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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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Name:
4-(octadecylamino)-4-oxoisocrotonic acid - SIP
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
Name:
4-(octadecylamino)-4-oxoisocrotonic acid - LE
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment for the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

 

Persistence assessment

Biodegradation of the test item was determined in a screening test for ready biodegradability. The study indicated that the test item is not readily biodegradable according to OECD criteria. Therefore, the substance is potentially persistent in the environment. Thus, the substance is considered likely to meet the P/vP criteria based on the available data. 

 

Bioaccumulation assessment

Due to the log Kow value of 2.53 bioaccumulation is not expected. Thus, the substance does not meet the screening criterion for bioaccumulation and is not considered to be bioaccumulative (B) or very bioaccumulative (vB) in accordance with ECHA Guidance R.11 (ECHA, 2017).

 

Toxicity assessment

Acute aquatic toxicity studies are available for fish, aquatic invertebrates and algae. No effects were observed for all three trophic levels. Moreover, the substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to the consolidated version of Regulation (EC) No. 1272/2008 and all further amendments (ATPs). Thus, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.

 

In conclusion, the substance is not PBT/vPvB.