Reaction mass of Amines, N-tallow alkyltrimethylenedi-, mono(2-ethylhexanoates), Amines, N-tallow alkyltrimethylenedi-, acetates and n-tallow-1,3-diaminopropane ditallate

Endpoint summary

Description of key information

Summary table of degradation rate constants in various (eco) systems based on the ready biodegradability of alkyl-1,3 -diaminopropanes (including R814M):

 

(Eco)system	Method	Half-life
Surface water (fresh)	TGD default value for readily biodegradable substances	15 days
Surface water (fresh) sediment	Read across from half-life hexadecylamine	17 days
Marine water	TGD default value for readily biodegradabl substances	50 days
Soils	Read across from half-life hexadecylamine	17 days^a
Degradation in sewage treatment plants	Determined in STP simulation test	99.4% removal primarily by biodegradation

^aHalf-life of the fraction dissolved in the water phase is expected to in the order of a few days.

Additional information

Biodegradation screening tests are available for various structurally related alkyl-1,3-diaminopropanes. This includes oleyl- and tallow-1,3-diaminopropane acetate and oleic acid salts. For all ready biodegradability was demonstrated. The 10 day window (for OECD 301D 14 day window) was not evaluated because the test substances are UVCB’s and degrade sequentially by a consortium of microorganisms (Ginkel, 1996). The 10-day time window criterion was developed on the assumption that a test substance is degraded according to a “standard” growth curve in ready biodegradability tests. The time-window should be ignored as a pass fail criterion because of these scientific reasons.

 

Tallow-1,3-propanediamine oleates (CAS no.: 1307863-78-7) did not cause a reduction in the endogenous respiration. The test substance is therefore considered to be non-inhibitory to the inoculum. Tallow-1,3-propanediamine oleates was biodegraded 65% at day 28 in the Closed Bottle test (Ginkel, 2010). Hence this substance is classified as readily biodegradable.

 

Oleyl-1,3-propanediamine oleates (CAS no.: 40027-38-1 or 34140-92-5) is readily biodegradable in an aerobic ready biodegradation test according to OECD TG 301F. The test item was mineralised by 61% in 28 days (Gancet, 2004). Hence this substance is classified as readily biodegradable.

 

Tallow-1,3-propanediamine acetates (CAS no.: 61791-54-6) was tested in the presence of silica gel to mitigate the toxicity to the inoculum. Tallow-1,3-propanediamine acetates was biodegraded 76% at day 28 in the Closed Bottle test (Ginkel, 1990). Hence this substance is classified as readily biodegradable.

 

Oleyl-1,3-diaminopropane (CAS no.: 7173-62-8) was biodegraded 66% at day 28 in the Closed Bottle test and should therefore be classified as readily biodegradable.

 

Based on the available studies on biodegradation, all alkyl-1,3 -diaminopropanes (C10 - C18) including their fatty acid salts, are considered to be readily biodegradable. The 10-days-window criterion does not need to be evaluated as the alkyl 1,3 -diaminopropanes are UVCB substances. . No simulation tests for degradation rates under environmental conditions are available, therefore the default values suggested in the REACH guidance may be used. Because of the observed ready biodegradability there is no requirement for performing a soil biodegradation test (Annex IX. 9.2.1.3). However a soil biodegradation test is performed with the structurally related¹⁴C-hexadecyl amine. The observed half-life of¹⁴C hexadecyl amine of 8.98 days at 20 °C as determined according to an OECD 307 test is used for read-across to the alkyl-1,3-diaminopropanes as both the primary alkyl amines and diamines are structurally related, readily biodegradable and have a similar sorption to soil. This means that for the risk assessment a half-life for soil and sediment of 17 d at 12°C can be considered realistic for alkyl-1,3-diaminopropanes. This half-life is also used for R814M because under environmental conditions a large extent of the salt is considered to be dissociated to tallow-1,3 –diaminopropane and acetate, 2-ethylhexanoate and Tall oil fatty acid. Available ecotoxicity test data confirm this high degree of dissociation based in similar aquatic ecotoxicity observed for R814M and tallow or oleyl-1,3 -diamino propane.

 

A waste water treatment simulation test was performed with amines, N-C16-18-alkyl (even-numbered) propane-1,3-diamine (133779-11-0). 99.4% removal was observed using specific chemical analyses (LCMS/MS) of the effluent during day 56 to 60 (n=5). In addition, sorption to sludge was measured and this accounted for 4.1% of the total removal which means that 95.3% was removed by biodegradation.

Summary table of degradation rate constants in various (eco) systems based on the ready biodegradability of alkyl-1,3 -diaminopropanes (including R814M):

 

(Eco)system	Method	Half-life
Surface water (fresh)	TGD default value for readily biodegradable substances	15 days
Surface water (fresh) sediment	Read across from half-life hexadecylamine	17 days
Marine water	TGD default value for readily biodegradabl substances	50 days
Soils	Read across from half-life hexadecylamine	17 days^a
Degradation in sewage treatment plants	Determined in STP simulation test	99.4% removal primarily by biodegradation

^aHalf-life of the fraction dissolved in the water phase is expected to in the order of a few days.