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THIS DOCUMENT HAS BEEN PREPARED ACCORDING TO THE

PROVISIONS OF ARTICLE 136(3) TRANSITIONAL MEASURES

REGARDING EXISTING SUBSTANCES OF REACH

(REGULATION (EC) 1907!006)" IT IS NOT A PROPOSAL FOR A

RESTRICTION ALTHOUGH THE FORMAT IS THE SAME


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ANNEX XV REPORT

(TRANSITIONALDOSSIER)

SUBMITTED B#$ F%&'

DATE$ N*+,-% !00.

SUBSTANCE NAME C/


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A. SUMMARY

C/*%**%, 4 & 5%*% 48-4&' *' / !' 5%*% 4 ' / %&,:*%; * C*8'

R 45& ' /

5/&%,&8& '84% (*% =&,5 ' / =%&*' * 5'' &' */%

&'-*4)> &4 & /,& '%,& ' / 5%*8*' * 4> 544 &' */%

48-4&'4 &' &4*> -8 ' & 44 ='> &4 & %4;4 /&+ -' ' *% / **:' - *'%* - '&*'& %84 *% -

5%, * '48% /& '* %4; *% / '+%*',' 4 =5"

B&4 *' / /8,&' /&/ &4444,'> %4;4 /&+ -' ' *% / **:'%%&*'> RDT ('/&&*' &' *,-')> &%'* %%&*'> RDT ('/&&*' &' *,-')>

&%'* *'84*' () &554 * /8,&'

=5*4 +& / '+%*',' & *& 4& *% RDT (*&) +& &%> RDT &'

&%'*


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B. INFORMATIONONHAZARDANDRISK

B.1 Identity of the substance(s) and physical and chemical properties

B.1.1 Name and other identifiers of the substance(s)

This section was built with parts 1.1 of EU-RAR(2007). More etails are a!ailable inthe ocu"ent #oine in anne$ %& ossier.

C/,& N&,$ 1>1>12T%/*%*,/&'

EC (EINECS) N8,-%$ !0026632.

CAS N8,-%$ 6726623

IUPAC N&,$ C/*%**%,

O/% '&,4$

%/*%*,/&'>

T%/*%**%,

*%, %/*%>

F*%,/*%

,/&' %/*%>

/ /


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B.1.2 Composition of the substance(s)

This section was built with parts 1.1 an 1.2 of EU-RAR(2007). More etails are

a!ailable in the ocu"ent #oine in anne$ %& ossier"

T&- B"1"!21$ C/*%**%, /,& 4%5*'

Main substance

C/,& N&,$ 1>1>12T%/*%*,/&'EINECS N8,-%$ !0026632.

CAS N8,-%$ 6726623

IUPAC N&,$ C/*%**%,

M*8&% F*%,8&$ CHC3

S%88%& F*%,8&$

M*8&%


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T&- B"1"!2!$ C/*%**%,4 ,58%4 /,& 4%5*'

Impurity 1

C/,& N&,$ /*%*-%*,*,/&'

EINECS N8,-%$ !002.!623

CAS N8,-%$ 7?2972

IUPAC N&,$ -%*,*/*%*,/&'

M*8&% F*%,8&$ CH!B%C

S%88%& F*%,8&$

M*8&%


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S%88%& F*%,8&$

M*8&%


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IUPAC N&,$ 1>12D/*%*/'

M*8&% F*%,8&$ C!H!C!

S%88%& F*%,8&$

M*8&%


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B.1.3 Physico-chemical properties

This section was built with part 1.' of EU-RAR. More etails are a!ailable in the

ocu"ent #oine in anne$ %& ossier.

