EUROPEAN COMMISSION
DIRECTORATE GENERAL JRC
JOINT RESEARCH CENTRE
Institute for Health and Consumer Protection
Unit: Toxicology and Chemical Substances
European Chemicals Bureau

 

 

 

ECBI/146/04 Rev. 2

11 February 2005

 

DRAFT AGENDA

Technical Committee on
Classification and Labelling of Dangerous Substances

 

Meeting on Health Effects of Pesticides, Existing Chemicals, New Chemicals and General issues

 

Arona, 15-18 March 2005

The meeting will start 15 March at 13.00h

and finish 18 March at 16.00h

 

 

 

Documents received after the deadline of 4 February will not be added to the agenda. They can be presented at the meeting and will be distributed to the TC C&L in the follow up period of the meeting.

 

 

Color coding:

 

Priority Discussion due to CMR endpoints

Will not be discussed if time is limited

            

 

 

 

1.         Adoption of the draft agenda (ECBI/146/04 Rev. 1)

 

 

Part I, Pesticides

(Tuesday 15 March 13.00h to Wednesday 16 March 10.30h)

 

 

2.         Previous Meetings

 

2.1

 Adoption of the draft summary record of the of Health 

 meeting 21-24 September 2004, Part I on Pesticides  

Was distributed by email on 28 January 2005

2.2

Report back from the Specialised Experts meeting on Procymidone of 6 October 2004.

 

(The C&L experts are asked if they can accept the conclusions from this meeting, see also agenda point 3.1)

ECBI/132/04 Rev. 2

 

(Summary Record)

 

 

3.       Continued discussion of existing pesticides  

       

    3.1    Pesticides reviewed under Directive 91/414/EEC

 

P586

 

Procymidone (FR)

Issue for discussion: Outcome of the SE meeting on reproductive toxicity.

 

Experts are asked to consider the new studies from IND, Adds 40, 41, 42, 43 and 44

 

EC: 251-233-1

 

ECBI/94/02 and Adds. 1,  2 (MS only), 3, 4, 5, 6 (MS only), 7 and 8.

ECBI/94/02 Adds. 9, 10, 11, 12, 13, 14 and 15 (MS only).

 

Publications with Add. 11:

ECBI/94/02 Adds 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35 and 36

 

ECBI/94/02 Add. 37 and 38

ECBI/94/02 Adds. 39, 40, 41 (MS only), 42, 43, 44 and 45 parts I and II and 46 parts I and II (MS only).

P517

Tolylfluanid (FIN)

Issue for discussion: definition of the entries in Annex I 

613-116-00-7

EC: 211-986-9

CAS: 731-27-1

ECBI/36/98 Adds. 11 (I and II), 12, 13 (I, II, III), 14 and 15

P372

Maneb (IT)

Issues for discussion: reprotoxicity based on the outcome of the Specialised Experts meeting in February 2005 and R42 pending the discussion on HMT in the TC NES

006-077-00-7

EC: 235-654-8

CAS: 12427-38-2

ECBI/89/02, Add. 1, 3, 4,  5,  6, 7, 9, 14 (III), 17, 18, 19, 20, 24, 25

 

ECBI/140/04, Add. 1 and 2

 

ECBI/02/05 (conclusions SE meeting)

 

HMT documentation:  Classification proposal 1990, XI/202/91 Add. 3, XI/202/91 Com. 5, IUCLID datasheet

P371

Mancozeb (IT)

Issues for discussion: reprotoxicity based on the outcome of the Specialised Experts meeting in February 2005 and R42 pending the discussion on HMT in the TC NES

006-076-00-1

CAS: 8018-01-7

ECBI/89/02 and Adds. 1, 3, 10, 11, 12, 13, 14 Parts I, II and III, 21, 22, 23, 26 and 27 (MS only)

ECBI/164/04 Add. 8 (MS only)

ECBI/02/05 (conclusions SE meeting)

HMT documentation:  Classification proposal 1990, XI/202/91 Add. 3, XI/202/91 Com. 5, IUCLID datasheet

P565

Glufosinate ammonium (S)

Issues for discussion: reprotoxicity based on the outcome of the Specialised Experts meeting in February 2005, and acute and long term toxicity by inhalation pending the general discussion on how to classify substances that may form aerosols

015-155-00-X

EC: 278-636-5 CAS: 77182-82-2

ECBI/53/03, Add.1, 2 (I, II, III, IV, V, VI) (MS only), 3, 4, 5, 6 and 7 (MS only), 8, 9, 10, 11, 12, 13 and 14 (MS only), and 15

 

ECBI/02/05 (conclusions SE meeting)

P315

Diuron (DK)

Issues for discussion: Long term toxicity and sensitisation. 

