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PBT assessment

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PBT assessment: overall result

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

Persistence: The test item was determined as not P and not vP based on the screening criteria of ready biodegradability. The ready biodegradability of the test substance was assessed according to OECD guideline 301 F. The test substance underwent 77 % biodegradation after 28 days in the test conditions. Biodegradation started on day 1 and reached 72 % at the end of the 10-day window (days 1 to 11). Therefore, the test substance can be regarded as readily biodegradable according to this test.

Bioaccumulation: The test item was determined as not B and vB based on the screening criteria of Log Kow. The partition coefficient n-octanol/ water of the test item was determined by the Reverse Phase High Performance Liquid Chromatographic Method according to OECD Guidelines for Testing Chemicals, Method No. 117. The result is: Log Pow= 1.0.

Toxicity: The test item was determined as not T based on Annex XIII of REACH. The results of an in vitro gene mutation study in bacteria, an in vitro chromosome aberration study in mammalian cells and an in vitro gene mutation study in mammalian cells were all negative. Therefore, it is concluded that the test item is not genotoxic and does not warrant classification for mutagenicity. Furthermore, no systemic toxicological findings were detected in rats after repeated administration of the test item by the oral route at dose levels up to 1000 mg/kg bw/day for a period of 28 days and dose levels up to 5000 ppm/ day for a period of 98 days. Therefore, classification of the test item as STOT RE is not justified. The substance is not classified as toxic for reproduction based on the results of a combined repeated dose toxicity study with reproductive/developmental screening test (OECD 422) and pre-natal developmental toxicity test (OECD 414).

Information regarding the long-term aquatic toxicity of the test item is not available. However the substance is not expected to be toxic to the aquatic environment as it is considered to be readily biodegradable, the partition coefficient indicates that the substance is not bioaccumulative and the adsorption coefficient indicates that the substance is unlikely to adsorb to sediment and soil and bioaccumulate. Furthermore the substance is not classified as toxic to the aquatic environment based on short-term toxicity testing on invertebrates, short-term toxicity testing on fish and a growth inhibition study on aquatic plants, in accordance with Regulation 1272/ 2008.

Based on the above, the overall result of the PBT assessment is that the substance is not PBT/ vPvB.