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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
(Z)-N-Octadec-9-enylhexadecan-1-amide
Type of composition:
legal entity composition of the substance
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

8.1.1. PBT/vPvB criteria and justification

8.1.1.1. Assessed substance: Substance itself

8.1.1.1.1. Persistence assessment

Other evidence of non-P / non-vP properties

The substance is only partly biodegradable in water according to an OECD guideline 301 D and a repetitive die away test following DGXI/400/84, EEC 1984 (Balk and Hantink-de Rooij, 1989) but not readily biodegradable and therefore it could not be excluded that the substance has a potential to persist in the environment if it is exposed to soil. However the release to surface waters, and thereby indirect exposure of soil, is considered as marginally as the substance will be physically removed in sewage treatment plants due to the low water solubility and high adsorption potential. An extensive discharge via a STP effluent is unlikely. Furthermore the substance is assessed to be neither acutely nor chronically toxic nor to accumulate in organisms. Thus, it is not expected to pose a risk on soil organisms (long-term study is planned). Considering this information, testing for this endpoint is not deemed necessary since the substance is not expected to cause an environmental risk.

Conclusion on P / vP properties: P not vP

8.1.1.1.2. Bioaccumulation assessment

Evidence of non-B / non-vB properties

Criteria based on Annex XIII of REACH

-Not B / vB based on BCF <= 2000 L/kg: Arnot-Gobas BCF & BAF Methods (assuming a biotransformation rate of zero):

Estimated Log BCF (upper trophic) = -0.047 (BCF = 0.8971 L/kg wet-wt)

Estimated Log BAF (upper trophic) = 1.341 (BAF = 21.94 L/kg wet-wt)

Other evidence of non-B / non-vB properties

The substance is highly insoluble in water. Thus a significant uptake of the substance by aquatic organisms through the water phase is not expected. Considering this, one can assume that the availability of the substance in the aquatic environment is generally very low, which reduces the probability of uptake by aquatic organisms

 This assumption is supported by QSAR calculations using BCFBAF v3.01. BCF/BAF values calculated for the substance exhibit a low bioaccumulation potential (Knoell Consult GmbH, 2012). A calculated BCF/BAF of 0.89 L/kg (SRC BCFBAF v3.01 Arnot Gobas, upper trophic level) indicates that the substance has a low bioaccumulation potential.

 The substance is characterised by a low water solubility and high log Koc leading to a low bioavailability. Due to its higher molecular weight, no extensive metabolism of the substance is expected but rather direct elimination. In conclusion, a bioaccumulation or biomagnification through the food chain of the substance is not expected. It can hence be concluded that the high log Kow, which indicates a potential for bioaccumulation, overestimates the bioaccumulation potential of the substance.

Conclusion on B / vB properties: not B/vB

8.1.1.1.3. Toxicity assessment

Evidence of non-T properties

Criteria based on Annex XIII of REACH

-Not T based on criteria laid down in Annex XIII of REACH:

·   EC10 / NOEC >= 0.01 mg/L for marine / freshwater organisms (long-term toxicity):Short term toxicity data for invertebrates and algae are available for (Z)-N-octadec-9-enylhexadecan-1-amide (CAS No. 16260-09-6). The test substance is highly insoluble in water and no effects were observed to aquatic algae and daphnia in the range of water solubility of (Z)-N-octadec-9-enylhexadecan-1-amide (CAS No. 16260-09-6).

·   Substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC (or the DSD) or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008 (or CLP Regulation) (see also section "3. Classification and labelling"):The substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

·   No other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008: The substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

Conclusion on T properties: not T

8.1.2. Summary and overall conclusions on PBT or vPvB properties

Overall conclusion:

Based on the assessment described in the subsections above the submission substance is not a PBT / vPvB substance.