006-015-00-9

EC: 206-354-4

CAS: 330-54-1

ECBI/44/04, Add. 1,  2, 3, 4, 5,  6 (90-day feeding study in rats) and 7

 
P135

Malathion (FI)

Issue for discussion: final classification proposal to be confirmed at this meeting when the outcome of the  EPCO meeting in January/February 2005 will be available.

015-041-00-X

EC: 204-497-7

CAS: 121-75-5

 ECBI/100/04
P530 Clopyralid (FI)

Issue for discussion: final classification proposal to be confirmed at this meeting when the outcome of the evaluation meeting at EFSA will be available.

607-231-00-1

EC: 216-935-4

CAS: 1702-17-6

 ECBI/99/04 and Add. 1

 

 

    3.2    Existing pesticides not reviewed under Directive 91/414/EEC

 

P607

Sulfur (FR)

Issues for discussion: Specific concentration limits for R43

EC: 231-722-6

CAS: 7704-34-9

ECBI/46/04, Add. 1, 2 (MS only), 3, 4, 5, 6, 7, 8 ,  9 , 10 , 11 , 12 , 13 , 

(MS only) , 14 , 15 ,  16 and 17 (MS only).

P171

Phoxim (NL)

Issue for discussion:

Reprotoxicity both fertility and development

015-100-00-X

EC: 238-887-3

CAS: 14816-18-3

ECBI/40/04, Add. 1 and 2

ECBI/06/05

E003

Benzyl Benzoate (NL)

Issue for discussion: Sensitisation (R43)

607-085-00-9

EC: 204-402-9

CAS: 120-51-4

ECBI/03/04 and  Add. 1

Data on skin sensitisation awaited from IND 

 

 

4.        First discussions of existing pesticides

 

    4.1        Pesticides reviewed under Directive 91/414/EEC

 

P621

Metconazole (BE)

Issues for discussion: Acute toxicity and Reprotoxicity

CAS: 125116-23-6

ECBI/152/04, Add. 1, 2, 3, 4, 5, 6 and 7

ECBI/06/05
P029

Carbofuran (BE)

Issues for discussion: Acute toxicity, irritancy and Reprotoxicity

006-026-00-9

EC: 216-353-0

CAS: 1563-66-2

 ECBI/157/04 and Add. 1
P623

Clodinafop-propargyl (NL)

Issues for discussion: Acute toxicity and sensitisation

CAS: 105512-06-9

 ECBI/155/04 and Add. 1

ECBI/06/05

P594

Phosalone (AT)

Issues for discussion: Acute toxicity and sensitisation

015-067-00-1

EC: 218-996-2

CAS: 2310-17-0

ECBI/158/04 and Rev. 1
P522

Benfuracarb (BE)

Issues for discussion: Acute toxicity

006-088-00-7

CAS: 82560-54-1

 ECBI/153/04 and Add. 1
P527

Carbosulfan (BE)

Issues for discussion: Keep current Annex I classification for acute toxicity and sensitisation

006-084-00-5

EC: 259-565-9

CAS: 55285-14-8

 ECBI/156/04 and Add. 1
P592

Pyrimethanil (AT)

Issues for discussion: No classification for health effects

CAS: 53112-28-0

 ECBI/159/04
P593

Triticonazole (AT)

Issues for discussion: No classification for health effects

CAS: 131983-72-7

 ECBI/160/04
P622

Trinexepac-ethyl (NL)

Issue for discussion: No classification for health effects

CAS: 95266-40-3

 ECBI/154/04

 

   

