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Registry of CLH intentions until outcome

Registry of CLH intentions until outcome

The registry of classification and labelling (CLH) intentions until outcome lists the intentions and proposals received by ECHA for a new or revised harmonised classification and labelling of a substance. The proposals are submitted by Member State competent authorities, manufacturers, importers or downstream users.  

Interested parties can follow the progress of a proposal through the CLH process, from the notification of the intention to the adoption of the opinion of the Committee for Risk Assessment (RAC). The advance notice enables interested parties to plan and prepare for commenting later on.

Anyone with relevant information on the identity or hazard properties of a substance is encouraged to provide this information to the dossier submitter during the early stages of the process, or at the latest during the public consultation.

Where an opinion has been adopted by RAC, the status is indicated as ‘Opinion Adopted’.

Note: The classification tables for those substances that have been reviewed are listed in the ‘Corrigenda to the RAC opinions’ document.

spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine

EC / List no: 601-505-4 CAS no: 118134-30-8
CLP Annex VI Index number
612-150-00-X
Further substance information
Status
Opinion Adopted
Date of intention
Expected date of submission
Submitted for accordance check
24/04/2015
Final submission date
28/04/2015
Withdrawal date
Legal deadline for opinion adoption
27/10/2016
Submitter
Germany
Submitter's email
Harmonised classification at the time of the proposal
Acute Tox. 4*, H302
Acute Tox. 4*, H312
Acute Tox. 4*, H332
Skin Irrit. 2, H315
Skin Sens. 1, H317
Aquatic Acute 1, H400
Aquatic Chronic 1, H410
Specific concentration limits at the time of the proposal
Proposed harmonised classification by the dossier submitter
Acute Tox. 4, H302
Acute Tox. 4, H312
Acute Tox. 4, H332
Skin Irrit. 2, H315
Skin Sens. 1B, H317
Repr. 2, H361d
STOT RE 2, H373
Aquatic Acute 1, H400
Aquatic Acute 1, M-factor=100
Aquatic Chronic 1, H410
Aquatic Chronic 1, M-factor=100
Proposed specific concentration limits by the dossier submitter
The changes to the classification for acute toxicity, skin sensitisation, reproductive toxicity and environment (M-factors), as presented above are currently under discussion by RAC based on a previous proposal. A link to the previous public consultation of the previous proposal, including the CLH report, is available here:
http://echa.europa.eu/harmonised-classification-and-labelling-previous-consultations/-/substance-rev/3259/term
Regulatory programme
Active substance in Plant Protection Products
Remarks
Start of consultation
05/05/2015
Deadline for commenting
04/06/2015
Hazard classes open for commenting
Specific target organ toxicity — repeated exposure*

*if the data on repeated dose toxicity is considered to influence the other human health hazard classes currently under discussion by RAC (i.e. acute toxicity,
respiratory/skin sensitization and
reproductive toxicity), comments may also be provided on these hazard classes.
CLH report
Annexes to the CLH report
Date of opinion
11/09/2015
RAC Opinion
Background document
RCOM (Comments received)
Attachments received during public consultation (excluding journal articles)
Minority opinion(s)
Other annexes
ATP number and date
ATP10 - (04/05/2017), 01/12/2018
Link to ATP
Latest update
02/04/2019

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