C/*%**%, 4 & +*&> /&+> **8%44 @8" I 4 '*'2&,,&- &' 5*44444 &

/&%&%4 4: **8%"

T&- B"1"321$ S8,,&% * 5/4*2/,& 5%*5%4 * / 48-4&'


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B.2.1 "anufacture and import of the substance

T/ 5%*8*' * /*%**%, 4 *& & '' 44 ' / E8%*5&' U'*' (*' *

/ ' 44 4*55 ,&'8&8%'< /*%**%, ' !00?)" T/ *& EU 5%*8*'

+*8, :&4 30! .00 *''4 ' !00!" /' &;'< '* &*8' ,5*% &' =5*%

+*8,4> /4 &''8& *''& '*'2&& /*%'&*' * ,/&'" T/4 *' 4& "


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!013 (& / &+%& / % * HCFC4 *'48,5*' /&4 -' %&'4& '* &

4 !36>.00 ' 1991> !?>700 ' 199!> !?0>600 ' 1993

&' !39>?00 ' 199?"

T*& HCFC2!! E8%*5&' 5%*8*' 4 4,& * /&+ -' &55%*=,&

10 000 199 / 3 000 - (


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#$2$2$2$ Solvent or(and other applications

I' / 5/&%,&8& '84%> /*%**%, 4 84 &4 4*+' *% =&,5 ' /

=%&*' * 5'' &' */% &'-*4" E4:/%> /*%**%, 4 4 84 &4

4*+' *% .00> / 84 &4 '%,& ' HCFC2!! 5%*8*'

!?>!00> / 84 &4 4*+' )!""> / */% 844 /' HCFC2!! 5%*8*' &' &44*+' )!1"" tonnes"

B.2.3 #ses ad$ised a!ainst by the re!istrants

'*'

B.3 Classification and labelling


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* /%'

S 3,(3&% 48&-5%*+ */'< &'


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0"0? ,*'/21> :// *%%45*'4 * & hal*'li*e o* 1- months at 2- .%" T/ 48

:&4 *'8 *% 1! ,*'/4 :/ & CHC3*''%&*' * 1 55, ' 19.9 ,&48% ,4 & %' 5H

+&84" T/ /&2 & pH /as 1)-" years at 2- .%> & 5H 9> !? &%4 &' 0"!?

&%4 & 5H 11" N* & &&44 :&4 *-4%+"

%onclusion0 hydrolysis is an unimportant *ate process at a neutral pH value$

Photolysis in /ater

H8-%/ &' S8/> 19.0 &' D' 197 '* *-4%+ &'5/** 19.7 4 5%*-&- *' ,5*%&' ' / +% 855% 48%& &% &' 5'4 *'

/ 44*+ *%


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*5% &' D&'> 1990 &8& &*%'< * A;'4*'> 19. & %& *'4&' *

H 1

.

1"

'13

cm

3

(molecules$s$ I' & %+: * / &,*45/% %&*'4 */*%**%, A;'4*'> 19. %*,,' & %& *'4&' *% %&*' * /%*=

%&&4 :/ /*%**%, * H

1$"3 .1"'13cm3(molecules$s"

U4'< / 45 &4 %*,,' - A;'4*'> 19.> &' 84'< & ,&' OH

*''%&*' * 00>000 ,*84,3> & 548* %4 *%% %& *'4&' *%

1990 &8& &*%'< * A;'4*'> 19. & %& *'4&' *

73

2$,.

1"'1,cm3(molecules$s$ U4'< & ,&' NO32%&& *''%&*' *

1 .10.,*84,3> & 548* %4 *%% %& *'4&' *%


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*8% /%*8 &,,*'&) &' / *%%45*''< -&%& &% 5%4'"

In conclusion! the results by 9aba et al.! 1:)1 could not be con*irmed under

more realistic conditions$ 9here*ore! in this assessment! a *irst order rate

constant *or bioderadation in sur*ace /ater o* " d'1/ill be used$

in soil,

7o results *rom standardised bioderadation systems *or soil and sediment are

available$

I' & 48 5%*%, *' & 4&' 4* (S%&' &' S/55%> 19.6)> :&4 *8' /&&,&*' * &' &%2'&8%&


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&55&%4 * /&+ -' & 19.3 *8' /& ' 4 88%4 8'% ,/&'* && *% 5%*5*'&) 4* &4 * ,&'&' &*''%&*' * !000 , 1!30 &' 1960 , *%%45*''< * *''%&*'4 *J0"!?> J0"9.> J1"7 ,


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4 &'&%*- &' 48


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B." #uman health ha$ard assessment

*or "ore etails+ refer to section .1.2 of the RAR (hu"an health).

