Harmonised classification and labelling previous targeted consultations

These targeted consultations for CLH proposals are closed. The consultations are launched in case further information is needed on a particular hazard class, or if comments are sought on e.g. a specific additional document.

The comments received during the consultation are available on the Registry of CLH intentions until outcome.

 

 
The proposal for the harmonised classification and labelling (CLH) of butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime; EC 202-496-6; CAS 96-29-7) was submitted by Germany (BAuA) and was subject to a public consultation, which ended on 4 September 2017. The relevant documents and comments received are published on ECHA website. During its forty-fifth meeting (June 2018), the Committee for Risk Assessment (RAC) discussed the proposed classifications for Eye Damage, Skin Irritation, Acute Toxicity (oral and dermal), Skin Sensitisation, STOT SE and Carcinogenicity. RAC further considered if the substance should also be classified for STOT RE. However, since STOT RE was not formally open for commenting during the public consultation, a targeted consultation is launched. butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime 202-496-6 96-29-7 Germany Acute Tox. 4*, H312,
Eye Dam. 1, H318,
Skin Sens. 1, H317,
Carc. 2, H351
Acute Tox. 3, H301,
Acute Tox. 4, H312,
Eye Dam. 1, H318,
Skin Sens. 1B, H317,
Carc. 1B, H350,
STOT SE 3, H336
dermal: ATE = 1848 mg/kg
oral: ATE = 100 mg/kg
Hexyl 2-(1-(diethylaminohydroxyphenyl)methanoyl)benzoate; hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate is used in cosmetics and personal care products.

The proposal for the harmonised classification and labelling (CLH) of hexyl 2-(1-(diethylaminohydroxyphenyl)methanoyl)benzoate; hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate was submitted by the German competent authority and was subject to a public consultation (PC), which ended on 12 January 2018. On 04 September 2018, industry has submitted new information, including two newly-conducted experimental studies on aquatic invertebrates.

Therefore, the purpose of this targeted PC is to receive information and comments on the relevance of the findings and the quality of these studies. All interested parties are invited to submit comments in direct relation to the subject of the targeted consultation via the commenting webform by 01 October 2018. The comments will be published on ECHA's website.
hexyl 2-(1-(diethylaminohydroxyphenyl)methanoyl)benzoate; hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate 443-860-6 302776-68-7 607-693-00-4 Germany Aquatic Chronic 4, H413 Aquatic Chronic 1, H410, M-factor = 1000
MCPA-thioethyl (CAS No. 25319-90-8) is an active substance used in plant protection products. The proposal for the harmonised classification and labelling (CLH) of MCPA-thioethyl was submitted by the Polish competent authority and was subject to a public consultation (PC), which ended on 7 April 2017.

The CLH report justifies the use of data from MCPA and other related substances to classify MCPA-thioethyl. During its December 2017 meeting (RAC-43), the Committee for Risk Assessment (RAC) asked for further information to clarify the potential for MCPA-thioethyl to cause toxicity relevant for the hazard class specific target organ toxicity - repeated exposure (STOT RE). After RAC-43, the ECHA Secretariat received from the applicant three repeated dose toxicity studies (Hellwig et al., 1995, conducted with MCPA-DMA salt; Sadlonova et al., 2006 conducted with MCPA; Muckova et al., 2005 conducted with MCPA) that were not included in the original CLH proposal. The complete Reuzel et al., 1980 study conducted with MCPA, which was initially included in the CLH report, is also provided in this PC for commenting.

The CLH report justifies the use of data from MCPA and other related substance During RAC-43, RAC did not discuss toxicity to reproduction as a research study (Roll and Matthiaschk, 1983 conducted with MCPA; in German) originally referred in the CLH dossier (but declared as being unavailable to the applicant) was made available to the Committee at a late stage of the process. This study is also within the scope of this public consultation, available in both its original version and as an English translation.

