News

New CLH public consultations launched on 11 proposals

ECHA/PR/13/08

ECHA is looking for comments on 11 harmonised classification and labelling (CLH) proposals, which include eight anticoagulant rodenticides,  two proposals for man-made vitreous fibres and one on an industrial chemical. The public consultations will be open for 45 days and will end on 19 April 2013.

Helsinki, 05 March 2013 – The CLH proposals for the eight anticoagulants have been submitted by eight different Member State competent authorities and concern the following substances: chlorophacinone, difenacoum, warfarin, difethialone, bromadiolone, coumatetralyl, brodifacoum and flocoumafen. These anticoagulants are all rodenticides and can also potentially be fatal to humans. They are being launched for public consultation at the same time as they act in a similar manner and are expected to have similar toxicological properties.

Chlorophacinone, difenacoum, warfarin and flocoumafen already have a harmonised classification and labelling listed in Part 3 of Annex VI to the CLP Regulation and revisions to the current classification for both health and environment hazards are being proposed. The other four rodenticides difethialone, bromadiolone, coumatetralyl and brodifacoum do not have a current Annex VI entry and the proposals also cover health and environmental hazards. Most of these substances have specific concentration limits related to one or more hazard classes.

CLH proposals on 475-glass special purpose fibres and E-glass special purpose fibres have been submitted by France. Both fibres are currently associated to fibres with an existing harmonised classification and labelling listed in Annex VI to the CLP Regulation. However, the dossier submitter is proposing new Annex VI entries with specific composition information, changes to notes and carcinogenicity classification.

The industrial chemical phenol, dodecyl-, branched has been submitted by an industrial company. The substance does not have an Annex VI entry and the proposal focuses only on reproductive toxicity. Another CLH proposal for the same substance by a different dossier submitter was submitted earlier to ECHA for which a public consultation ended on 1 February 2013. The category proposed for reproductive toxicity in this current proposal is more severe than in the previous submission.

The CLH proposals and the dedicated webform for posting comments are available on the ECHA website. The comments received during the public consultation will be regularly published on the ECHA website during the 45-day consultation phase.


Table 1. The proposed harmonised classification and labelling and examples of uses of the substances.

Substance name EC number CAS number Proposed harmonised classification and labelling Examples of uses*

 

chlorophacinone (ISO); 2-[(4-chlorophenyl)(phenyl)acetyl]-1H-indene-1,3(2H)-dione

223-003-0

3691-35-8

Acute toxicity

M-factors for hazards to the aquatic environment
Used as a biocidal active substance to control rodents.
difenacoum (ISO); 3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1- naphthyl)-4-hydroxycoumarin 259-978-4 56073-07-5

Acute toxicity

Reproductive toxicity

Specific target organ toxicity – repeated exposure (exposure routes)

Specific concentration limits (SCLs) for acute toxicity (only DSD), specific target organ toxicity - repeated exposure and for reproductive toxicity

M-factor/SCL for  hazard to the aquatic environment

Used as a biocidal active substance to control rodents.

warfarin (ISO); 4-hydroxy-3-(3-oxo-1-phenylbutyl)-2H-chromen-2-one 201-377-6 81-81-2

Acute toxicity

Specific concentration limits (SCLs) for specific target organ toxicity - repeated exposure and reproductive toxicity

Used as a biocidal active substance to control rodents. Warfarin's anticoagulant properties are also used in medications to prevent blood clots.

difethialone (ISO); 3-[3-(4'-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]-4-hydroxy-2H-1-benzothiopyran-2-one

- 104653-34-1

Acute toxicity

Specific target organ toxicity – repeated exposure

Reproductive toxicity

Hazardous to the aquatic environment

Specific concentration limits  (SCLs) for acute toxicity (only DSD), specific target organ toxicity -repeated exposure  and for reproductive toxicity

M-factor/SCL for hazard to the aquatic environment
Used as a biocidal active substance to control rodents.

