Amidation products of C16-18 (even numbered), C18 unsaturated fatty acids esters with 1,1'-iminodipropan-2-ol

PBT assessment

PBT assessment: overall result

Reference

Name:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Type of composition:

legal entity composition of the substance

State / form:

liquid

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

Reference substance:

Reaction products of 1,1'-iminodipropan-2-ol and tallow acids (myristic, palmitoleic, palmitic, heptadecenoic, heptadecanoic, linolenic, linoleic, oleic, stearic and arichidic)

PBT status:

the substance is not PBT / vPvB

Justification:

The substance does not screen as a “PBT” or “vPvB” substance on the following grounds:

Persistence

Not P and not vP based on: other screening test(s) (e.g. enhanced ready biodegradability, inherent biodegradability test) under valid conditions:The substance demonstrated the following results in aqueous biodegradation testing:

Ready biodegradation - EU C4 (or equivalent) - 50% and 46% biodegradation

Inherent biodegradation - OECD 302C - 77.9% - inherently biodegradable.

It is proposed therefore that the substance does not screen as P and vP.

Bioaccumulation

Not B and not vB based on: BCF ≤ 2,000 L/kg

The EPISuite BCFBAF Program predicted the BCF/BAF values for four representative components of the chemical. The model predicted similar Log KOW values as the measured Log KOW values which increases the reliability of the predicted BCF/BAF values to a moderate to high reliability.

The EPISuite BCFBAF Program predicted Log BCF values of less than 2.7 for all four representative components indicating the substance is non-bioaccumulative with predicted Log BAF values of 1.90 to 2.27.

In a specific OECD 305 dietary study, the BMFss value was calculated as 6.987E-4, the BMFssL value was 8. 789E-4. The substance has an extremely low bioaccumulation potential

Toxicity

EC10 or NOEC ≥ 0.01 mg/L for marine / freshwater organisms (long-term toxicity)

The NOEC for 21-day Daphnia was 33 μg/L and the 21-day EC50 for reproduction was >33 μg/L. For the Chronic fish test, the NOEC for growth rate was determined to be 69 μg/L. Algal studies presented Growth rate Values of NOEC 0.19 mg/l and EC 10 of 0.16 mg/l with Yield Valuea of 0.19 mg/l and EC10 of 0.17 mg/l. 72h-NOEC for both, growth rate and yield inhibition was 0.19 mg/L. All values are above the "T" limit value of >=0.01 mg/l, hence the substance does not screen as Toxic.

and substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008

The substance is not classified as a CMR on the basis of the study results obtained.

and no other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008

The substance is not classified as a STOT RE 1 or 2 on the basis of the study results obtained.