Registration Dossier
Registration Dossier
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EC number: 240-032-4 | CAS number: 15894-70-9
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No reliable long-term toxicity data are available for the toxicity of HMBDA to fish. However, a waiver is applied for this endpoint.
Key value for chemical safety assessment
Additional information
No reliable long-term toxicity data are available for the toxicity of HMBDA to fish. However, a waiver is applied for this endpoint.
Under Column 2 of the Annex IX of Regulation (EC) No 1907/2006 the specific rules for adaptation from Column 1 are that the long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on fish. It is proposed that testing is waived as exposure potential is minimal as substance is an intermediate product and manufactured and utilized only at one location in the EU and handled under strictly controlled conditions. The substance’s low hydrophilicity is demonstrated by the very low octanol-water partition coefficient (Log Kow) of 0.465 at a neutral pH. The low log Kow indicates the substance has a low adsorptive and bioaccumulative potential.
The short-term fish studies reported in this assessment provide evidence of the low toxicity to fish with lethal concentrations (LC50) greater than 13 mg/L. Mean measured concentrations of HMBDA at test initiation and test end ranged from 13-30 percent of nominal demonstrating the very low solubility and that it is impractical to carry out long-term toxicity testing with sparingly soluble substances.
Additionally, aquatic toxicity studies (Harland 1998), provided in Section 6.6 of this dossier, have been conducted on the wastewater effluent from the one facility where the substance is in use. Such effluent toxicity studies were used to determine the maximum effluent release rate where no acute toxicity to fish would occur and no chronic effects to fish would occur at the edge of the mixing zone. Study results indicate that maximum effluent release rates are a magnitude higher than the desirable release rate. Therefore, under such conditions and due to low solubility, minimal exposure to aquatic organisms and no adverse effects to fish are expected. Therefore, no further testing is 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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