5.        Discussion on re-opening of evaluation of concluded existing pesticides

 

P086a

Dinocap [1]

Issues for discussion: Reproductive toxicity of new dinocap isomer, dinocap - 6M [2]

 

This substance will be discussed under agenda point 6

609-023-00-6 [1]

EC: 254-408-0 [1]

CAS: 39300-45-3 [1]

CAS: 131-72-6 [2]

 ECBI/05/05 (MS only)

 

 

6.       Discussion on Pesticides notified under Directive 91/414/EEC.

          Confidential agenda point, Member States’ experts and Notified

          Representatives only (ECBI/146/04 Add. 1)

 

 

 

                                              Part II, General Issues

(Wednesday 16 March, 11.00h to 13.00h)

 

 

7.         Previous Meetings

 

7.1

 Adoption of the draft summary record of the of Health 

 meeting 21-24 September 2004, Part II on General Issues  

Was distributed by email on 28 January 2005

 

 

8.       Meeting of the Physico Chemical Experts in Leverkusen January 2005

 

8.1

Report back from the Meeting of the Physico Chemical Experts in Leverkusen January 2005, and discussion of the documents.

 

Summary of the meeting

 

ECBI/15/05 (proposal sent to the DPD meeting on 7 February 2005)

 

 

9.      Criteria related issues

 

9.1

General discussion on classification of substances that may emerge as aerosols.

 

General discussion:

ECBI/05/01 (I, II), Add. 1 and 2

 

ECBI/08/03,

 

ECBI/60/03, Add. 1   (part I) and 2

9.2

Discrepancy in the text of the criteria for 'Ocular lesions'

ECBI/166/04

9.3

Parental toxicity/Reprotoxicity potency

Discussion of the discussion paper for the Adhoc expert meeting of 7-8 April 2005

ECBI/30/04 and

ECBI/30/04 Add. 1, Add. 2 and Add. 3

 

 

10.      Issues related to the interim strategy and REACH

 

10.1

Report back from meeting on RIP 4.4

 

10.2

 Preparation of classification proposals in accordance with Annex XIV ECBI/12/05 and Add.1

 

 

11.      Any Other Business

 

11.1

Follow-up of the meeting and planning for the next meeting of the Group

 

 

 

- Classification and Labelling of Biocides

Substances on the waiting list

Substances to be discussed

 

ECBI/13/05 (for info)

 

 

 

Part III, Existing substances

(Wednesday 16 March 14.00h to Thursday 17 March 18.00h)

 

12.         Previous Meetings

             

12.1

Adoption of the draft summary record of the of Health 

meeting 21-24 September 2004, Part III on Existing substances  

Was distributed by email on 28 January 2005

 

 

13.         Classification of Existing substances subject to the common written procedure between

              TC NES and TC C&L 

 

       Please note that the individual comments of MS and IND were already distributed to you by e-mail therefore they are not posted on the Agenda!

                          ECBI/29/04 Rev. 3 (Cooperation TCNES TC C&L)

 ECBI/141/04 Rev. 4  Final Summary of proposals and comments

(Status February 2, 2005)

F040

2-methoxy-1-methylethyl acetate, PGMA (FR)

Issue for discussion: Depending on the outcome of the written procedure*

607-195-00-7

EC: 203-603-9

CAS: 108-65-6

 ECBI/125/04, Rev. 1

 ECBI/11/05
F041

1-methoxy-2-propanol, PGME (FR)

Issue for discussion: Depending on the outcome of the written procedure*

603-064-00-3

EC: 203-539-1

CAS: 107-98-2

 ECBI/126/04

ECBI/11/05
F042

Tris(nonylphenyl)phosphite, TNPP (FR)

Issue for discussion: Depending on the outcome of the written procedure*

EC: 247-759-6

CAS: 26523-78-4

 ECBI/127/04

IRL001

Tris[2-chloro-1-(chloromethyl)ethyl] phosphate, TDCP (IRL)

Issue for discussion: Depending on the outcome of the written procedure*

EC: 237-159-2

CAS: 13674-87-8

ECBI/129/04  and

 

 Rev.1

 

