(Z)-N-octadec-9-enylhexadecan-1-amide

PBT assessment

PBT assessment: overall result

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

Persistence P

According to ready biodegradable studies (Z)-N-octadec-9-enylhexadecan-1-amide (CAS No. 16260-09-6) is not readily biodegradable according to the OECDcriteria (42% (ThO2) after 30 days (OECD 301 D) and 27% (ThO2) after 42 days (DGXI/400/84)). Simulation tests investigating the degradation of the substance in sediment/water and in soil are available.

The degradation of (Z)-N-octadec-9-enylhexadecan-1-amide (CAS No. 16260-09-6) has been investigated in OECD 308. The decline of the test substance in the overall system corresponded to estimated DT50 values of 19.6 days (Calwich Abbey Lake) and 25.2 days (Emperor Lake) with final mineralization range of 42% at 105 days (Calwich Abbey Lake) and 40.6% at 105 days (Emperor Lake).

In OECD 307, the substance degraded slowly in four different soils incubated under aerobic conditions with estimatedDT50 values, for primary degradation, between 226 and 418 days with final mineralization range from 8.5% at 120 days (Kennett soil) to 15.4% at 120 days (South Witham soil).

Based on the data presented above the substance is considered to meet the vP criterion.

Conclusion on P / vP properties: vP (P)

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

Biomagnification of the substance is investigated by an OECD 305 by dietary route. This study is currently ongoing. Results will be implemented as soon as they are available.

BCF values calculated by Arnot Gobas equation are available as supporting studies. Calculation based on BCFBAF v3.01, regression based, BCF is 3.47 L/kg whole body w.w. and 0.89 L/kg w.w. (including biotransformation rate).

Thus, the substance does not meet the criterion for bioaccumulation and is not considered to be bioaccumulative (B) or very bioaccumulative (vB).

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:

·    All available short-term effect concentrations are > 0.1 mg/L (fish, aquatic invertebrates, algae) and no long-term effects with NOEC or EC10 <0.01 mg/L were determined for the substance. No effect was observed.

·   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"):

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.