Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short term toxicity to fish:

1 Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C12-18(even numbered) acyl) derivs., hydroxides, inner salts was used as a test material to evaluate its toxicity to fish Zebrafish (Brachydanio rerio) , the fish were exposed to nominal concentrations of 0 , 5.66 or 8.0 mg/l under static condition for 96 h The test substance purity was reported 30% active ingredient. All fish exposed to 8.0 mg/L died within the first 24 hours of exposure.

 

The medial lethal concentration (EC50) for test material on Zebrafish after 96 h was observed to be 2.0 mg/l.

 

Though , according to the above concentration the test material can be considered as toxic to aquatic environment and can be classified as acute aquatic – 2 , but the substance is readily biodegradable in aquatic environment. Hence, the test material can not be classified as per CLP classification.

Long term toxicity to fish:

Long term toxicity to fish for 28 days was evaluated for the test material 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts on Oncorhynchus mykiss as per OECD 204 Long Term Fish Test.

The no effect concentration (NOEC) and low effect concentration (LOEC) after 28 days was observed to be 0.16 mg/l and 0.5 mg/l respectively. Hence on, the basis of above no effect concentation it can be considered that 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts can be classified as aquatic chronic 3 for long term toxicity to fish.

Short term toxicity to aquatic invertebrate:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts was used as a test material to evaluate toxicity of aquatic invertebrate in a 48 h short term study as described in OECD guideline 202.

 

The product was administered in a single dose per dose level, dissolved in the water held in the test tubes, which was similar to that used in the breeding period. The daphnia were then transferred to the vessels. The dilution water was aerated to saturation level prior to introduction of the test substance to ensure that the oxygen level did not fall below 60% of the saturation value.

 The Daphnia were monitored one, 24 and 48 hours after the start of treatment. Observations included a determination of the number of immobilized animals, that is to say animals not able to swim within 15 seconds after gentle agitation of the test container.

 The product caused 0% immobilization at the 0.5 mg/l concentration. At concentrations of 1 mg/l and 2 mg/l, 2 and 3 daphnia, respectively, out of a total of 40, were found immobile. The 4 mg/l and 8 mg/l concentrations caused immobilization in 5 and 9 daphnia, respectively, out of a total of 20. All the animals treated at the 16 mg/l concentration were found immobile. 1.7% immobilization was recorded in the Control group.

The effect concentration at which 50% immobilization of daphnia was observed to be 6.40 mg/l.

Though , according to the above concentration the test material can be considered as toxic to aquatic environment and can be classified as aquatic chronic– 2 , but the substance is readily biodegradable in aquatic environment. Hence, the test material can not be classified as per CLP classification.

Long term toxicity to aquatic invertebrate:

Long term toxicity test for aquatic invertebrates was performed for 21days according to OECD 202 Daphnia Reproduction test. The no observed effected concentration (NOEC) and low obderved effect concentration (LOEC) was observed to be 0.9 mg/l and 3.6 mg/l respectively.

Hence on, the basis of above no effect concentation it can be considered that 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts can be classified as aquatic chronic 3 for long term toxicity to daphnia.

Toxicity to aquatic algae and cyanobacteria:

Toxicity of aquatic algae and cyanobacteria was evaluated for test chemical Cocamidopropyl Betaine on marine microalgae Ulva lactuca.

 

Prior to experimentation, thalli were maintained for 3 days in Perspex aquaria containing 5 l of aerated, filtered , seawater (salinity = 33.8) in a temperature-controlled culture room set at 15° (representative of local, summer seawater temperatures) under a irradiance of on a 12:12 h light: dark photoperiod.Approximately 24 h prior to commencing the experiments, discs of 16 mm diameter were cut from the central portion of ca. 30 individual thalli using a plastic cork borer and left to recover from any resulting trauma. From the pooled discs, two or three were randomly selected and transferred to individual glass beakers containing 100 ml of treatment solutions.