B.,.1 o&icoinetics

This is a su""ar of the "ore etaile chapter .1.2.1 of the RAR.

C/*%**%, 4 : &-4*%-> ,&-* &' ,'& - ,&,,&4 &% *%&>'/&&*' *% %,& =5*48%" C/*%**%, 4 /' : 4%-8 ' / '%

*% &' *%&2

=5*48% 48 *8' ,*4 * / /*%**%, *4 -'< ,'& :/' . /*8%4

5*4=5*48% (F% &" 197! ' ATSDR 1997)"

C/*%**%, 4 ,&' ,&-*4 ' +% &' -*/ *=&+ &' %8+ 5&/:&4

* /*%**%, /&+ -' '> &/*8


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C/*%**%, &8 *= && &% &+&&- *% '/&&*' &' *%& %*8 ' %&4 &'

, &' *% / %,& %*8 ' %&--4" S*, 484 *' '& 84 &' *'&'& /8,&' =5*48% /&+ &4* -' %5*%"

A8 *= +&%4 5''< 85*' / 4%&'> 4= &' +/" I' , / *%& LD0+&84 %&' /

%&' 1996-)" T/ 5/& 4 * / 5%*=,& 8-84

* / ;' *%= :% / 5%,&% &% 199?) &' / *%& LOAEL 4

J107 , 197. ' HO> 199?)"%onsidered as ey studies

*or ris characterisation


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R&--

D%,&

N*%5*%

L@8/*%**%,

!?/> *84+10 &55&*'4

*% &%4

! &55&*'4 *%

-4

&%$ /5%,& &'=*&*' &% 1 * ?

&55&*'4-$ 4 *44'* 45

66 4+% %%&*'>

:/ ,%&44 &';%&4

?6 %&'48' *'4 '/ *%'&

D85%& &"> 1976

R&--

O8&%

3 U'8

/*%**%,> *44'* 45

1 %'4 &%304

S !00!


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M*84> BDF1

I'/&&*'

104=*4 +&5*8%> 6/>

:;> 13

:;41!> !> 0> 100>!00 55,

! 55, (1! ,

*4'*5/ /&' !00!

M*84>

B6C3F1I'/&&*'

F,& 0"3> !> 10> 30> &'

90 55,6 /> ? &4

NOAEC 90 55, (??1

,


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&55 * &'

5*%*' &' %&4 45*'&'*84 ,*+,' :% *-4%+ *% 1 :;

**:'< '%&%,& &,'4%&*'" I' / +&8&*' & ?. &' 7! /*8%4 &% /

4&% * /&' %/,& (4*% 1 *% !> 4 &'HCA :&4 44*+ ' /*%**%, *% ' &*'*+ * 4*+' (AOO &*' $

*+ * ? $ 1) * %&/ & *''%&*' * 10" U4'< ? !"96 MB@,L) &' / &8%8&%

/ / /


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, %5*% *%& LOAEL4 :% 0 , /5%5&4& &' *, !00?)" T/ %5*% '/&&*' NOAEC *% &

90 &4 48-2/%*' =5*48% :&4 ! , 8-8 '%*44 &' '&% &'

'%&4 &5& 8-8 /5%5&4& &' '8&% '&% , && *' %5& *4

*= 48


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:> '*'24&'&% 484 '& / 5*44- * & :&; 5*4+ %45*'4 ' %&4"

O+%&> /*:+%> / :


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4&-4/ & &84& %&*'4/5 -:' =5*48% * /*%**%, ' %';'< :&% &'

'%&4 %4; * &'%"

T/ NOAEC +& '/&&*' *% / ;' &'*,&&%'*,& :&4 ' &

55, ' ,> *% '&4& 4*'4 & LOAEC * 55, :&4 %,' (#&,&,** &">

!00!)" O%& %&,' :/ /*%**%, :&4 &44*& :/ '%&4 '' *

,*%& * 4+% ;' 4*'4 ' CBA &' CF1 ," NOAEL 17 , &',& ''


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7 /%&> &% 4=

%&* &' %&4

& :19..

