llllllllllllllllllllllllllllllllllllllllllllllllllllllllllll • 

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 

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/'i~"":\ U.S. DEPARTMENT OF COMMERCE 

• ~· • Technology Administration 

\ 

• · / National Technical Information Service 

...,. "' Springfield, VA 22161 
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. :··~~ 

.-::ert,:i:fied Mail ~'r 'i~ooco-a8r 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 

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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 

.... 

0 "' 

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 Biddle Avenue, Wyandotte. Michigan 48192 (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 , .. ,, 
. - - --, . --·-<t!.V 'I 

( HRC) ~X OONrAINS NO CBI • 

HUNTINGDON RESEARCH GENTRE 13

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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, 

Postfach 91 02 11l, 

5 Koln 91, 

WEST GERMANY. 

19 September, 1978. 

l'. 

,. .Authors: 

David J.N, Hos_Sl;ck, 

Margaret Richold, 

Eryl Jones, 

Robert P. 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: 

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.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; 10 pg/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 colcny counting difficult end possibly· 

inaccurate (indicated by 'P' in Table 1). · 

•i 

No significant increase in the number of revertant colonies was observed with 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 of Compound Nc, 49 wos 

obtained in this bacterial test system at the dose levels used. 

-, 

.. 1 
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.. 

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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) 

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