Reaction mass of 1,1,2,2,3,3,3-heptafluoro-N-(heptafluoropropyl)-N-(pentafluoroethyl)propan-1-amine and 1,1,2,2,3,3,3-heptafluoro-N-(heptafluoropropyl)-N-(trifluoromethyl)propan-1-amine and 1,1,2,2,3,3,3-heptafluoro-N,N-bis(heptafluoropropyl)propan-1-amine

PBT assessment

PBT assessment: overall result

Reference

Name:

reaction mass of perfluoro (methyl - di - N - propylamine) and mono (perfluoro ethyl), di (perfluoro-n-propyl) amine and tri (perfluoro-n-propyl) amine and perfluoro N-methyl N-isopropyl n-propylamine and perfluoro N-methyl, N-isopropyl butamine

Type of composition:

legal entity composition of the substance

State / form:

liquid

Reference substance:

reaction mass of perfluoro (methyl - di - N - propylamine) and mono (perfluoro ethyl), di (perfluoro-n-propyl) amine and tri (perfluoro-n-propyl) amine and perfluoro N-methyl N-isopropyl n-propylamine and perfluoro N-methyl, N-isopropyl butamine

Reference substance:

reaction mass of perfluoro (methyl - di - N - propylamine) and mono (perfluoro ethyl), di (perfluoro-n-propyl) amine and tri (perfluoro-n-propyl) amine and perfluoro N-methyl N-isopropyl n-propylamine and perfluoro N-methyl, N-isopropyl butamine

Reference substance:

reaction mass of perfluoro (methyl - di - N - propylamine) and mono (perfluoro ethyl), di (perfluoro-n-propyl) amine and tri (perfluoro-n-propyl) amine and perfluoro N-methyl N-isopropyl n-propylamine and perfluoro N-methyl, N-isopropyl butamine

PBT status:

the substance is not PBT / vPvB

Justification:

MTDID 50908 is a multi-constituent substance. It consists of mixed low-molecular weight perfluorinated tertiary amines, with one perfluorinated alkylmorpholine and one perfluorinated alkylpiperidine among the tertiary amine impurities. All constituents and impurites are contained within the category definition of the Perfluorinated Organic Chemicals, C5-C18, and have broadly similar physical/chemical, fate and toxicological properties.

MTDID 50908 is not biodegradable and is resistant to all forms of chemical degradation in the environment. The sole known mechanism of removal from the environment is direct phototransformation in the upper atmosphere with a lifetime of 1600 - 4000 years. An evaluation of its

fate in water or soil concludes that MTDID 50908 is rapidly removed by volatilization and will not partition into water or soil from the atmosphere. Therefore this substance is non-persistent in the aquatic and terrestrial environments. It is very persistent only in the atmosphere and is subject to long-range transport. Due to mixing in the atmosphere and lack of partitioning out of the atmosphere, concentrations in the biosphere will be negligible. Widespread exposure will not occur.

Based on the expected partitioning behavior of MTDID 50908 and on the lack of evidence for uptake or metabolism in mammals by any members of this category, additional laboratory studies on the biodegradation and bioaccumulation in the water, sediment and soil compartments are not relevant for the evaluation of PBT properties of this substance. The constituents and impurities in MTDID 50908 have log Kow values > 4.3 and therefore do not meet the screening level criterion for "not B." However, the “B” criterion in aquatic organisms is not met due to lack of exposure. Further direct evidence is supported by lack of uptake or metabolism in mammalian systems. Data from mammalian pharmacokinetic studies indicate that category member FC-770 (for which the morpholine impurity of MTDID 50908 is the predominant constituent) is not taken up at all into systemic circulation nor is it metabolized. Data from repeated dose studies in rats also provide direct evidence demonstrating the absence of adverse systemic and reproductive/developmental effects as well as no potential for dermal sensitization. Calculated log Koa values indicates that constituents and impurities comprising MTDID 50908 could not bioaccumulate in air-breathing animals. Collectively, data from the category mammalian pharmacokinetic studies, the mammalian toxicity studies, and the calculated Koa values indicate that MTDID 50908 as a whole will not bioaccumulate in air-breathing organisms. MTDID 50908 is not expected to bioaccumulate in aquatic, sediment or soil organisms. MTDID 50908 does not fulfill the criteria for bioaccumulative (“B”) or very bioaccumulative (“vB”).

Based on available data, members of this category did not induce toxicity in long-term aquatic toxicity studies at the water solubility limit. In addition, members of this category, including all MTDID 50908, are not classified as carcinogenic, mutagenic, or toxic to reproduction or specific target organ toxicity after repeated dosing. In short term aquatic toxicity limit tests conducted of MTDID 50908, no toxicity was observed. No fractions of MTDID 50908 meet the REACH “T” criteria for aquatic or mammalian toxicity. This information can be used to conclude that none of the fractions of MTDID 50908 fulfill the screening criteria for toxic (“T”).

The data show that the properties of the substance do NOT meet the criteria in Annex XIII Section 1, or while not allowing a direct comparison with all the criteria, nevertheless there is no indication that the substance has P and B properties following the result from the screening tests or other information. Substance is NOT PBT or vPvB.