4&% %&4

3nhalation

0> 30> 100> 30055,

7 /%&> 3> 10> 30 55,

7 /%&>


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9hompso

n et al.!

1:4

R&--4

G&+& !0> 3> 0

,

1979

ICR ,

0> 31"1 , ?1"!,


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B.' n!ironmental ha$ard assessment

B.*.1 %8uatic compartment (includin! sediment)

T/ **:'< +& 4 %484 /&+ -' 4 *% / %,'&*' * & PNEC

*% %4/:&%"

F4/$ NOEC269 ,*'/4 1"?63 , &' &4444,' &*% * 10 4/*8 - &55 * / *:4

NOEC> :// 4 / *' %*, / 4 *' / ,


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B.*.3 %tmospheric compartment

T/ *:4 4 *''%&*' & :// 4 :% *-4%+ *% +4- 4,5*,4 &'

5/**4'/44 :&4 100 / 5*'& *'%-8*' * /*%**%, * ,& /&'


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B.+ ,posure assessment

B.+.1 -eneral discussion on releases and e,posure

This section is a su""ar of the "ore etaile chapter .1.1 of the hu"an health RAR

(;; RAR upate in 4ctober 200).

H8,&'4 ,& - =5*4 * /*%**%, & :*%;5& &' '% +& /

'+%*','"

C/*%**%, 4 &4* & /,& -25%*8 &44*& :/ 4'*' * 4:,,'

'

&-*%&*%

N* *'%' 0

3"1 S:,,'< L@8 A+ ' N* *'%' 0 M&48%,'


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Table B%&-, S!stemic doses per da! #ia inhalation. #ia s*in. #ia ingestion and total s!stemic dose foroccupational ris* assessment

S'&%* S4, *4 5%

& +& '/&&*'

(,


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P%*8*' $

S A $ ,$3


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L& %*54 1"71023,


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S/immin pool :&% /&4 -' %5*% &4 & 4*8% * /*%**%," I' F%&' /

4:,,'< 5**4 :% ,&' 4' - 84'< /*%'& *,5*8'4 &4

/*% *% 4*8, *% &8, /5*/*%" A*%'< * / ,*% %' &+&&-&& & / , * / %4; &4444,'> '* &%'&+ * /4 /*%'& %&,'4

&% =5 ' / '= &%4 *% 58- 4:,,'< 5**4" L+4 * /*%**%, '

:&% &' %&' " C/%*,&* 710(1)$1.1290)"

I' F%&'> 8'4 &% 848& '* * *:&%4 ,8'5& :&4 :&% -8 %&/%

*:&%4 / %&':&% ':*%;" H*:+%> 45'4&*'4 &' -


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%&'4*%,&*' 4 '* =5 * - & 4 !00!"

T%%4%& N&8%& S*8%4 * T%/*%*,/&'$ A' O+%+:" B* V*"

60> N!> B*


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B.., 0ummary of en$ironmental e&posure assessment

Manu*acturin

This section was built with part '.1.1 of the RR on the basis of the RAR infor"ation.

More etails can be foun in section '.1 of the RAR(en!).