 

The nominal concentration selected for the experiment were 0, 5, 10, 15, 20, 25, 30, 35 and 40 mg/l. Data were analysed by either Repeat Measure Analysis of Variance (ANOVA) using SPSS (v.15.0) or by one-way or two-way ANOVA using Minitab (v. 15).The 50% effect on biomass of marine microalgae was observed in the concentration 30 mg/l after 48 h.

Though , according to the above concentration the test material can be considered as toxic to aquatic environment and can be classified as acute aquatic – 3, but the substance is readily biodegradable in aquatic environment. Hence, the test material can not be classified as per CLP classification.

Toxicity to microorganism:

Toxicity of test material Cocamidopropyl Betaine was evaluated for its efficiency in cell multiplication and oxygen consumption inhibition of test organism Pseudomonas putida for 16 hrs. No adverse effect of test material was observed on test organism Pseudomonas putida for its cell multiplication and oxygen consumption inhibition. the reported EC0 was >3000 mg/l

Additional information

Short term toxicity to fish:

The available data for test chemical 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts from peer reviewed handbook , authorative databases are summarized below.

1) 1 Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C12-18(even numbered) acyl) derivs., hydroxides, inner salts was used as a test material to evaluate its toxicity to fish Zebrafish (Brachydanio rerio) , the fish were exposed to nominal concentrations of 0 , 5.66 or 8.0 mg/l under static condition for 96 h The test substance purity was reported 30% active ingredient. All fish exposed to 8.0 mg/L died within the first 24 hours of exposure.

 

The medial lethal concentration (EC50) for test material on Zebrafish after 96 h was observed to be 2.0 mg/l.

 

Though , according to the above concentration the test material can be considered as toxic to aquatic environment and can be classified as acute aquatic – 2 , but the substance is readily biodegradable in aquatic environment. Hence, the test material can not be classified as per CLP classification.

2)Short term test to evaluate toxicity of test material1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts was performed according to OECD Guideline 203.

 

For the main study, two groups were used, each containing 10 animals. Ten Control fish were also included. Animals were placed in 84-liter glass tanks

containing 50 liters of de chlorinated drinking water.

 

The 10 fish exposed to the 8.0 mg/l concentration died during the first 24 hours after treatment. Before death, they showed a decrease in mobility and breathing difficulties. Two of the animals remained on the surface of the aquarium and the others at the bottom. The 5.66 mg/l concentration did not cause the death of any of the treated animals. Only a slight decrease in mobility was noted between 3 and 24 hours after treatment. None of the fish in the Control group died. The medial lethal effect concentration was observed to be 6.73 mg/l after 96 hrs of treatment.

Though , according to the above concentration the test material can be considered as toxic to aquatic environment and can be classified as acute aquatic – 2 , but the substance is readily biodegradable in aquatic environment. Hence, the test material can not be classified as per CLP classification.

3)The test subastance1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner salt (betaine) was evaluated for its short term toxicity effect on Cyprinus carpio.

The nominal test concentrtaions used in the test were 0, 1.0, 1.7, 3.0, 5.0, and 9 mg/L. under semi static conditions for 96 hours. The test substance purity was reportedly 29.6% active ingredient. The median lethal concentration of test material on Cyprinus carpio was observed to be 1.9 mg/l after 96 h.

Though , according to the above concentration the test material can be considered as toxic to aquatic environment and can be classified as acute aquatic – 2 , but the substance is readily biodegradable in aquatic environment. Hence, the test material can not be classified as per CLP classification.

Long term toxicity to fish:

Long term toxicity to fish for 28 days was evaluated for the test material 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts on Oncorhynchus mykiss as per OECD 204 Long Term Fish Test.

The no effect concentration (NOEC) and low effect concentration (LOEC) after 28 days was observed to be 0.16 mg/l and 0.5 mg/l respectively. Hence on, the basis of above no effect concentation it can be considered that 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts can be classified as aquatic chronic 3 for long term toxicity to fish.

Short term toxicity to aquatic invertebrate:

The available data for test chemical 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts from peer reviewed handbook , authorative databases are summarized below.

