Registration Dossier
Registration Dossier
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EC number: 221-359-1 | CAS number: 3077-12-1
Endpoint summary
Administrative data
Description of key information
Additional information
No data is available for the aquatic toxicity of the target substance N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1). Therefore, read-across was performed to the structurally and chemically closely related source substance2-[(2-hydroxyethyl)(4-methylphenyl)amino]ethan-1-ol(EC 911-490-9) in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5 in order to meet the standard information requirements laid down in Annex VIII of the REACh Regulation.
The source substance is a multi-constituent whose main constituent is the target substance itself (2,2’-[4-methylphenyl)imino] diethanol, CAS 3077-12-1) and also contains a second component named (2-{[(2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino)ethanol, CAS 878391-30-1). The second constituent only differs in the composition of one side chain, which additionally contains two C-atoms and an ether group. Based on the high degree of structural and chemical similarity and the fact that the source substance predominantly consists of the target molecule, the target substance is expected to exhibit a similar ecotoxicological profile as the selected source substance. The structural differences of the second constituent of the source substance are not expected to significantly affect the overall aquatic hazard profile. Therefore, the source substance is considered a suitable representative for the prediction of the aquatic toxicity of the target substance by extrapolation from source data, in accordance with Annex XI, item 1.5, of Regulation (EC) No 1907/2006. A detailed read-across approach justification is provided in IUCLID section 13.
By means of the read-across approach, GLP guideline studies are available for the short-term aquatic toxicity to all three trophic levels (fish, aquatic invertebrates and algae) as well as for the long-term aquatic toxicity to aquatic algae. Aquatic invertebrates were the most sensitive trophic level for short-term aquatic toxicity with an EC50 (48 h) of 48 mg/L (nominal, OECD 202) while no effects up to 100 mg/L were recorded to fish (OECD 203) and aquatic algae (short-term and long-term toxicity, OECD 201). The chemical analysis of the test item concentrations in the test vessels confirmed the stability of test item concentrations throughout the duration of the aquatic pelagic toxicity tests.
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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