Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Toxicity to aquatic fishes:

According to aquatic toxicity module i.eACD/LabsI-Lab 2.0;Algorithm Version: v5.0.0.184 the lethal concentration (LC50) of the test substance (3-aminopropyl)(methyl)amine was predicted to be 740 mg/l on fish species Fathead minnow (Pimephales promelas).

Based on the LC50 calculation the estimated Reliability Index (RI) of test chemical (3-aminopropyl)(methyl)amine predicted to be0.7(As per model substance have moderate and high reliability ifRI > 0.5).Thus reported RII value indicate it has high reliability.And LC50 value indicate that the test substance (3-aminopropyl)(methyl)amine considered as non-toxic, and not harmful to aquatic organisms and thus cannot classified as hazardous as per the CLP criteria.

Toxicity to aquatic invertebrates:

ACD labs predicted median Lethal Concentration (LC50) of daphnia magna using v5.0.0.184. The value is supported by estimated Reliability Index (RI). Based on this, the LC50 value for test item N-Methyl-1,3-propanediamine was predicted to be 120 mg/l for Daphnia magna. On the basis of predicted value it can be concluded that the substance N-Methyl-1,3-propanediamine is considered to be not toxic to aquatic environment as per the criteria mentioned in CLP regulation.

Toxicity to aquatic algae:

Short term toxicity study of N-Methyl-1,3-propanediamine on the growth of marine algae Skeletonema costatum for 72 hrs. Test was performed by static system. The choice of test concentrations was based on a preliminary test with ten-fold dilutions of the test substance (10–10,000 mg/l), in triplicates. Based on the inhibition of growth rate and Area under the growth curves (biomass), the EC50 of chemical 3-Amino-1-methylaminopropane on the Skeletonema costatum was 1065 mg/l. With 95% confidence interval (999-1150). Thus it was concluded that the chemical 3-Amino-1-methyl-aminopropane was nontoxic and can be consider to be not classified as per the CLP classification criteria.

Toxicity to microorganisms:

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the seven closest read across substances, toxicity on microorganisms was predicted for (3-aminopropyl)(methyl)amine (6291-84-5). IGC50 value was estimated to be 355.574 mg/l when (3-aminopropyl) (methyl)amine was exposed to Tetrahymena pyriformis for 48 hours.

Additional information

Summarized result of toxicity of (3-aminopropyl)(methyl)amine (6291-84-5) on the growth and other activity of aquatic invertebrates, algae and cyanobacteria by considering the data for target as well as RA chemical which was selected on the basis of structure similarity are as follows:

Toxicity to aquatic fishes:

Based on the various experimental data and prediction data for the target chemical as well as RA chemical which was selected on the basis of structure similarity study have been reviewed to determine the toxic nature of (3-aminopropyl)(methyl)amine (6291-84-5) on the mortality of fishes. The studies are as mentioned below:

According to the first predicted report for the (3-aminopropyl)(methyl)amine (6291-84-5) from ACD labs aquatic toxicity module i.eACD/LabsI-Lab 2.0; Algorithm Version: v5.0.0.184 the lethal concentration (LC50) of the test substance (3-aminopropyl)(methyl)amine was predicted to be 740 mg/l on fish species Fathead minnow (Pimephales promelas). Based on the LC50 calculation the estimated Reliability Index (RI) of test chemical (3-aminopropyl)(methyl)amine predicted to be0.7(As per model substance have moderate and high reliability ifRI > 0.5).Thus reported RII value indicate it has high reliability. And LC50 value indicate that the test substance (3-aminopropyl)(methyl)amine considered as non-toxic, and not harmful to aquatic organisms and thus cannot classified as hazardous as per the CLP criteria.

 

In the second weight of evidence study for the (3-aminopropyl)(methyl)amine from QSAR toolbox 2017, Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the six closest read across substances, toxicity on Danio rerio (previous name: Brachydanio rerio) predicted for (3-aminopropyl) (methyl)amine. The LC50 value was estimated to be 562.656 mg/l when (3-aminopropyl)(methyl)amine exposed to Danio rerio (previous name: Brachydanio rerio) for 96hrs.

 

Similarly in the third weight of evidence study for the (3-aminopropyl)(methyl)amine from EPISUITE 2017, Based on the prediction done by EPI suite, ECOSAR version 1.1, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the LC 50 value for short term toxicity to aquatic fish was predicted. On the basis of this program the LC 50 value for short term toxicity to fish was predicted to be 17784.615 mg/l for (3-aminopropyl) (methyl) amine in 96 hrs. Based on this value it can be concluded that the (3-aminopropyl)(methyl)amine is considered to be not toxic to aquatic environment and cannot be classified as toxic as per the criteria mentioned in CLP regulation.

 

Similarly in the fourth weight of evidence study for the (3-aminopropyl)(methyl)amine from Danish QSAR, Prediction done using average value of both models i.e Leadscope and SciMatics SciQSAR model and the result were predicted in Battery model. Based on the Danish (Q)SAR Database, the 96hours LC50 was estimated to be 1993.621 mg/l on Pimephales promelas for substance (3-aminopropyl)(methyl)amine with mortality effects. Thus based on this value it can be concluded that the substance (3-aminopropyl)(methyl)amine cannot be classified as toxic as per the criteria of CLP regulation.