1) 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts was used as a test material to evaluate toxicity of aquatic invertebrate in a 48 h short term study as described in OECD guideline 202.

 

The product was administered in a single dose per dose level, dissolved in the water held in the test tubes, which was similar to that used in the breeding period. The daphnia were then transferred to the vessels. The dilution water was aerated to saturation level prior to introduction of the test substance to ensure that the oxygen level did not fall below 60% of the saturation value.

 The Daphnia were monitored one, 24 and 48 hours after the start of treatment. Observations included a determination of the number of immobilized animals, that is to say animals not able to swim within 15 seconds after gentle agitation of the test container.

 The product caused 0% immobilization at the 0.5 mg/l concentration. At concentrations of 1 mg/l and 2 mg/l, 2 and 3 daphnia, respectively, out of a total of 40, were found immobile. The 4 mg/l and 8 mg/l concentrations caused immobilization in 5 and 9 daphnia, respectively, out of a total of 20. All the animals treated at the 16 mg/l concentration were found immobile. 1.7% immobilization was recorded in the Control group.

The effect concentration at which 50% immobilization of daphnia was observed to be 6.40 mg/l.

Though , according to the above concentration the test material can be considered as toxic to aquatic environment and can be classified as aquatic chronic– 2 , but the substance is readily biodegradable in aquatic environment. Hence, the test material can not be classified as per CLP classification.

2)Short term toxicity of test material Cocamidopropyl Betaine was evaluated on Daphnia magna for 48h according to OECD guideline 202.The daphnids were exposed to the substance in 50-ml beakers containing 20 ml of test solution with 10 daphnids per beaker.Daphnids were laboratory bred and less than 24 hours old at test initiation. Test levels were 0 (control), 6.25, 12.5, 25, 50 and 100 mg/l. Test levels were run in duplicate The EC50 for the test chemical on aquatic invertebrate after 48 hrs was observed to be 21.5 mg/l.

Though , according to the above concentration the test material can be considered as toxic to aquatic environment and can be classified as aquatic chronic– 2 , but the substance is readily biodegradable in aquatic environment. Hence, the test material can not be classified as per CLP classification.

Long term toxicity to aquatic invertebrate:

Long term toxicity test for aquatic invertebrates was performed for 21days according to OECD 202 Daphnia Reproduction test. The no observed effected concentration (NOEC) and low obderved effect concentration (LOEC) was observed to be 0.9 mg/l and 3.6 mg/l respectively.

Hence on, the basis of above no effect concentation it can be considered that 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts can be classified as aquatic chronic 3 for long term toxicity to daphnia.

Toxicity to aquatic algae and cyanobacteria:

The available data for test chemical 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts from peer reviewed journal, peer reviewed handbook , authorative databases are summarized below.

1) Toxicity of aquatic algae and cyanobacteria was evaluated for test chemical Cocamidopropyl Betaine on marine microalgae Ulva lactuca.

 

Prior to experimentation, thalli were maintained for 3 days in Perspex aquaria containing 5 l of aerated, filtered , seawater (salinity = 33.8) in a temperature-controlled culture room set at 15° (representative of local, summer seawater temperatures) under a irradiance of on a 12:12 h light: dark photoperiod.Approximately 24 h prior to commencing the experiments, discs of 16 mm diameter were cut from the central portion of ca. 30 individual thalli using a plastic cork borer and left to recover from any resulting trauma. From the pooled discs, two or three were randomly selected and transferred to individual glass beakers containing 100 ml of treatment solutions.

 

The nominal concentration selected for the experiment were 0, 5, 10, 15, 20, 25, 30, 35 and 40 mg/l. Data were analysed by either Repeat Measure Analysis of Variance (ANOVA) using SPSS (v.15.0) or by one-way or two-way ANOVA using Minitab (v. 15).The 50% effect on biomass of marine microalgae was observed in the concentration 30 mg/l after 48 h.

