Read, Mutagenesis Section,

**.,.-~.,** Department of Cell Biology ancl Microbiology ( ...



### ~.,.,;~~---:::::'" .Eryl Joues, A.I .•M.L.S., M.I.Bicl•• B.Sc., Scientific Officer, Department of Cell Biology and !'.icrobialogy

Robert P. l!ell=y, B.Sc., Scientific Officer, Department of Cel.l Riology and Microbiology 1:; ..

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.



### ·:·~·\.,_._,...____ ,

**.-:-~:1:** I( \It . ' .CLIENT : Chemisehe Fabrik Kalk GmbH. COMPOUND , Organic bromide

.. .--, ,.., - -· - Code number : 49 Structural Formula :

**~** METHOD, 

# . The method used is described in HRC Protocol MCB/101 Solvent : Dimethylsulphoxide Dose levels : Bacteriostatic test: 10,000; 1,000; 100; 10pg/well Mutation test: 10,000; 1,000; 100; 10 fig/plate RESULTS : The results of the Mutation Test are shown in Table 1 overleaf. 

### CONCLUSION AND COMMENTS : At the highest ccn<::entrotion Compound No. 49 precipitated out of$Oiuticn when mixed with the soft agar, This precipitate made colcnycounting difficult endpossibly· inaccurate (indicated by 'P' in Table 1). · •i

Nosignificant increase in the number ofrevertant colonies was observedwith any of the five tester trains after treatment with Compound No. 49, either In the presence or absence of liver microsomal fraction. It is ccnc:lucled that na eviclenc:e ofmutogenic: potential ofCompound Nc, 49wos obtained in this bacterial test system at the dose levels used.

-,



### .. 1N .. ;:. Solvent co• c. **'<~I** ... Solvent control Positive control• • •• .t"> HRC- AMES TEST •• TABlE 1 SUMMARY OF MUTATION DATA*

Test material: Compound No. 49 **~** MEAN NUMBER REVERTANT COLONIES PER PLATE

Test compound Metabolic TA 1535 TA 1537 TA 1538 TA98

pg/pluto nr,tivation of,

- 22 71

10,000 - 15P 7lP

1,00() - 19 69

100 - 23 65

10. - 21 70

- + 9 50

+ 253 148

10,000 + liP 60P

1,000 + 14 68

100 + 10 69

10 + 14 52

" if (·'

• Full mutation dala available on request. .. TA 1535 P-naphthvlamlne 10 pg/plata

:::-

TA 1538 2-acatylaminofluorene 20 "gfplata

TA 1537 Neutral red 10 pg{plate

TA 90) 2-nmlnonllthracane 20 pg{plato

TA 100)

r:. **~:·** TA 10[) 34 56 55 53 45 36 146 44 42 42 44

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