ECBI/141/04 Add.3 

IRL002

Tris(2-chloro-1-methylethyl) phosphate, TCPP (IRL)

Issue for discussion: Depending on the outcome of the written procedure*

EC: 237-158-7

CAS: 13674-84-5  

ECBI/128/04  and

 

 Rev. 1

 

ECBI/141/04 Add.3 

IRL003

2,2-bis(chloromethyl) trimethylene bis[bis(2-chloroethyl) phosphate], V6 (IRL)

Issue for discussion: Depending on the outcome of the written procedure*

EC: 253-760-2 

CAS: 38051-10-4

 ECBI/130/04  and

 Rev. 1

ECBI/141/04 Add.3 

 

                * The written procedure was finalised on 21 February 2005. All comments

                have been integrated in the table.

 

14.       Continued discussion of Existing substances

 

    14.1     Classification of Existing substances discussed in the TC NES

 

Q009a

Salts of Piperazine (SE):

Piperazine hydrochloride [1]

Piperazine dihydrochloride [2]

Piperazine phosphate [3]

Issue for discussion: Inclusion of R36 in the agreed classification from September 2004

EC: 228-042-7 [1]

       205-551-2 [2]

       217-775-8 [3]

CAS: 6094-40-2 [1]  

         142-64-3 [2]

         1951-97-9 [3]

 

ECBI/39/03 Rev. 1, Add. 1 (I, II), 2, 3 (I, II, III, IV) (MS only), 4 and 5
M010

2,3-epoxy-propyl-trimethyl ammoniumchloride...% (FIN)

(EPTAC...%)

Issue for discussion: Mutagenicity

EC: 221-221-0  

CAS: 3033-77-0

 ECBI/13/03 Rev. 1 and Add. 1

K050

Hydroxylammonium salts (D):

Hydroxylammonium hydrogensulfate [1]

Hydroxylamine Phosphate [2]

Hydroxylamine Dihydrogenphosphate [3]

Hydroxylamine 4-Methylbenzenesulfonate [4]

Issue for discussion: Check the salts to be covered besides [1] which was already included in the draft 30th ATP and whether they all trigger the same classification as [1] for acute toxicity and irritancy.

CAS: 10046-00-1 [1]

          20845-01-6 [2]

          19098-16-9 [3]

          53933-48-5 [4]

EC:  233-154-4 [1]

        244-077-0 [2]

        242-818-2 [3]

        258-872-5 [4]

ECBI/14/03 Add. 7 , 8  and 9

 

ECBI/16/03 and Add. 1 (I,II)

 

 

    14.2     Classification of Existing substances not subject to Risk Assessment

 

C089

Cobalt oxide

Issue for discussion: On basis of document ECBI/65/03 Add. 17 it should be discussed whether this entry should be revised to include also Co2O3 (CAS No: 1308-04-9), Co3O4 (CAS No: 1308-06-1) and Note 1.

027-002-00-4

EC: 215-154-6

CAS: 1307-96-6

ECBI/65/03 Add. 17
C090

Cobalt sulfide

Issue for discussion: On basis of document ECBI/65/03 Add. 17 it should be discussed whether this entry should be revised to include also CoS2 (CAS No: 12013-10-4) and Note 1.

027-003-00-X

EC: 215-273-3

CAS: 1317-42-6

 ECBI/65/03 Add. 17

U077

Ammonium perchlorate

Issue for discussion: Final definition of the entry(ies) and whether Note T would apply on the basis of the advice from the Physico Chemical Expert group.

017-009-00-0

EC: 232-235-1

CAS: 7790-98-9

 ECBI/16/04
F034

1-methyl-2-pyrrolidone

Issue for discussion: Specific concentration limits for reprotoxicity

606-021-00-7

EC: 212-828-1

CAS: 872-50-4

ECBI/47/02 Rev. 1, Add. 1, 2, 3, 4, 5 (Complete studies can be requested from B. Machin), 6, 7, 8, 9, 10, 11, 12 , 13  and 14
Y009

Octamethylcyclotetrasiloxane

Issue for discussion: Results from new 2-year bioassay.