bromadiolone  (ISO); 3-[3-(4'-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H-chromen-2-one

249-205-9

28772-56-7

Acute toxicity

Reproductive toxicity

Specific target organ toxicity – repeated exposure

Hazardous to the aquatic environment

Specific concentration limits(SCLs)  for acute toxicity (only DSD), specific target organ toxicity – repeated exposure and for reproductive toxicity

M-factor/SCL for hazard to the aquatic environment
Used as a biocidal active substance to control rodents.
coumatetralyl (ISO); 4-hydroxy-3-(1,2,3,4-tetrahydro-1- naphthyl)coumarin 227-424-0

5836-29-3

Acute toxicity

Reproductive toxicity

Specific target organ toxicity – repeated exposure (organ specification)

Hazardous to the aquatic environment

Specific concentration limits (SCLs) for specific target organ toxicity - repeated toxicity and reproductive toxicity

M-factor for hazard to the aquatic environment
Used as a biocidal active substance to control rodents.
brodifacoum (ISO); 4-hydroxy-3-(3-(4'-bromo-4-biphenylyl)- 1,2,3,4-tetrahydro-1-naphthyl)coumarin 259-980-5  

56073-10-0

Acute toxicity

Reproductive toxicity

Skin sensitisation

Specific concentration limits (SCLs) for acute toxicity (only DSD) and for specific target organ toxicity -repeated exposure  

M-factors/SCL for hazards to the aquatic environment
Used as a biocidal active substance to control rodents.
flocoumafen (ISO); reaction mass of: cis-4-hydroxy-3-(1,2,3,4- tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin; trans-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4- (4-trifluoromethylbenzyloxy)phenyl)-1- naphthyl)coumarin 421-960-0

90035-08-8

Acute toxicity

Reproductive toxicity

Specific target organ toxicity – repeated exposure (exposure routes)

Specific concentration limits (SCLs) for acute toxicity (only DSD), specific target organ toxicity- repeated exposure  and for reproductive toxicity 

M-factor/SCL for hazard to the aquatic environment
Used as a biocidal active substance to control rodents.

special purpose 475-glass fibres [Calcium-aluminium-silicate fibres with random orientation with the following composition (% given by weight): SiO2 55.0-60.0%, Al2O3 4.0-7.0%, B2O3 8.0-11.0%, Na2O 9.5-13.5%, K2O 1.0-4.0%, CaO 1.0-5.0%, MgO 0.0-2.0%, Fe2O3 <0.2%, ZnO 2.0-5.0%, BaO 3.0-6.0%, F2 <1.0% with note R. Process: drawing or spinning the molten mix (at approx. 1500°C) from nozzles]

- -

Carcinogenicity

Note R
Special purpose 475-glass fibres are used in industrial and domestic applications such as air or liquid filtration and purification.

special purpose E-glass fibres [Calcium-aluminium-silicate fibres with random orientation with the following composition (% given by weight): SiO2 50.0-56.0%, Al2O3 13.0-16.0%, B2O3 5.8-10.0%, Na2O <0.6%, K2O <0.4%, CaO 15.0-24.0%, MgO <5.5%, Fe2O3 <0.5%, F2 <1.0% with note R. Process: drawing or spinning the molten mix (at approx. 1500°C) from nozzles]

- -

Carcinogenicity

Note R
Special purpose E-glass fibres are used in industrial and domestic applications such as air or liquid filtration and purification.
Phenol, dodecyl-, branched 310-154-3 121158-58-5

Reproductive toxicity

Specific concentration limit (SCL) for reproductive toxicity
The substance is synthesised and used under predominantly closed industrial chemical processes. The only registered use is in the chemical industry as an intermediate/monomer for the synthesis of higher molecular weight substances and polymers. The substance is not supplied to the general public.

*Please note that information on uses does not impact the harmonised classification and labelling, which is solely based on the intrinsic properties of a substance. Examples of uses are copied from the CLH report.