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.
Some concerns were raised on the appropriateness of the classification proposal, and now ECHA organises a meeting of experts to discuss the reproductive toxicity and the repeated dose toxicity of cymoxanil.
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.
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.