Similarly in the fifth weight of evidence study for another RA chemical n-Butylamine (109-95-2) HSDB, ECOTOX database, Evaluation of the effect of n-Butylamine on the growth and mortality rate of Leuciscus idus ssp. Melanotus for 48hrs. After the exposure of 2 days mortality was observed. Based on the rate of mortality of Leuciscus idus ssp. Melanotus due to the exposure of chemical n-Butyl - amine, the LC50 was 171 mg/l (171000 ug/L). Thus based on the LC50 value it was concluded that n-Butylamine was consider as nontoxic and can be consider to be not classified as toxic as per the CLP classification criteria.

Similarly in the sixth weight of evidence study for the RA chemicals 2–methylaminoethanol (109-83-1) IUCLID dataset. Determination of short term toxicity of chemical 2–methylaminoethanol on the growth of fishes. Fishes expose with the chemical for 96hrs, after the exposure mortality was observed. Based on the mortality of test fishes Brachdanio rerio for 96hrs due to the contact with chemical 2-Methylaminoethanol, the LC50 was > 100 mg/l. Thus based on the LC50 value it was concluded that 2–methylaminoethanol was consider as nontoxic and can be consider to be not classified as toxic as per the CLP classification criteria.

 

Thus based on the above data sources for target chemical (3-aminopropyl)(methyl)amine from various experimental studies and predicted studies from QSAR, ACD LAB, EPISUITE, HSDB, it was summarized that the chemical was nontoxic and can be consider to be not classified as toxic as per the CLP classification criteria.

Toxicity to aquatic invertebrates:

Based on the various experimental data and prediction data for the target chemical as well as RA chemical which was selected on the basis of structure similarity study have been reviewed to determine the toxic nature of (3-aminopropyl)(methyl)amine (6291-84-5) on the mobility of daphnia magna. The studies are as mentioned below:

According to the first predicted report for the (3-aminopropyl)(methyl)amine (6291-84-5) from ACD labs predicted median Lethal Concentration (LC50) of daphnia magna using v5.0.0.184. The value is supported by estimated Reliability Index (RI). Based on this, the LC50 value for test item N-Methyl-1,3-propanediamine was predicted to be 120 mg/l for Daphnia magna. On the basis of predicted value it can be concluded that the substance N-Methyl-1,3-propanediamine is considered to be not toxic to aquatic environment as per the criteria mentioned in CLP regulation.

 

In the second weight of evidence study for the (3-aminopropyl)(methyl)amine from QSAR toolbox 2017, Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the seven closest read across substances, toxicity on Daphnia magna predicted for (3-aminopropyl) (methyl)amine.The EC50 value was estimated to be 264.224 mg/l when (3-aminopropyl)(methyl)amine exposed to Daphnia magna for 48 hrs. Thus chemical was consider as nontoxic and can be consider to be not classified as toxic as per the CLP classification criteria.

 

Similarly in the third weight of evidence study for the (3-aminopropyl)(methyl)amine from EPISUITE 2017, Based on the prediction done by EPI suite, ECOSAR version 1.1, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the LC 50 value for short term toxicity to aquatic invertebrates was predicted. On the basis of this program the LC 50 value for short term toxicity to aquatic invertebrates was predicted to be 7898.092 mg/l for N-Methyl-1,3-propanediamine in 48 hrs. Based on this value it can be concluded that the N-Methyl-1,3-propanediamine is considered to be not toxic to aquatic environment and cannot be classified as toxic as per the criteria mentioned in CLP regulation.

 

Fourth study conducted for the RA chemical n-Butylamine (109-73-9) from HSDB and ECOTOX databases 2017 which was selected on the basis of structure similarities. Study for the evaluation of the effect of n-Butylamine on the growth and mobility of daphnia magna for 48hrs. Test was performed in static system. <24 hrs old Strain Lake Langedam daphnia were used in the study. Based on the inhibition of mobility of daphnia magna due to the exposure of chemical n-Butylamine, the EC50 was 100 mg/l. Thus based on the EC50 value it was concluded that n-Butylamine was consider as nontoxic and can be consider to be not classified as toxic as per the CLP classification criteria.

 

Similarly in the fifth weight of evidence study for the another RA chemical Bis((dimethylamino)-methyl)methane (110-95-2) from CEOTOX databases Determination of short term toxicity of chemical Bis((dimethylamino)-methyl)methane on the mobility of daphnia magna. Study was conducted under the static system in which <24 hours old daphnia exposed with chemical for 24hrs. After the exposure effect concentration was observed at which 50% daphnia immobilized. Based on the immobilization of daphnia magna due to the contact with chemical N,N,N',N'-Tetramethyl-1,3-propanediamine for 24 hrs, the EC50 was 107 mg/l with the 95% confidence interval of 90.5 – 125 mg/l.

