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EC number: 226-241-3 | CAS number: 5332-73-0
0 h (no daphnids)
48 h (no daphnids)
48 h (stocked with daphnids)
(% of nominal)
Cumulative immobilisation (n)
*: neutralised sample
pH values after
*: neutralised sample
The study was performed in compliance with its quality criteria: immobilisation in the control did not exceed 10% at the end of the test; test daphnids in the control were not trapped at the surface of the water; concentration of dissolved oxygen in the test vessels remained above 2 mg/L at the end of the test and pH did not vary by more than 1 unit; the concentrations of the test substance have been maintained to within 80% of the initial concentration throughout the duration of the test.
The acute toxicity of the source substance for read across 3-isopropoxypropylamine to the water flea, Daphnia magna, was investigated in a 48-hour static test according to the EEC-Guideline 79/831/EEC method C.2 (Arkema, 1999). Based on nominal concentrations, the 48-hour EC50 was estimated to be 65 mg/L. It should be noted that this value should be considered as a worst case value, as the concentration dependent pH increase caused by the test substance may have affected the results of the study (the pH was > 9 in the two highest test concentrations (75 and 120 mg/L), which is outside of the recommended range in the OECD 202 guideline).
The study on 3-methoxypropylamine from Arkema (1991) received a reliability score of 3 and is considered as a study to be disregarded for endpoint coverage and hazard assessment purposes. This study was performed in accordance with the standard ISO 6341 (1989). The registrant acknowledges that this is an acceptable alternative to the OECD TG 202. However, the study should be disregarded due to two major limitations which significantly compromised the reliability of the study with regards to both ECHA’s guidance on information requirements and chemical safety assessment, and the OECD TG 202 (2004):
* pH adjustment: The pH was not monitored during the study and no pH adjustment was made because this was not requested in ISO standard 6341 (1989). 3-methoxypropylamine is a base. Therefore, one can expect that the pH of the medium was increased by 3-methoxypropylamine and this may have unduly weakened the daphnids. According to OECD TG 202 which is the most widely accepted method and also according to both actualised ISO 6341 (2012) and ECHA’s guidance documents, pH adjustment is necessary in case pH falls below 6 or increases above 9 and toxicity is observed. The experiment was not repeated with pH adjustment. Therefore, it is not possible to distinguish between a potential pH effect and a direct intrinsic toxic effect of the test substance (if any).
*Oxygen level: The oxygen level in the highest treatment after 48 hours was 2.2 mg/L. This was acceptable to the ISO 6341 (1989) validity criterion (> 2 mg/L), but it is not acceptable with regard to the OECD TG 202 validity criterion (> 3 mg/L). The criterion is higher in the guideline because it has been shown that the 2 mg/L criterion was not protective enough against adverse effects related to hypoxia (i.e., adverse effects not due to the substance). It should be noted that O2 generally does not fall below 7 mg/L in this kind of studies.
In addition, there were some other disadvantages of the study that further compromised its reliability:
* No analytical monitoring was performed.
* Lots of documentation is missing for a reliable study assessment (e.g., sample purity not mentioned, no information on statistical analysis).
* The study was not performed under GLP conditions.
For the reasons mentioned above, the registrant concludes that the study of Arkema (1991) is not reliable as the issues above may have impacted the health status of the daphnids and may consequently have overestimated the toxic effects of 3-methoxypropylamine in a way that is not possible to interpret the results of the study in a satisfactory manner. This study should therefore be disregarded and not considered for the derivation of the PNEC nor for classification.
Because the study with 3-methoxypropylamine was disregarded, data on the related substances 2-ethoxyethanamine and isopropoxypropylamine were added to the dossier. The study with 2-ethoxyethanamine yielded a 48-h EC50 value for Daphnia magna of > 100 mg/L, both in test solutions in which pH was adjusted to levels within the recommended range and in test solutions in which pH was not adjusted. However, the results demonstrated that the observed mortality at 100 mg/L in non-adjusted medium was due to the pH increase caused by the test item, as no mortality at all was observed at 100 mg/L in pH-adjusted medium.
In the study with isopropoxypropylamine, a 48-h EC50 of 65 mg/L was obtained for Daphnia magna in test solutions in which pH was not adjusted. No testing was performed in pH-adjusted medium. Since the pH was > 9 in the test solutions with nominal concentrations of 75 and 100 mg/L, the results may have been affected by the increased pH as well. As explained in the read across justification document, the source substance for read across was considered to be isopropoxypropylamine, as a worst case, to cover for the potential existence of direct intrinsic toxic effects of the test substance, which could not entirely be excluded based on the results of the available aquatic toxicity tests. The read across justification document is attached to IUCLID Section 13.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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