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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Persistence assessment:The test substance has been reported asreadily biodegradable based on a Manometric Respiratory test following OECD 301F. According to the GLP study, biodegradation began soon after addition to the test mixtures and after 28 days reached 90.1 ± 6.5% (mean ± 1 SD) based on biological oxygen demand (BOD) and exceeded 60% biodegradation within 5.9 days of test initiation and within the 10-day window required in OECD 301F. Based on the screening level criteria, the test substance is not persistent (P). 

Bioaccumulation assessment: The calculated log Pow is 2.83, below the screening criteria of Log Kow ≤ 4.5. Based on the screening level criteria, the test substance is not bioaccumulative (B).

Toxicity Assessment: The screening assessment for environmental toxicity is based on acute aquatic toxicity testing. An acute toxicity study with the fathead minnow, Pimephales promelas, reported a 96-hour LC50value of 55.9 mg/L. An acute toxicity test with Daphnia magna reported a 48-hour EC50of 60 mg/L and an NOEC value of 4.5 mg/L.A study with Pseudokirchneriella subcapitata (formerly known as Selenastrum capricornutum) reported 72-hour ErC50values of 41.1 mg/L. The 72 -hour NOEC was reported as 4.5 mg n-pentyl propionate/L.  Since these values are higher than the 0.1 mg/L threshold for toxicity (T) in acute tests, the test substance is not T.

In a GLP study conducted according to OECD TG 471 (Bacterial Reverse Mutation Assay), UCAR n-pentyl propionate was not considered mutagenic in this bacterial reverse mutation assay at the highest tested concentration of 5000 μg/plate and in another GLP study conducted according to OECD TG 473 (In vitro Mammalian Chromosome Aberration Test), UCAR n-pentyl propionate was not genotoxic.There are no reproduction toxicity studies available for pentyl propionate, however there is a reproduction/developmental toxicity study for propyl propionate and 90-days repeated dose toxicity studies available for n-butyl propionate and primary amyl acetate. In all the available studies on analogue substances there is an absence of any (or any significant) reproduction toxicity and negative results noted in the in-vitro genotoxicity tests. Therefore, it is concluded that pentyl propionate is unlikely to cause any reproduction toxicity. There are no carcinogenicity studies available for pentyl propionate. Thus, based on the available data,n-pentyl propionate is neither classified as carcinogen, nor as mutagen, repro toxicant, T-R48, nor Xn-R48.