 

Thus based on the above data sources for target chemical (3-aminopropyl)(methyl)amine from various experimental studies and predicted studies from QSAR, ACD LAB, EPISUITE, HSDB, it was summarized that the chemical was nontoxic and can be consider to be not classified as toxic as per the CLP classification criteria.

Toxicity to aquatic algae:

Based on the various experimental data and prediction data for the target chemical study have been reviewed to determine the toxic nature of (3-aminopropyl)(methyl)amine (6291-84-5) on the growth rate and biomass of algae. The studies are as mentioned below:

 

In the first key study for the target chemical (3-aminopropyl)(methyl)amine (6291-84-5) International Journal of Greenhouse Gas Control, 2012. Short term toxicity study of N-Methyl-1,3-propanediamine on the growth of marine algae Skeletonema costatum for 72 hrs. Test was performed by static system. The choice of test concentrations was based on a preliminary test with ten-fold dilutions of the test substance (10–10,000 mg/l), in triplicates. Based on the inhibition of growth rate and Area under the growth curves (biomass), the EC50 of chemical 3-Amino-1-methylaminopropane on the Skeletonema costatum was 1065 mg/l. With 95% confidence interval (999-1150). Thus it was concluded that the chemical 3-Amino-1-methyl-aminopropane was nontoxic and can be consider to be not classified as per the CLP classification criteria.

 

Similarly in the second experimental supporting study for (3-aminopropyl)(methyl)amine, from Energy Procedia 2009, Short term toxicity study of N-Methyl-1,3-propanediamine on the growth of marine algae Skeletonema costatum for 72 hrs. Test was performed by static system. The choice of test concentrations was based on a preliminary test with ten-fold dilutions of the test substance (10–10,000 mg/l), performed in triplicates. Based on the inhibition of growth rate and Area under the growth curves (biomass), the EC50 of chemical 3-Amino-1-methylaminopropane on the Skeletonema costatum was 1500 mg/l. Thus it was concluded that the chemical 3-Amino-1-methyl-aminopropane was nontoxic and can be consider to be not classified as per the CLP classification criteria.

 

In the third predicted supporting study for the target chemical (3-aminopropyl)(methyl)amine, from EPISUITE, 2017. Based on the prediction done using the EPI Suite ECOSAR version 1.10, the short term toxicity on green algae was predicted for test substance N-Methyl-1,3- propanediamine. On the basis of effects observed in a static freshwater system, the effect concentration EC50 value for the substance is estimated to be 2129.914 mg/l for green algae for 72 hrs. Based on this value, it can be concluded that the test chemical N-Methyl-1,3-propanediamine can be considered as non-toxic to green algae at environmentally relevant concentrations and can be considered not-classified as per the CLP classification criteria.

 

Thus based on the above data sources for target chemical (3-aminopropyl)(methyl)amine from various experimental studies International Journal of Greenhouse Gas Control, 2012, Energy Procedia 2009, and predicted data, it was summarized that the chemical was nontoxic and can be consider to be not classified as toxic as per the CLP classification criteria.

Toxicity to microorganisms:

Based on the various experimental data and prediction data for the target chemical as well as RA chemical which was selected on the basis of structure similarity study have been reviewed to determine the toxic nature of (3-aminopropyl)(methyl)amine (6291-84-5) on the growth of microorganisms. The studies are as mentioned below:

 

In the first predicted report for the target chemical (3-aminopropyl)(methyl)amine (6291-84-5) QSAR 2017, Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the seven closest read across substances, toxicity on microorganisms was predicted for (3-aminopropyl)(methyl)amine (6291-84-5). IGC50 value was estimated to be 355.574 mg/l when (3-aminopropyl) (methyl)amine was exposed to Tetrahymena pyriformis for 48 hours.

 

Similarly in the second weight of evidence study for RA chemical 2-Aminoethanol (141-43-5) HSDB, 2017 study was conducted on the bacteria. Short term toxicity study of chemical 2-Aminoethanol by the exposure with microorganisms for observation of inhibition of NH3-Oxidation. Bacteria exposed for 2hrs with the chemical. After 2hrs inhibition of NH3-Oxidation was observed at the concentration of 12,200 mg/l. Based on the inhibition of NH3- Oxidation of Pseudomonas putida (bacteria) due to the exposure of chemical 2-Aminoethanol, the EC50 was 12,200 mg/l.

 

Similarly in the third weight of evidence study for the another RA chemical 2–methylamino-ethanol (109-83-1) iuclid dataset 2000, Short term toxicity of 2–methylamino- ethanol was studied on the growth of bacteria Pseudomonas putida for 17hrs. Pseudomonas putida exposed for 17hrs and no effect was observed after incubation with chemical. As there is no growth inhibition of bacterial cell due to the chemical 2–methylaminoethanol, the EC0 was determined to be 11500 mg/l. Thus based on the EC0 value it was concluded that 2-methylaminoethanol was consider as nontoxic.

Thus based on the above data sources for target chemical (3-aminopropyl)(methyl)amine from various experimental studies and predicted studies for determination of the toxic effect of chemical on the fishes, invertebrates and algae, it was summarized that the chemical was nontoxic to both invertebrates and algae and can be consider to be not classified as toxic as per the CLP classification criteria.