The CLH report justifies the use of data from MCPA and other related substance Two additional research studies published (Ujházy et al., 2006; Yasuda M. and Maeda H., 1972) may also contain relevant information for reproductive toxicity classification. ECHA Secretariat provides the abstracts of these research studies for which comments are welcome.

The CLH report justifies the use of data from MCPA and other related substance Therefore, the purpose of this targeted PC is to receive information and comments on the hazard classes STOT RE and reproductive toxicity of MCPA-thioethyl. Comments on the relevance of the findings and the quality of these studies will be highly appreciated.
The CLH report justifies the use of data from MCPA and other related substance

All interested parties are invited to submit comments in direct relation to the subject of the targeted consultation via the commenting webform by 31 January 2018. The comments will be published on ECHA's website.
MCPA-thioethyl (ISO); S-ethyl (4-chloro-2-methylphenoxy)ethanethioate; S-ethyl 4-chloro-o-tolyloxythioacetate 246-831-4 25319-90-8 246-831-4 Poland Acute Tox. 4, H302,
Aquatic Acute 1, M-factor=10,
Aquatic Chronic 1, M-factor=10
N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] 213-103-2 924-42-5 France Muta. 1B, H340,
Carc. 1B, H350,
STOT RE 1, H372
Pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc is used in the context of Regulation (EC) No 528/2012 as an active substance in Product Types 2, 6, 7, 9, 10 and 21, namely in disinfectants, can preservatives, antifouling products, rinse-off and leave-on cosmetic products.

The proposal for the harmonised classification and labelling (CLH) of Pyrithione zinc was submitted by the Swedish competent authority and was subject to a public consultation (PC), which ended on 07 July 2017.

Furthermore, due to the submission of additional information by the industry after the end of the public consultation, the proposal was subject to a targeted public consultation, which ended 21 March 2018.

On 11 May 2018, namely shortly before the June RAC meeting, the industry consortium has submitted new information, including two newly-conducted experimental studies on the marine diatom Skeletonema costatum. As the studies included preliminary results and were clearly marked by the industry as unaudited drafts, industry has committed to submit to the RAC audited, GLP-compliant full study reports for the two studies that could be placed under further public consultation.

As such, on 06/07/2018 and 13/07/2018, the industry consortium has indeed submitted the new information to ECHA on the aquatic toxicity of pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc.

Therefore, the purpose of this targeted PC is to receive information and comments on the relevance of the findings and the quality of these studies.

All interested parties are invited to submit comments in direct relation to the subject of the targeted consultation via the commenting webform by 01 August 2018. The comments will be published on ECHA's website.
pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc 236-671-3 13463-41-7 Sweden Acute Tox. 3, H301
Acute Tox. 2, H330
Eye Dam. 1, H318
Repr. 1B, H360D
STOT RE 1, H372
Aquatic Acute 1, H400
Aquatic Acute 1, M-factor=1000
Aquatic Chronic 1, H410
Aquatic Chronic 1, M-factor=10
The proposal for the harmonised classification and labelling (CLH) of pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc (EC 236-671-3; CAS 13463-41-7) was submitted by Sweden and was subject to a public consultation, which ended on 07/07/2017.

On 08/12/2017, the zinc pyrithione industry consortium has submitted new information to ECHA including an amendment to a final study report. Therefore, ECHA invites parties concerned to comment on the new information available on ECHA website in relation to the proposal by the DS to classify zinc pyrithione for developmental toxicity.

Parties concerned are invited to submit comments in direct relation to the subject of the targeted consultation via the commenting webform by 21/03/2018. The comments will be published on ECHA's website.
pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc 236-671-3 13463-41-7 Sweden Acute Tox. 3, H301,
Acute Tox. 2, H330,
Eye Dam. 1, H318,
Repr. 1B, H360D,
STOT RE 1, H372,
Aquatic Acute 1, H400,
M-factor=1000,
Aquatic Chronic 1, H410,
M-factor=10
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