Fatty acids, C18-unsatd., reaction products with diethylenetriamine, acetates

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Persistence Assessment

 

P criteria:

– the half-life in marine water is higher than 60 days, or

– the half-life in fresh- or estuarine water is higher than 40 days, or

– the half-life in marine sediment is higher than 180 days, or

– the half-life in fresh- or estuarine water sediment is higher than 120 days, or

– the half-life in soil is higher than 120 days

No experimental half-life data is available on the substance to compare against the persistence criteria, as a hydrolysis (abiotic degradation) study has not been conducted due to the following:

- The test item is a complex reaction mixture. The test is not appropriate for complex reaction mixtures.

- Some of the test item components were estimated to be essentially insoluble in water. The method guidelines state that extremely water-insoluble substances may not be suitable for hydrolysis testing.

However, some hydrolysis of the substance is anticipated to occur, which would be likely to result in the formation of fatty acids and diethylenetriamine, which are considered to be generally readily biodegradable. Acetic acid, if reformed from the acetate salts, is also readily biodegradable.

To further assess the persistence of the substance, its biodegradability is taken into account.

Based on the results obtained from the OECD 306 studies, the substance cannot be considered to be readily biodegradable in the marine environment under the terms and conditions of OECD Guideline No 306, as 60% degradation was not obtained within 28 days.

However, as 35 - 45% degradation after 28 days was obtained, it can be considered that Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts does have some potential to biodegrade in the marine environment.

The results of a marine BODIS study support this. The test was run using three different concentration (addition) rates. After 28 days 42 - 82% degradation was obtained. The test was extended for an additional 14 days to establish whether degradation was continuous after the test period. After 42 days 56 -95% degradation was obtained.

These results support the conclusion that the substance can be considered to have inherent biodegradabilty potential and is expected to ultimately biodegrade in the environment.

Based on this information, it is assessed that the persistence (P) criteria is not met for Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts.

Bioaccumulation Assessment

 

B criterion: BCF > 2000.

No experimental bioaccumulation data is available on the substance and therefore no experimental bioconcentration factor (BCF) is available to assess whether the substance meets the Bioaccumulation criteria (BCF higher than 2000).

The substance has a low n-octanol/water parition coefficient of log₁₀Pow 2.29. The substance is therefore not considered to have the potential to bioaccumulate in organisms and therefore not to meet the screening criteria for B or vB (log Kow >4.5).

To further assess the bioaccumulation potential of the substances individual components, estimates for BCF were run using EPI Suite program Bcfwin (v2.17).

The predictions were run on the individual components in their acetate salt form. The Bcfwin program uses estimated log Kow values generated in the program in the assessment of the bioconcentration factor (BCF). The estimated log Kow values generated from the program for each component were higher than the experimental log Kow of the substance (2.29).

Therefore, the resulting BCF estimations can be considered to represent the worst case.

The maximum, estimated log BCF for all components was 1.85 (BCF 70.79), which indicates that the substance and individual components have a low potential for bioaccumulation.

Therefore, the resulting BCF estimations can be considered to represent the worst case.

The maximum, estimated log BCF for all components was 1.85 (BCF 70.79), which indicates that the substance and individual components have a low potential for bioaccumulation.

Based on this information, it is assessed that the bioaccumulation (B) criteira is not met for Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts.

 

Toxicity Assessment

 

T critera:

– the long-term no-observed effect concentration (NOEC) for marine or freshwater organisms is

less than 0.01 mg/l, or

– the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2) or toxic

for reproduction (category 1, 2, or 3), or

– there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

 

The most sensitive species in marine testing was found to be algae, which gave a geometric mean NOEC result (based on growth rate) of 0.052 mg/L (based on the results of three studies). The worst case NOEC (based on growth rate) from these studies was 0.02 mg/l. Although these were short-term algal tests, they can be viewed as providing both acute and chronic endpoints, based on the short life cycle of Skeletonema costatum. Therefore, if assessed as a chronic endpoint the 'mean' and worst case NOEC results are greater than 0.01 mg/l.

 

Along-term toxicity to aquatic invertebrates study is also available as a 7 dayCeriodaphnia dubio reproduction test was conducted. The 7-day reproductive NOEC and LOEC value were determined to be 0.6 and 1.0 mg/l, respectively. The 7-day survival NOEC and LOEC values were also determined to be 0.6 and 1.0 mg/l, respectively.

Based on this algal data and Ceriodaphnia dubia data, which gave NOEC results of greater than 0.01 mg/l, it is assessed that the criteria for toxicity is not met.

 

The substance is not currently classified as carcinogenic, mutagenic (category 1 or 2) or toxic for reproduction (category 1, 2 and 3) or classified as STOT RE (category 1 or 2) and there is no other evidence of chronic toxicity based on the available study data.

 

Based on the study data available it is assessed that none of the criteria for toxicity (T) are met forFatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts.

 

Summary and overall Conclusions on PBT or vPvB Properties

Based on all data currently available, it is considered that Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts does not meet the criteria for persistence (P), bioaccumulation (B) or toxicity (T), and is therefore not classed as a PBT or vPvB substance.

This outcome is in line with the starting material and read-across substance, Fatty acids, C18 unsaturated, reaction products with diethylenetriamine (Tall oil diethylenetriamine imidazoline), which was also evaluated not to be a PBT or vPvB substance. The neutralization of this substance to form the Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts, is not anticipated to alter the base PBT properties and therefore the assessment that the acetate salts are not a PBT is considered to be valid.