Reaction products of fatty acids, C18 (unsaturated) alkyl and epoxidized fatty esters, with amines polyethylenepoly-, tetraethylenepentamine

Endpoint summary

Description of key information

Summary of results:

OECD Number	Study	Result	Classification
OECD 105	Water Solubility	>49.4 w/w of solution	Cat 1 Acute Cat 1 Chronic
OECD 201	Algal growth Inhibition	ERC50 0.027 mg/L NOEC 0.0013 mg/L
OECD 202	Acute Daphnia Inhibition	EC50 0.34 mg/L
OECD 301 F	Ready Biodegradability	0% biodegradation after 28 days

 

Ready Biodegradability

Available Study: OECD Guideline for Testing of Chemicals (1992) No. 301F, “Ready Biodegradability; Manometric Respirometry Test”.

An initial test conducted at a test concentration of 100 mg/L was terminated after 13 days as the toxicity control had attained 0% biodegradation thereby indicating that it would not pass the validation criterion whereby this vessel needs to attain at least 25% biodegradation by Day 14 of the test for the test item to be considered non-inhibitory.

A second test was conducted which also showed that the toxicity control attained 0% biodegradation after 14 and 28 days which confirmed that the test item was demonstrating an inhibitory effect on the sewage treatment micro-organisms used in the test. Therefore, to try to minimize any inhibitory effects of the test item, the definitive test conducted at a reduced test item concentration of 30 mg/L was exposed to sewage treatment microorganisms with mineral medium in sealed culture vessels in diffuse light at temperatures of between approximately 21 and 22 ºC for 28 days.  

The test item attained 0% biodegradation after 28 days and therefore cannot be considered readily biodegradable under the strict terms and conditions of OECD Guideline No. 301F.  

Additionally, the toxicity control attained 0% biodegradation after 14 and 28 days thereby, not passing the validation criterion of attaining at least 25% biodegradation by Day 14 of the test for the test item not to be considered to be demonstrating an inhibitory effect.  Care should therefore be taken in the interpretation of this result. No conclusion on the degradability of the substance can be made.

Daphnia Magna

Available Study: OECD Guideline for Testing of Chemicals (April 2004) No 202, "Daphnia sp., Acute Immobilisation Test".

Following a preliminary range-finding test, 4 replicates of 5 animals were exposed to aqueous solutions of the test item at nominal concentrations of 0.10, 0.18, 0.32, 0.56 and 1.0 mg/L for 48 hours at a temperature of approximately 19 oC to 21 oC under semi-static test conditions.  The number of immobilized Daphnia was recorded after 24 and 48 hours.

Analysis of the freshly prepared test solutions at 0 and 24 hours showed measured test concentrations to range from 89% to 105% of nominal.  Analysis of the corresponding aged test solutions at 24 and 48 hours showed a concentration dependent decline in measured test concentrations in the range of 18% to 76% of nominal indicating that the test item was unstable under the conditions of the test. Given this decline in measured test concentrations it was considered justifiable to base the results on the geometric mean measured test concentrations in order to give a "worst case" analysis of the data.  The geometric mean measured test concentrations were determined to be 0.042, 0.085, 0.14, 0.36 and 0.80 mg/L.

Exposure of Daphnia magna to the test item gave the following results:

Time Point (Hrs)	EC50 (mg/L)	95% confidence Limits (mg/L)	No Observed Effect Concentration (NOEC) (mg/L)	Lowest Observed Effect Concentration (LOEC) (mg/L)
48	0.34	Not determinable	0.14	0.36

 

Given the substance should not be readily hydrolysed in water, and the nominal concentrations in aqueous solution were <1 mg/L, the substance fulfils the criteria for classification as Category 1 Acute Aquatic Toxicity, per CLP, Annex I, Section 4.1, Table 4.1.0.

Green Algae

Available study: OECD Guideline for Testing of Chemicals(2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test".

Following preliminary range-finding tests and an initial experiment, Raphidocelis subcapitata was exposed to aqueous solutions of the test item at nominal concentrations of 0.00625, 0.0125, 0.025, 0.050 and 0.10 mg/L (three replicate flasks per concentration) for 72 hours, under constant illumination and shaking at a temperature of 24 ± 1 °C.  Due to the nature of the test the study was conducted with no media renewal (static). Growth was observed to be reduced by >50% at 0.05mg/L (56%)

 Analysis of the test preparations at 0 hours showed measured test concentrations to range from less than the limit of detection (LOD) of the analytical method employed, determined to be 0.0025 mg/L, to 0.037 mg/L.  A decline in measured test concentrations was observed to less than the LOD in all test preparations at 24 and 48 hours, and from less than the LOD to 0.0074 mg/L at 72 hours.  These results indicate that the test item was unstable under the conditions of the test.

 

 Given this decline in measured test concentrations it was considered justifiable to base the results on the geometric mean measured test concentrations in order to give a "worst case" analysis of the data.  The geometric mean measured test concentrations were determined to be 0.0013, 0.0017, 0.0019, 0.0021 and 0.0045 mg/L. Exposure of Raphidocelis subcapitata to the test item gave the following results based on the geometric mean measured test concentrations:

Response Variable	Endpoint	Measured Concentration	95% Confidence Limits (mg/L)
Growth Rate	ErC10	0.0011	0.00042-0.0014
	ErC50	0.0027	0.0022-0.0040
	NOEC	0.0013	N/A

Given the substance is not readily biodegradable, should not be easily hydrolysed in water, and even taking nominal concentrations a greater than 50% reduction was observed at <0.1mg/L, the substance fulfils the criteria for classification as Category 1 Acute Aquatic Toxicity and Category 1 Chronic Aquatic toxicity per CLP, Annex I, Section 4.1, Table 4.1.0.