A*%'< * US2EPA (19.?)> *444 *' % -:' / :* 5%*444> /%*%

'* 4'*' :&4 ,&" T/% &% ' ,&Q*% /*%**%, 5%*8*' 44 ' EU :/

&' *+%& 5%*8*' * 30!>.00 *''4 ' !00!" A,*'< /,> ? 44 (A> C> E> &' )

/&+ & PECPNEC %&* &-*+ 1" F*% 4 E> '* %4; 4 =5 %*, /*%**%,

5%*8*' &*'> -8 %&/% %*, 4 &44*&*' :/ HCFC!! &' 4544

5%*8*'4" T/84> %&44 * :&4:&% 2 &8& 84'< & %,*+& +&8 * ."6

2 &% !" 600 *''4 84 &4 '%,&" E,44*'4 * /*%**%, * :&% *,5&%,'4

:% &+&&- *% . 44 *8 * 10" F*8% * /, * PECPNEC %&*4 &-*+ 1"

T/ /


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B.1/ 0is characterisation

B.15.1 =uman health

H8,&'4 ,& - =5*4 * /*%**%, & :*%;5& %*, / '84%& 5%*8*' *

/*%**%, *% '% ' 4:,,'< 5**4 &' +& / '+%*','" T/ 84 *

/*%**%, 4 , * 5%*44*'& &' '84%& &55&*'4 /%*8 +& -** %8&*' &'> 8 * 4 5*4*8-> 5%%'& ' &

4484 &' ' / -%&'" N&% & 4484 * / -* &% &5&- * ,&-*' -8 / %& * ,&-*4, 4 &' '&4&

,8*4&"

C/*%**%, &' %*44 / 5&'&> %&'45&'& %&'4% /&4 -' %5*% ' ,

(D&'44*' &"> 19.6 ' HO> 199?) &' ' / & -** ' %&4 (/ &'

&%5'4;> 19. ' HO> 199?) &' 4 =5 * &55&% ' /8,&' **4%8, &'

4 =% ' ,&8% -%&4 ,; (L/'% &"> 19.. F4/% &"> 1997 ' H&/

C*8' * / N/%&'4> !000 D&+4*' et al.> 19.! ' US EPA> !00?)"


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C/*%**%, LC0 +&84 * 6!00 , 1996-)" T/ 5/& 4 *

/ 5%*=,& 8-84 * / ;' *%= :% / 5%,&% &% 19.3 ' HO> 199?)> *%& & LOAEL J107 , 199?)" H*:+%> &% &' 855% &%:&4" R&-- %,&484 4/*: 4 *'&

:/ @8 /*%**%, &84 ,5*%&% *%'& 5/8, 'Q8%" M&' %5&

*4 484 /&+ -' %5*% *% %%&*'> /*%**%, '8 4*' &'

5%*%&*' ' / *&*% 5/8, -8 &4* -*'


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%&4" L4*'4 &' 5%*%&*' ' / *&*% 5/8, &' /&' !00!)"

T:* 484 4/*: '&4& 4*' ' %&4 *% , 8 * /*%**%, '/&&*'> *%


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B '/&&*'> / 4 * /*%**%, *' / +&%*84 &',&4 4 '8 4

*' 5% %4*%5*' %&> % 4 &' + 844" T/4 4 /&+ -'

*-4%+ :/ *''%&*'4 &84'< & %&4 * ,&%'& : &4 : &4 4;& &'

1991) &' &'

*%& LOAEL * !0 ,


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S8,,&% * / %4; /&%&%4&*' *% :*%;%4

+cute to$icit! 2ocal to$icit! after single orrepeated e$posure

Sensiti

sation

epeated dose to$icit!S!stemic

4uta

genicit!

Carcino

genicit!

To$icit! forreproduction.

3!'$l$tio!


