Registration Dossier
Registration Dossier
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EC number: 204-429-6 | CAS number: 120-83-2
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
Description of key information
A study waiver argument is proposed relating to a granulometry study since 2,4-dichlorophenol is manipulated in the molten form.
Additional information
The particle size distribution would be needed to determine which route of administration would be most appropriate for toxicity studies. The particle size fractions are used to assess possible health effects resulting from inhalation of airborne particles in the workplace.
However in the case of 2,4-Dichlorophenol, this substance is manipulated in the molten form (at temperatures > 45 degrees C) for ease of transporting, transferring, storage and charging.
Annex VII of Regulation (EC) No 1907/2006 (subsection 7.14) states that a granulometry study does not need to be conducted if the substance is marketed or used in a non-solid or granular form.
This statement is reiterated in the ECHA guidance document - "Guidance on information requirements and chemical safety assessment, Chapter R .7a : Endpoint specific guidance" - subsection R.7.1.14.1.
Therefore although 2,4 -dichlorophenol is a solid at room temperature (see section 4.1 -Appearance/physical state/colour) it is manipulated in the molten form. Therefore, it is concluded that it is not necessary, relevant or justified to conduct a granulometry study.
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