Though , according to the above concentration the test material can be considered as toxic to aquatic environment and can be classified as acute aquatic – 3, but the substance is readily biodegradable in aquatic environment. Hence, the test material can not be classified as per CLP classification.

2)The study measured the inhibition of the test substance on the growth of Scenedesmus subspicatus over a 72-hour exposure period was performed according to OECD guideline 201.Four replicate test flasks were run at each treatment level. Tests were run under continuous lighting of 35 – 70 μE/m2*s at a temperature of 23 ± 2 °C. Endpoints were determined for algal growth rate and algal cell density. The EC0, EC10, and EC50 were calculated for rate and cell density.

 

The selected nominal concentrations were 0 (control), 0.32, 1.0, 3.2, 10, 32, and 100 mg/l.The effect concentrations of biomass and growth rate on green algae after 72 h was observed to be 30 mg/l and 48 mg/l respectively.

Though , according to the above concentration the test material can be considered as toxic to aquatic environment and can be classified as acute aquatic – 3, but the substance is readily biodegradable in aquatic environment. Hence, the test material can not be classified as per CLP classification.

3)The experiment assessed the growth inhibition of the test substance on Scenedesmus subspicatus. Test concentrations were 0 (control), 0.01, 0.03, 0.1, 0.3, 1.0, 3.0 and 10 mg product/l. Each experimental group was replicated three times. Test vessels were 300-ml Erlenmeyer flasks holding 100 ml of test solution. At the beginning of the test, flasks were inoculated with 1.0 ml of algal cell inoculum to achieve a concentration in each flask of 1 × 104 cells/ml. Flasks were placed under continuous lighting of 2000 lux and continuously shaken at 120 rpm by means of an orbital shaker. At 24, 48, 72 and 96 hours, a sample from each flask was taken and the density of algal cells in the sample (cells/ml) was measured using an electronic particle counter (Coulter-Counter). Celldensities were converted to growth rates and growth rates were used in the calculation of EC values.

Though , according to the above concentration the test material can be considered as toxic to aquatic environment and can be classified as acute aquatic – 2 , but the substance is readily biodegradable in aquatic environment. Hence, the test material can not be classified as per CLP classification.

4)Toxicity of test material Cocamidopropyl Betaine was evaluated on green algae Selenastrum capricornutum, The effect concentration of test material to inhibit 50% cell growth was observed to be 0.55 mg/l. On the basis of effect concentration the substance can be considered toxic, but on the basis of previous detailed study and the property of readily degradibility of test chemical it can be cocnsidered not classified as per CLP classification.

Toxicity to microorganism:

Various results and antibacterial efficiency have been noticed for the target chemical 1-Propanaminium, 3-amino-N-(carboxymethyl) -N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts as mentioned below.

1) Toxicity of test material Cocamidopropyl Betaine was evaluated for its efficiency in cell multiplication and oxygen consumption inhibition of test organism Pseudomonas putida for 16 hrs. No adverse effect of test material was observed on test organism Pseudomonas putida for its cell multiplication and oxygen consumption inhibition. the reported EC0 was >3000 mg/l.

2)The effect concentration (EC0) of test material Cocamidopropyl Betaine on microorganism Pseudomonas ariginosa after 24 h of testing was observed to be >100 mg/l. No adverse effect on the growth was observed.

3)Toxicity of test material Cocamidopropyl Betaine was evaluated on Staphalococcus epidermis for 48 h . The effect concentration (EC10) for the test chemical after 24 h of exposure to test organism Staphalococcus epidermis was observed to be 2.5 mg/l . 10% of growth inhibition was observed. 

4)Toxicity of test material Cocamidopropyl Betaine on test organism Baillus albicans was observed for 24 h. The effect concentraion (EC10) for the test chemical on Baillus albicans was observed to be 20 mg/l.

5)Toxicity of test material Cocamidopropyl Betain on test organism Aspergillus niger was observed for 24 h. The effect concentraion (EC10) for the test chemical on Aspergillus niger was observed to be 20 mg/l.