Fatty acids, montan-wax, stearyl esters

PBT assessment

PBT assessment: overall result

Reference

Reference 1

Name:

Fatty acids, montan-wax, stearyl esters

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference 2

Name:

Fatty acids, montan-wax, stearyl esters

Type of composition:

boundary composition of the substance

State / form:

solid: particulate/powder

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

Reference substance:

Fatty acids, montan-wax, stearyl esters

PBT status:

the substance is not PBT / vPvB

Justification:

The PBT assessement of Fatty acids, montan-wax, stearyl esters (CAS 68308-30-5) 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

The substance is not readily biodegradable (28% in 28 d, OECD 301 F). Therefore, the substance is potentially P/vP.

 

Bioaccumulation

Experimental data for bioaccumulation is not available for the target substance Fatty acids, montan-wax, stearyl esters (CAS 68308-30-5) and the estimated log Kow is high (> 10.0, SPARC v4.6). However, a significant uptake and bioaccumulation of the substance is not expected in aquatic organisms based on the extremely high log Kow, environmental and toxicokinetic behaviour, as well as on (Q)SAR predictions for bioconcentration. For further details, refer to the IUCLID section on bioaccumulation.

The screening criterion based solely on the log Kow value most likely overestimates the true bioaccumulation potential of a substance because it does not account for environmental and toxicokinetic behavior. In fact, current knowledge suggests that log Kow values of 10 or above are indicators of reduced bioconcentration, as stated in the Guidance R.7c (ECHA, 2017) and R.11 (PBT/vPvB assessment v3.0, ECHA, 2017). Furthermore, additional data compiled on the environmental and toxicokinetic behavior of the substance, in combination with QSAR predictions for BCF values, provide additional evidence that the potential for bioaccumulation is likely low.

The substance has a low water solubility (< 0.539 mg/L, OECD 105), a high estimated adsorption potential (log Koc > 5.0) and a high estimated log Kow (> 10.0), indicating that it is highly lipophilic. If released into the aquatic environment, only low concentrations of the substance are expected to dissolve in the water phase. Rather, the substance is expected to sorb to organic matter, leading to an effective reduction of its bioavailability in the water column. Thus, the most relevant potential route of uptake by aquatic organisms is expected to occur via contact with or ingestion of particle-bound substance. However, its bioavailability in the sediment compartment is presumably very low based on its intrinsic physico-chemical properties (e.g. high sorption).

Thus, absorption of the parent compound is generally expected to be low. Furthermore, the biochemical processes involved in the metabolization of aliphatic esters, comprising enzymatic hydrolysis and subsequent metabolization of the corresponding hydrolysis products carboxylic acid and alcohol components, are ubiquitous in the animal kingdom. Thus, in the unlikely event of uptake and absorption by fish, the substance is expected to be rapidly metabolized via enzymatic hydrolysis into its corresponding fatty acids and fatty alcohols. It is well known from literature that the resulting hydrolysis products will also be effectively metabolized and excreted by fish (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990; Sand et al., 1973).

The predicted BCF values for this substance provide additional evidence that the potential for bioaccumulation in aquatic organisms is low. All (Q)SAR models consistently predicted very low BCF values of maximum 28.18 L/kg, which are clearly below the threshold values of 2000 L/kg and 5000 L/kg for bioaccumulative and very bioaccumualtive substances, respectively, as laid down by REACH Regulation (EC) 1907/2006 (Annex XIII, section 1).

Moreover, no adverse effects were observed in repeated dose toxicity studies.

 

Based on all the available information taken together, it is thus concluded that Fatty acids, montan-wax, stearyl esters (CAS 68308-30-5) has a low potential for bioaccumulation. Thus, it is concluded that the substance is not B or vB.

 

Toxicity

Neither short-term (aquatic algae, fish) nor long-term (aquatic algae) toxicity tests resulted in any adverse effects to aquatic organisms up to the limit of water solubility (< 0.539 mg/L). Furthermore, the substance is not classified according to the consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs). Therefore, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and it is concluded that the substance is not T.

This conclusion will be reevaluated, based on the results of the already commissioned long-term tests with invertebrates (OECD 211) and fish (OECD 210). The results will be submitted later based on ECHA communication/decision number TPE-D-2114565572-44-01/F. Reasons for the delay are summarized in the statement attached in IUCLID section 13.2 (Timelines for Ecotoxicity (and Associated Analytical Chemistry) Testing of Fatty acids, Montan-Wax, Stearyl Esters (CAS 68308-30-5)).

 

Conclusion

Thus, Fatty acids, Montan-Wax, Stearyl Esters (CAS 68308-30-5) is not PBT/ vPVB.