EFSA Seeks Feedback on Overhaul of Weight of Evidence and Biological Relevance Guidance
EFSA launches consultation on updating its Weight of Evidence and Biological Relevance guidance, aiming to streamline chemical risk assessment practices.
The European Chemicals Agency (ECHA) has launched a public consultation as part of its harmonised classification and labelling (CLH) process for 3,4-dimethyl-1H-pyrazole (3,4-DMP), a chemical substance commonly used in various industrial applications. This consultation seeks to gather further insights on the reproductive toxicity of the substance, particularly in relation to its analogue, 3,4-dimethyl-1H-pyrazol-1-ium dihydrogen phosphate (3,4-DMPP). The consultation is open until 25 September 2024.
Key Insights
Background on the Substance
The current classification of 3,4-DMP in Annex VI of the Classification, Labelling and Packaging (CLP) Regulation includes:
- Acute Toxicity Category 4 (Oral): H302
- Serious Eye Damage Category 1: H318
- Aquatic Chronic Toxicity Category 3: H412
Belgium, the dossier submitter, has proposed expanding this classification to include additional hazards, such as Acute Dermal and Inhalation Toxicity (H312, H332), Carcinogenicity (H351), Reproductive Toxicity (H361f), and Specific Target Organ Toxicity (H373). These proposed changes aim to ensure the safe use and handling of the substance by industrial operators.
Focus of the Current Consultation
During the RAC-70 CLH working group meeting in July 2024, experts highlighted significant similarities between 3,4-DMP and its analogue, 3,4-DMPP. Notably, reproductive toxicity studies conducted on 3,4-DMP involved relatively low doses, which may have skewed the findings. The working group expressed concerns that the absence of observed maternal toxicity in these studies could be due to insufficient exposure levels, especially considering the higher doses used in 3,4-DMPP studies, where adverse effects were reported.
This consultation invites stakeholders to comment on the proposed read-across justification between the two substances. The data collected will play a pivotal role in determining the final classification of 3,4-DMP.
How to Participate
Stakeholders, including manufacturers, downstream users, and the scientific community, are encouraged to provide comments on the reproductive toxicity data and other scientific evidence relevant to the classification of 3,4-DMP. The consultation is accessible through the ECHA’s website and closes at 23:59 Helsinki time on 25 September 2024.
Conclusion
The outcome of this consultation could have far-reaching implications for industries utilising 3,4-DMP. By participating, stakeholders can help shape the regulatory landscape, ensuring that safety measures are adequately aligned with the latest scientific data.
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