Reaction products of fatty acids, tall oil and fatty acids, C18 unsaturated, trimers and fatty acids, C18 unsaturated, dimers with (9Z)-octadec-9-en-1-amine

Endpoint summary

Additional information

If data for Reaction products of fatty acids, tall oil and fatty acids, C18 unsaturated, trimers and fatty acids, C18 unsaturated, dimers with (9Z)-octadec-9-en-1-amine are compared with data for the individual components certain prominent features become obvious, which can be explained by the structureand which may have an impact on the further consideration of the substance in the environment.

 

The substance is the salt of the components Fatty acids, tall oil (CAS:61790-12-3) monomers, dimer and trimers and oleylamine (CAS: 112-90-3). Once the substance is entering the aquatic environment the substance may dissociate into its main components Fatty acids, tall oil monomers, dimer and trimmers and oleylamine. Based on this assumption it seems to be justified to evaluate both components with regard to their behavior in the environment individually.

 

 

Reaction products of fatty acids, tall oil and fatty acids, C18 unsaturated, trimers and fatty acids, C18 unsaturated, dimers with (9Z)-octadec-9-en-1-amine

 

Short-term toxicity to fish:

One valid acute short term fish study is available. The acute toxicity of the registered substance to fish ( zebrafish) was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1992). A static limit test with a water accommodated fraction was conducted . As no mortality was observed at a loading level of 100 mg/L, the NOEL (no observed effect loading) as well as the LC50 are greater than 100 mg/L.

Long-term toxicity to fish:

Long-term toxicity to fish is waived. In Annex IX of Regulation (EC) No 1907/2006, it is laid down that chronic toxicity tests shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is assessed to be a PBT or vPvB. The hazard assessment reveals neither a need to classify the substance as dangerous to the environment, nor that it is a PBT or vPvB substance, nor that there are any further indications that the substance may be hazardous to the environment. Therefore, and for reasons of animal welfare, a long-term toxicity study in fish is not provided.

Short-term toxicity to aquatic invertebrates:

Studies for short-term toxicity to aquatic invertebrates were not performed since a study for long term toxicity to aquatic invertebrates is available.

Long-term toxicity to aquatic invertebrates:

In a 21-day chronic toxicity study according to OECD 211, Daphnia magna were exposed to Reaction mass of Fatty acids, tall-oil, compds. with oleylamine and Fatty acids, C18-unsatd., trimers, compds. with oleylamine at nominal (loading) concentrations of 0 (control), 0.1, 0.32, 1.0, 3.2, 10 mg/L. Mortality, reproduction and sublethal effects were observed daily. The following overall effect concentrations (mg/L) were obtained based on nominal (loading) concentrations: NOEC/NOELR ≥ 10 mg/L.

                                                                                                 

Toxicity to aquatic algae

In a 72-hour algal growth study, cultures of Desmodesmus subspicatus were exposed to Reaction mass of Fatty acids, tall-oil, compds. with oleylamine and Fatty acids, C18-unsatd., trimers, compds. with oleylamine. the EC10 and EC50 based on growth rate were determined to be: EC10 : 9.73 mg/L; EC50: 26.8 mg/L

Toxicity to microorganisms:

In a valid OECD 209 test the respiratory inhibition to activated sludge of a domestic STP was determined over 3h. The EC10 and EC50 have been determined to be > 1000 mg/L.

Oleylamine:

 

Fish: The EU risk assessment for primary amines refers for oleylamine to fish studies performed according to OECD 201 in Brachydanio rerio in which a LC50 value in a range of 0.1-1 mg/L was determined.

 

Daphnia: In an OECD 202 study with Daphnia magna an EC 50 of 0.01 mg/L after 48h was determined for oleylamine (EU risk assessment for primary amines). Additionally a long term Daphnia magna data performed in an OECD 211 study are available. After 21 d a NOEC of 0.013 mg/L was detected for oleylamine.

 

Algae: The EU risk assessment for primary amines describes several algae studies according to OECD 201 in Scenedesmus subspicata. After 72h the lowest EC50 was determined to be 0.4616 mg/L for coco oleylamine. The NOEC was derived to be 0.15 mg/L (EU risk assessment for primary amines).

 

 

Fatty acids, tall oil (monomers, dimers and trimers):

The HPV consortium for Fatty acids - dimers and trimers, reports several short term studies in fish, daphna and algae performed to OECD guidelines. For all three trophic levels NOELs (no observed effect loading) of > 1000 mg/L were determined. Long term studies, however, are not available.

 

Overall conclusion forFatty acids, tall oil, compd. with oleylamine

Comparing the results of the acute aquatic tests in fish, daphnia and algae of Fatty acids, tall oil, compd. with oleylamine with test results for oleylamine on the one hand and with test results for Fatty acids, tall oil on the other hand it is concluded that the aquatic toxicity of Fatty acids, tall oil, compd. with oleylamine is driven by the toxic potential of the oleylamine, whereas Fatty acids, tall oil are non- toxic.

As a consequence of this conclusion the toxic properties of Fatty acids, tall oil compd. with oleylamine will be linked to the ecotoxic properties of oleylaminein case data for the UVCB Fatty acids, tall oil compd. with oleylamine are not available. As a further consequence toxic properties with regard to the terrestrial compartment are also linked to oleylamine.