Registration Dossier
Registration Dossier
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A mixture of isomers of: 1,1'-[(3,5(or 2,4 or 4,6 or 2,6)-dihydroxy-o(or m or p)-phenylene)bis(azo-meta-phenyleneazo{1-[3-(dimethylamino)propyl]-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl})]dipyridinium-dichloride-dihydrochloride; 1-(1-[3-(dimethylamino)propyl]-5-{3-[x-(4-{1-[3-(dimethylamino)propyl]-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-5-pyridinio-3-pyridylazo}phenylazo)-2,4(or 2,6 or 3,5 or 4,6)-dihydroxyphenylazo]phenylazo}-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-3-pyridyl)pyridinium-dichloride-dihydrochloride (where x is variable)
EC number: 404-540-1 | CAS number: 159405-95-5 BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
Toxicity to terrestrial plants
Administrative data
Link to relevant study record(s)
Description of key information
Waiving.
Key value for chemical safety assessment
Additional information
Based on Annex IX of the REACH Regulation (EC 1907/2006), studies on toxicity to terrestrial organisms need not to be conducted if direct or indirect exposure of the substance to the soil compartmen is not to be expected. This deems to be the case for the following reasons:
(1) the substance is highly water soluble, has a low Kow and Koc, and thus has a very low potential to adsorb to soil particles.
(2) based on ECHA's "Guidance on information requirements and chemical safety assessment - Chapter R.7c: Endpoint specific guidance", if there is no exposure of the soil, or the exposure is so low that no refinement of the PEClocal or PECregional, or PNECsoil organisms is required, then this test may not be necessary.
(3) according to ECHA guidenace documents it generally can be assumed that soil exposure will occur unless it can be shown that there is no sludge application to land from exposed STPs and that aerial deposition are negligible and the relevance of other exposure pathways such as irrigation and/or contact with contaminated waste is unlikely. To this end, sludge application to land is not of relevance, as the substance has no adsorption capacity to wastewater sludge. Aerial deposition is considered negligible due to the use of the substance as a dye in aqueous solution. For the same reasons other exposure pathways such as irrigation and/or contact with contaminated waste are unlikely to become significant.
(4) aside from a certain body weight loss (compared to the control group) observed at test item concentrations > 125 mg/kg, the earthworm acute toxicity study did not reveal any toxic effects up to a concentration of 1000 mg/kg dw soil.
(5) the absence of any adverse effects during the activated sludge respiration inhibition study up to a concentration of 100 mg/l.
Based on these evidences, no further terrestrial toxicity studies seem to be needed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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