Trifluoro(trifluoromethoxy)ethylene

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

bioaccumulation in aquatic species: fish

Data waiving:

study technically not feasible

Justification for data waiving:

the study does not need to be conducted because direct and indirect exposure of the aquatic compartment to the substance is unlikely

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING

In accordance with section 2 of REACH (Regulation (EC) No 1907/2006) Annex XI the bioaccumulation study required in section 9.3.2 Annex IX of REACH (Regulation (EC) No 1907/2006) is not proposed by the registrant as PMVE is a gas at ambient condition with a limited water solubility and an high tendency to rapidly volatilise from water to the air. Bacause of its gaseous nature experimental testing is expected to be unfeasible.
Moreover, no significant release to environment is expected and in case of an accidental emission, on the grounds of the physico-chemical properties of PMVE and the results on environmental fate obtained from EQC Fugacity III Model (Version 2.02, The Canadian Centre for Environmental Modelling and Chemistry, May 2003), the substance is expected to primarily and rapidly partition to the atmosphere. No significant exposure of the aquatic environment is consequently expected.

Reference 2

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

QMRF and QPRF are attached

Guideline:

other: REACH guidance on QSARs R.6

Principles of method if other than guideline:

Regression of LogKow against experimental data with appropriate fragment based correction factors. The underlying model and validation has been published in the peer reviewed literature (Meylan, W.M., et al, Environ. Toxicol. Chem., 1999, 18(4), 664-672).

GLP compliance:

no

Specific details on test material used for the study:

SMILE: FC(F)(F)OC(F)=C(F)F

Radiolabelling:

not specified

Details on sampling:

not applicable

Vehicle:

no

Details on preparation of test solutions, spiked fish food or sediment:

not applicable

Test organisms (species):

other: not applicable

Route of exposure:

other: not applicable

Test type:

other: QSAR calculation

Water / sediment media type:

not specified

Hardness:

not applicable

Test temperature:

not applicable

pH:

not applicable

Dissolved oxygen:

not applicable

TOC:

not applicable

Salinity:

not applicable

Nominal and measured concentrations:

not applicable

Details on estimation of bioconcentration:

Basis information
- Estimated log Kow: 1.42

Type:

BCF

Value:

3.993

Basis:

whole body w.w.

Calculation basis:

other: QSAR calculation

Remarks on result:

other: BCFBAF v3.0, EPISUITE v4.00

Details on kinetic parameters:

not applicable

Metabolites:

not applicable

Results with reference substance (positive control):

not applicable

Details on results:

not applicable

Reported statistics:

not applicable

An experimental BCF is not available for the substance. In the absence of measured data the use of a QSAR to predict the BCF is an appropriate technique to use. The use of the BCF QSAR in EPIWIN is appropriate for PMVE as its log Kow falls within the applicability domain of the model.

Validity criteria fulfilled:

not applicable

Description of key information

In accordance with section 1 of REACH (Regulation (EC) No 1907/2006) Annex XI the bioaccumulation study required in section 9.3.2 Annex IX of REACH (Regulation (EC) No 1907/2006) is not proposed by the registrant as PMVE is a gas at ambient condition with a limited water solubility and an high tendency to rapidly volatilise from water to the air. Due to the gaseous nature of the substance and the consequent difficulty to appropriately test PMVE and provide meaningful results testing for bioaccumulation in aqueous media is not proposed.
Moreover, on the basis of the properties of PMVE, in case of release, the substance is expected to  primarily and rapidly distribuite to the atmosphere. No significant exposure of aquatic compartment is expected, therefore the assessment of the bioaccumulative properties  in water compartment is not considered relevant for PMVE.

Key value for chemical safety assessment

BCF (aquatic species):

3.993 L/kg ww

Additional information

PMVE is a gas at ambient condition with limited water solubility and a high tendency to rapidly volatilize from water to the air.

Due to the gaseous nature of the substance and its distribution to the atmosphere, as well as the consequent difficulty to appropriately test PMVE and provide meaningful results, no experimental bioaccumulation data are available and no testing is proposed by the Registrants.

However, in order to evaluate the bioaccumulation hazard profile of PMVE despite the fact that it is expected to rapidly partition to the atmospheric compartment, the BCFBAF (v.3.00, EPI Suite v.4.0) has been be applied.

 The model prediction for PMVE yielded a BCF of 3.993 and a log K_owof 1.42.

According to Annex XIII of Regulation (EC) No 1907/2006 and to the Guidance on information requirements and chemical safety assessment Chapter R.11 (PBT Assessment, May 2008), a substance does not fulfil the criterion “bioaccumulative (B) ” or “very bioaccumulative (vB) ” if the BCF is below 2000 and 5000, respectively, or the log Kow is below 4.5, therefore PMVE is not expected to be bioaccumulative.