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PBT assessment

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PBT assessment: overall result

Reference
Name:
Reaction mass of perfluoro(dimethyl - N - Butylamine) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N - propylamine) and 2,2,3,3,5,5,6,6, octafluoro-4-(trifluoromethyl)morpholine and perfluoro-N-pentane
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Reaction mass of perfluoro(dimethyl - N - Butylamine) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N - propylamine) and 2,2,3,3,5,5,6,6, octafluoro-4-(trifluoromethyl)morpholine and perfluoro-N-pentane
Reference substance:
Reaction mass of perfluoro(dimethyl - N - Butylamine) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N - propylamine) and 2,2,3,3,5,5,6,6, octafluoro-4-(trifluoromethyl)morpholine and perfluoro-N-pentane
Reference substance:
Reaction mass of perfluoro(dimethyl - N - Butylamine) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N - propylamine) and 2,2,3,3,5,5,6,6, octafluoro-4-(trifluoromethyl)morpholine and perfluoro-N-pentane
Reference substance:
Reaction mass of perfluoro(dimethyl - N - Butylamine) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N - propylamine) and 2,2,3,3,5,5,6,6, octafluoro-4-(trifluoromethyl)morpholine and perfluoro-N-pentane
Reference substance:
Reaction mass of perfluoro(dimethyl - N - Butylamine) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N - propylamine) and 2,2,3,3,5,5,6,6, octafluoro-4-(trifluoromethyl)morpholine and perfluoro-N-pentane
Reference substance:
Reaction mass of perfluoro(dimethyl - N - Butylamine) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N - propylamine) and 2,2,3,3,5,5,6,6, octafluoro-4-(trifluoromethyl)morpholine and perfluoro-N-pentane
Reference substance:
Reaction mass of perfluoro(dimethyl - N - Butylamine) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N - propylamine) and 2,2,3,3,5,5,6,6, octafluoro-4-(trifluoromethyl)morpholine and perfluoro-N-pentane
Reference substance:
Reaction mass of perfluoro(dimethyl - N - Butylamine) and perfluoro (methyl - di - N - propylamine) and perfluoro (dimethyl - N - propylamine) and 2,2,3,3,5,5,6,6, octafluoro-4-(trifluoromethyl)morpholine and perfluoro-N-pentane
PBT status:
the substance is not PBT / vPvB
Justification:

MTDID 22327 is a UVCB substance. Its PBT properties were assessed in three fractions. The predominant fraction is 2,2,3,3,5,5,6,6-octafluoro-4-(trifluoromethyl)morpholine. The balance consists of a minor perfluorohexane fraction and a mixed low-molecular weight perfluorinated tertiary amines fraction. All fractions of are contained within the category definition of the Perfluorinated Organic Chemicals, C5-C18, and have broadly similar physical/chemical, fate and toxicological properties. MTDID 22327 fractions are not biodegradable and are 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 the fractions of MTDID 22327 are 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 22327 fractions and 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 predominant 2,2,3,3,5,5,6,6-octafluoro-4-(trifluoromethyl)morpholine fraction has a log Kow of 4.3 and therefore meets the screening level criterion for "not B." For other fractions, including the predominant fraction, 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 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. The calculated log Koa values indicates that fractions of MTDID 22327 could not bioaccumulate in air-breathing animals. Collectively, data from the category mammalian pharmacokinetic studies, the mammalian toxicity studies, and the calculated Koa indicate that MTDID 22327 as a whole will not bioaccumulate in air-breathing organisms. MTDID 22327 is not expected to bioaccumulate in aquatic, sediment or soil organisms. MTDID 22327 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 fractions of MTDID 22327, 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 22327, no toxicity was observed. No fractions of MTDID 22327 meet the REACH “T” criteria for aquatic or mammalian toxicity. This information can be used to conclude that none of the fractions of MTDID 22327 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.

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