Meeting of experts: cymoxanil
11 June 2012 | ECHA, Helsinki | Registration until 1 May
ECHA organises a meeting of experts to discuss the reproductive toxicity and the repeated dose toxicity of cymoxanil (EC No 261-043-0, CAS No 57966-95-7) in the context of the proposal for the harmonisation of the classification and labelling (CLH) of cymoxanil at EU level.
The Committee for Risk Assessment (RAC) is currently assessing the proposal. After consultation with the Committee, ECHA has decided to give the parties concerned an opportunity to nominate experts to discuss specific scientific questions related to the classification of cymoxanil for reproductive toxicity and for specific target organ toxicity.
The meeting will exclusively focus on the following questions identified by RAC:
- Do the effects seen on male reproductive organs in repeated dose studies summarised in the CLH report provide evidence for adverse effects of cymoxanil on sexual function and fertility?
- Do the haematology (Tompkins, E. C. 1993) and thymus atrophy (Venugopala, K.1999) effects observed in 90-day dog studies, along with the effects on the eye (retina and lenticular degeneration seen in a two-year rat and one-year dog study (Cox, L. R. 1994 and Teunissen, 2003, respectively)), constitute significant toxic effects of cymoxanil after repeated exposure?
The discussion will be about the scientific interpretation of the studies mentioned in the references above, and it will be based on the material already available to RAC via the CLH proposal and the public consultation.
At the expert meeting, no decisions regarding the harmonisation of the classification and labelling of cymoxanil will be taken. Nevertheless, RAC will assess the outcome of the discussions during the opinion development process.
Any information outside the scope of the questions above will not be discussed. ECHA will publish the outcome of the meeting on the ECHA website.
The proposal for harmonised classification and labelling of cymoxanil was submitted by Austria in June 2011, and the following public consultation ended on 29 July 2011.
During the public consultation and at subsequent RAC meetings, some concerns were raised on the appropriateness of the classification proposal and whether classification for reproductive toxicity and specific target organ toxicity was justified. Such concerns specifically referred to the effects on male reproductive organs in repeated dose toxicity studies and whether these justified classification for reproductive toxicity for adverse effects on sexual function and fertility.
Additional concerns were raised regarding the effects on haematology, thymus and eyes in repeated dose toxicity studies in dogs, and whether these justified classification for specific target organ toxicity.
Parties concerned can nominate an expert to take part in this meeting, either directly or via their stakeholder organisation. The nominated experts will present their views on the key questions during the meeting and respond to any follow-up questions from RAC members.
The experts should submit their input to the key questions in writing by 21 May.
The RAC rapporteurs for cymoxanil and other interested RAC members and their invited experts will also attend the meeting. The meeting will be moderated by a member of the ECHA Secretariat and meeting notes will be produced.
If you consider yourself as a party concerned, you are encouraged to coordinate your involvement via a stakeholder organisation, such as trade and industry associations and NGOs, that may help you to identify the appropriate expert to represent you in the meeting. Find in this document the list of ECHA's accredited stakeholder organisations.
Nominated experts may register to the meeting by sending an email to ECHA by 1 May. This email should include:
- A brief statement on why the party in question is considered as a party concerned
- The name and contact details of the nominated expert
- The identity of the parties concerned that the nominated expert is representing at the meeting
- From the list of the aforementioned specific key questions, the questions that will be addressed in the written input and presentation at the meeting.
The registered experts should submit their written input to the key questions and their presentations by 21 May 2012 via the same email address. It should include an abstract of a maximum of 250 words that summarises the response to the key questions. After registration, the nominated experts will receive more details on the required written input via email.
ECHA will not reimburse any costs associated with attendance to the meeting, including travelling costs, accommodation or daily subsistence.
The personal data submitted to the Agency will be solely used for the purpose of organising the CLH expert meeting. The outcome of the meeting, including the list of participants, will be published on the ECHA website. Please note that the European Chemicals Agency will ensure on its part that your personal data is processed as required by Regulation (EC) No 45/2001 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data. You have the right to access and rectify that data. To exercise these rights, please contact the data controller at clh-expert-meetings (at) firstname.lastname@example.org.
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