Registration Dossier
Registration Dossier
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EC number: 300-496-1 | CAS number: 93940-97-7
Endpoint summary
Administrative data
Description of key information
Additional information
Acute toxicity to fish
The short-term toxicity of modified Isophoronediamine (MIPDA, CAS 93940 -97 -7) to fish was assessed under semi-static conditions in an OECD 203 study using Danio rerio as test organism (BASF, 2020, Report no. 17F0241/13E077).
Based on the mortality of the fish the following effect value was determined: 96-h LC50 > 120 mg/L (based on nominal concentrations, verified by analytical measurement). The pH of the test solutions was not adjusted and all validity criteria according to the OECD guideline were fulfilled.
With high probability the substance is concluded to be acutely not harmful to fish.
Long-term toxicity to fish
According to REACH Annex XI, chapter 3 (SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING), testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report. For MIPDA there is a risk assessment available and submitted with the registration dossier, which includes all life cycle steps of the substance. This risk assessment in chapters 9 and 10 of this CSR demonstrates, taking into account the appropriate safety factors, the safe use of the substance throughout its entire life cycle.For none of the protection goals, the use of the substance creates an unacceptable risk. The resulting RCR determined for all compartments demonstrate no significant exposure in all scenarios of the manufacture and all identified uses as referred to in Annex VI section 3.5.
Additionally, fish were proven to be the least sensitive organisms in acute toxicity tests on all three trophic levels with LC50 values exceeding 120 mg/L. The most sensitive organisms tested were daphnids (EC50 (48h) = 51.9 mg/L, analytically verified) for which valid chronic data are already available (21-d NOEC = 3.5 mg/L, based on nominal concentrations, verified by analytical measurement).
Therefore, it is concluded that MIPDA does not pose a long-term risk to fish.
Acute toxicity to invertebrates
The acute toxicity of modified Isophoronediamine (MIPDA, CAS 93940 -97 -7) to aquatic invertebrates (Daphnia magna) was investigated in a 48 -hour static GLP-test according ot OECD 202 (BASF SE 2005, report no. 50EO405/053125). The 48 -h EC50 was determined to be 51.9 mg/L based on nominal concentrations, which were analytically verified. The pH of the test solutions was not adjusted. The test is valid according to OECD criteria.
Therefore, the substance is concluded to be acutely harmful to aquatic invertebrates.
Long-term toxicity to fish / aquatic invertebrates
The long-term toxicity to aquatic invertebrates was assessed under semi-static conditions in an OECD 211 study using Daphnia magna as test organism (BASF, 2020, Report no. 51E0241/13E078).
Based on the reproduction the following effect value was determined: 21-d NOEC = 3.5 mg/L (based on nominal concentrations, verified by analytical measurement).
The pH of the test solutions was not adjusted and all validity criteria according to the OECD guideline were fullfilled.
With high probability the substance is concluded to be chronically not harmful to aquatic invertebrates.
Toxicity to algae and cyanobacteria
The effects of modified Isophoronediamine (MIPDA, CAS 93940 -97 -7) on fresh water algae have been assessed using data from a growth inhibition test according to OECD 201 with the algal species Desmodesmus subspicatus (BASF SE 2013, report no. 60E0241/13X030). Algae were exposed to the following nominal concentrations for 72 h: 4.6, 10, 22, 46 and 100 mg/l. The initial and final concentrations of MIPDA were maintained within the designated limit of 80% of the nominal concentrations. Therefore, the effect concentrations have been calculated using the nominal concentrations. The validity criteria of the study were fulfilled. The 72h-ErC50 was determined to be > 100 mg/L and the 72h-ErC10 was 37 mg/L.
It is concluded that the substance is with high probability acutely not harmful to algae and cyanobacteria.
Toxicity to aquatic microorganisms
A GLP test according to OECD 209 was performed with modified Isophoronediamine (BASF SE 2005, report no. 08G0405/053154). As inoculum actived sludge from a municipal wastewater plant in Mannheim/Germany was used, the pH of the test solutions was adjusted. The EC20 after 180 min was determined to be 450 mg/L (BASF SE, 2005). The test is valid according to OECD criteria.
It is concluded, the inhibition of the degradation activity of activated sludge is not anticipated when the substance is introduced in appropriately low concentrations.
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