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PBT assessment

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PBT assessment: overall result

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

PERSISTENANCE ASSESSMENT


 


Two screening test the the C18 and the C22 component shows a biodegradation of 80 and 77 % after 28 days. The OECD 308 siumulation test shows a DT50 value of 29 and 56.7 day in the sediment systems. The available OECD 307 test shows a DT50 soil between 23.2 and 41.4 days. This informations in combination with the OECD 303 A test (biodegradtion 96 and 91 %) . This information shows that the substance is not persistent in the environment. But in an OECD 309, [14C]Carbon dioxide was a major product of degradation in both the low and high application rate of the surfactant [14C]Docosyltrimethylammonium chloride.  The rate of transformation was moderate and consistent throughout the study, where the DT50 (half-life) was 101 and 166 days for the high and low application rates respectively.  No major metabolites were identified, but one minor metabolite was present within the high application rate vessels and identified as desaturated [14C]Docosyltrimethylammonium chloride (– 2H).


 


BIOACCUMULATION ASSESSMENT


Due to the low Log Coctanol/Cwater partitoning coefficient of C20/22 ATQ of 3.3 the potential for bioaccumulation is low (see IUCLID Chapter 4.7).
The 'B' criteria for C20/22 ATQ are NOT fulfilled as e.g. the Log Coctanol/Cwater partitioning coefficient is < 4.5 and therefore BCF <= 2000.


The results of the OECD 305 test showed an ambiguous finding regarding the carbon chain length. Due to the high adsorption of the test substance it can be assumed that a certain amount of the substance is adsorbed on the fish skin. In order to differentiate between the fraction on the fish skin and the fraction in the fish fillet, further investigations was necessary.
The additional analytical data regarding the distrubution in fish body (filet) and skin is available. Based on these data the BCF of all the chain-length are below 2000. A weighted BCF of 835 is used for chemical safety assessment in Chesar.


 


TOXICITY ASSESSMENT


Ecotoxicity


For the aquatic compartment C20/22 ATQ is most toxic to daphnia (chronic NOEC (21d) is 0.13 mg/l). The 'T' criteria of the PBT / vPvB Assessment for C20/22 ATQ based on the lowest aquatic (chronic) toxicity result is not fulfilled as the toxicity value of 0.13 mg/L is above the chronic toxicity criteria of 0.01 mg/L for the aquatic compartment.


Human health


1. 'T' criteria related to CMR


The registration substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1,2 or 3) or reprotoxic (category 1,2 or 3) under DSD 67/638/EEC and not as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 2B) or toxic to reproduction (category 1A, 1B or 2) under CLP 1272/2008. Therefore the 'T' criteria of the PBT / vPvB Assessment is not fulfilled.


2. 'T' criteria related to Repeated dose effects


Due to specific target organ effects in a repeated dose study the registration substance is classified under CLP 1272/2008 as STOT Rep. 2 and under DSD 67/648/EEC as Xn; R48/22. Based on this classification the 'T' criteria for the PBT / vPvB Assessment is fulfilled.

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