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#$1"$1$2$ Ris *or the consumers

A4 / 84 * /*%**%, 4 , * 5%*44*'& &' '84%& &55&*'4 /%*8 *,5+ 4:,,%4 &' *% *'48,%4 &4 / 4:,,%4 &' &8

4:,,%4 4/*8 - &%44 ' / S*8, H5*/*% RAR (%484 * RC *% 4'&%* 3 &% 5%4' ' A''= 1 * / RAR *%

'*%,&*')"

B.15.2 is for the en$ironment

T/4 4*' :&4 -8 :/ 5&% 3"3"! * / RRS"

I' / **:'< 4*'4> *' =5*48% &' %4; &4444,'4 /& /&+ %48 ' / '&*' * %4; &% *' /&+ -' 4844 ' *%%

* /


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S,'$

F*% & 5%*8*' 44> PECPNEC2%&*4 &% -*: 1" I &' - *'8 /& /% 4 '* %4; * 4,' *% 10 ;


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U''' %&44 S:& & :*%42&4 4'&%* /&4 -' &'5& &'< * & PECPNEC2%&* &-*+ 1" H*:+%> 4/*8

- 45 /& '* 4 &' 544 &% &8& 5%*8 *' /4 4> /4 %&* :*8 & -*: 1 *% 4 E"

S5 '*%,&*' *' 4:& / *& 4%' E8%*5&' *'48,5*' * 8*%*&%-*'4 :&4

4,& 19.>000 *''4 ' !00" T/4 ,&'4 /& / *,5 4*5 * HCFC2!! *8 &; ,*% , &' ' *+% *'4%&'4 * -

&/+"

U4 * /*%**%, &4 4*+'$

T/ PEC:&%+&8 *% /4 4'&%* 4 -&4 *' 8' ,*'*%'< ' F%&'" I' /4 ,*'*%'< 48> /*%**%, *''%&*'4 , :// 4 -&4 *' 8' ,*'*%'< ' F%&'"


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C*'4%&*' * / %4; *:&%4 STP$

I *8 - *'4% /& ,%**% / 84 &4 4*+'> %&4 / PECPNEC %&* * 7"!6 ?960"01> & & conclusion iiB:&4 %+ *% /4

*,5&%,' -&4 *' & @8&&+ &4444,'"

Non compartment specific effect through the food chain:

S' -*&8,8&*' 4 *:> &


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T&- B"1121$ I'+'*% * / %&44 &' PECPNEC %&*4 *% /*%**%, 8%'< / +&%*84 4&


53/62

releases)

III& Dnintended

*ormation as by'

product

L*444 &4 & - 5%*8

8%'< VCPVC &' */%

/*%'& 5%*84

,&'8&8%' R?> R?6> &' R?7 8'% D%+ 67?.EEC) ' A''= I * D%+

9!.EEC> / '*'2=/&84+ 4 * & 199? O"" (L !16) 1!> !0 A8< 199?(C/*%**%, 4 '8 ' / _N*'2=/&84+ 4 * & &8 4) *% *' & _4/*%2%, =5*48% ,_ (STEL) ,& - 5%*5*4 *% ,5*4 *% / %4 *'4> &'*% & _,2:


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A84%& 10 !

B


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#ersonal #rotection !$uipment ##!" against dermal exposure

A*%'< * *,,8' L / 84

* 48&- 5%*+ @85,' 4 ' 5& =5*48%4 &' =5*48%4 %5%4''<


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%8 *% / /*%**%, 5%*8*' *% ' HCFC !! 5&'4 :% 4& 5%*8%4 &% +% 4% -&84 / &% ,5*4 - / 84 * +% *=

/*%' *% /%* - %&''< * :*%; &' &' * 84 PPE

*%% &' - 5%4*'& /irective

:)(24(


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G. STAKEHOLDERCONSULTATION

17 %'/ ,&'8&8%%4 &' 84%4 5&'4 '8'< pharmaceutics! pesticides! paper! and plastic industries$

H. OTHERINFORMATION

REFERENCES

R4; &4444,'> '+%*','& 5&% (8 !007> &*5 S5,-% !007)"

R4; &4444,' /8,&' /&/ 5&% (8' !00.)"

R4; &4444,' /8,&' /&/> &''= I 2 4:,,'< 5**4 (O*-% !00.)"

R4; %8*' 4%&

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