014-018-00-1

EC: 209-136-7

CAS: 556-67-2

 ECBI/37/98 Add. 11 (I, II), 12, 13, 14 , 15 and

 16 and 17 (for further info contact Mr. de Poortere (CES) or B. Machin)
U072

Furfuryl alcohol

Issues for discussion: Irritancy and long term toxicity

603-018-00-2

EC: 202-626-1

CAS: 98-00-0

ECBI/71/04 and Adds. 2 , 3 and 4 (MS only)

U072a

Furfuryl Esters:

Furfuryl acetate [1]

Furfuryl propionate [2]

Furfuryl pentanoate [3]

Furfuryl octanoate [4]

Furfuryl 3-methylbutanoate [5]

Issues for discussion: All endpoints that were discussed for furfuryl alcohol.

EC: 210-775-9 [1]

       210-776-4 [2]

       254-381-5 [4]

CAS:  623-17-6 [1]

           623-19-8 [2]

       39252-03-4 [4]

ECBI/71/04, Add. 1

(see also the full document) , 2 , 3 

 

and  4 (MS only)

 

 

 

15.      First discussions  

 

15.1     Classification of Existing substances discussed in the TC NES

  

U035

 

Tris(2-chloroethyl)phosphate, TCEP

Issues for discussion: Carcinogenicity, reprotoxicity and acute toxicity

015-102-00-0

EC: 204-118-5

CAS: 115-96-8

 

 

ECBI/161/04, Add. 1 and Add. 2 parts I and II

L012

AHTN (NL)

1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one

Issues for discussion: Irritancy and sensitisation

CAS No. 1506-02-1

EC No. 216-133-4

 

ECBI/92/04 and

Adds. 1 Rev. 1,

3 Rev. 1, 4, 5, 6, 7, 9 , 10 and 11

 

(Adds 2 and 8 were withdrawn by Industry)

G001

Anthracene (EL)

Issue for discussion: Irritancy

CAS: 120-12-7

EC: 204-371-1

ECBI/95/04 Rev. 1 and Add. 1

L011

HHCB (NL)

1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylindeno(5,6-c)pyran

Issue for discussion: Irritancy

CAS No. 1222-05-5

EC No. 214-946-9

ECBI/91/04 and Add. 1

U076

Tetrabromobisphenol-A (UK)

Issues for discussion:

 

ECBI/07/05

I060

Sodium hypochlorite (IT)

Issue for discussion: Acute toxicity

017-011-00-1

CAS No. 7681-52-9 EC No. 231-668-3

 ECBI/14/05

M011

2 Methoxy-2-methylbutane, TAME (FIN)

CAS No. 994-05-8

ECBI/08/05 and Add.1

A041

Perboric acid, sodium salt

monohydrate and tetrahydrate (AT)

Issues for discussion: Report back from the Specialised Experts meeting on Reprotoxicity of 5-6 October 2004.

 

Endpoints to be discussed are depending on the AT C&L proposal.

EC No. 234-390-0 CAS No. 11138-47-9

ECBI/38/03 Add.1 and Add. 2

 

ECBI/132/04 Rev. 2

(Summary Record from the SE meeting)

 

 

 

15.2        Classification of Existing substances not subject to Risk Assessment

 

                Discussion on Nickel compounds foreseen Thursday after lunch!

 

C042

Nickel monoxide (NiO) [1]

Nickel oxide [2]

Bunsenite [3]

Issues for discussion: Long term toxicity and respiratory sensitisation

028-003-00-2 [1]

EC: 215-215-7 [1]

       234-323-5 [2]

CAS: 1313-99-1 [1]

        11099-02-8 [2]

        34492-97-2 [3]

ECBI/96/04

C043

Nickel dioxide (NiO2)

Issues for discussion: Long term toxicity and respiratory sensitisation

028-004-00-6

EC: 234-823-3

CAS: 12035-36-8

ECBI/96/04

C044

Nickel trioxide (Ni2O3)

Issues for discussion: Long term toxicity and respiratory sensitisation

028-005-00-3

EC: 215-217-8

CAS:1314-06-3

ECBI/96/04

C045

Nickel sulfide (NiS) [1]

Nickel sulfide [2]

Millerite (NiS) [3]

Issues for discussion: Mutagenicity, reprotoxicity, long term toxicity, respiratory sensitisation.

028-006-00-9 [1]

EC: 240-841-2 [1]

       234-349-7 [2]

CAS: 16812-54-7 [1]

          11113-75-0 [2]     

            1314-04-1 [3]

ECBI/96/04

C046

Nickel subsulfide (Ni3S2) [1]

Heazlewoodite [2]

Issues for discussion: Mutagenicity, reprotoxicity, long term toxicity, respiratory sensitisation.

028-007-00-4 [1]

EC: 234-829-6 [1]

CAS: 12035-72-2 [1]

         12035-71-1 [2]

ECBI/96/04

C046b

Nickel dihydroxide (Ni(OH)2) [1]

Nickel hydroxide [2]

Issues for discussion: Carcinogenicity, Mutagenicity, reprotoxicity, long term toxicity, irritancy, respiratory sensitisation.

028-008-00-X

EC: 235-008-5 [1]

       234-348-1 [2]

CAS: 12054-48-7 [1]

          11113-74-9 [2]

ECBI/96/04

N001

4-tert-octylphenol

(4-(1,1,3,3-tetramethylbutyl)phenol)

Issues for discussion: Irritancy and reprotoxicity.

EC: 205-426-2

CAS: 140-66-9

ECBI/108/04 and 

 

Rev.1 and 

 

Adds. 3 and 4

Q010

Vanadium pentoxide

Issues for discussion: Carcinogenicity and mutagenicity.

023-001-00-8

EC: 215-239-8

CAS: 1314-62-1

ECBI/112/04

and Adds. 1 , 2 , 3 ,  4, 5 , 6, 7 , 8

D129

2-ethylhexyl-2-ethylhexanoate

Issue for discussion:  Reprotoxicity.

EC: 231-057-1

CAS: 7425-14-1

ECBI/110/04

U075

Phenolphthalein

Issues for discussion: Carcinogenicity, mutagenicity and reprotoxicity.

EC: 201-004-7

CAS: 77-09-8           

ECBI/113/04

I044

Diisobutyl phthalate

Issue for discussion: Reprotoxicity

EC: 201-553-2

CAS: 84-69-5

 ECBI/116/04 and 

 Rev.1

W021

o-cresyl glycidylether (o-CGE)

[(p-tolyloxy)methyl]oxirane [1]

[(m-tolyloxy)methyl]oxirane [2]

o-cresyl glycidylether (o-CGE); 2,3-epoxypropyl o-tolyl ether [3]

[(tolyloxy)methyl]oxirane; cresyl glycidyl ether [4]

 

Issue for discussion: Mutagenicity

603-056-00-X

 

CAS No

2186-24-5 [1]

2186-25-6 [2]

2210-79-9 [3]

26447-14-3 [4]

 

EC No

218-574-8 [1]

218-575-3 [2]

218-645-3 [3]

247-711-4 [4]

ECBI/93/04 and Adds. 1, 2, 3 and 4

 

 

 

                                       

                                                              Part IV, New Substances

(Friday 18 March from 9.00h to 16.00h)

  

    

16.         Adoption of the draft agenda for the new substances session

  

17.         Previous Meetings

             

17.1

Adoption of the draft summary record of the 18th Working Group Meeting in Arona, September 25, 2004   

Distributed by email on 16 December 2004

  

 

 18.       Substances ready for TPC

 18.1

List 1.1: M19  L1.1 classification agreed at the 18th meeting                   

 

 18.2

List 1.2: M19  L1.2 classification agreed for HH and the environment in the 15th sending

 

            

 19.       Discussion of substances - Classification and Labelling for Human Health Effects

 19.1

List 3.1: M19  L3.1 classification not agreed at the 18th meeting

Distributed by email on 16 December 2004     

 19.2

List 3.2: M19  L3.2 classification not agreed in the 15th sending

 

 19.2

List 3.3: M19  L3.3 substances proposed by MS

 

            

  20.       Any other business (new substances)

  

 20.1

 Follow-up of the meeting and planning for the next meeting of the Group