Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.032 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.16 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.003 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
32 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
6.35 mg/kg sediment dw

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.635 mg/kg sediment dw

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Derivation of PNECs

The PNECfreshwater, PNECmarine water, PNECintermittent release and PNECstp were derived by application of an assessment factor. This procedure is described in detail in the ECHA REACH Guidance of May 2008, Chapter R.10 ("Characterisation of dose [concentration]-response for environment").

The PNECs for sediments (freshwater and marine water) are derived using the Equilibrium Partitioning Method (EPM) which is in concordance with ECHA REACH Guidance R.10 (“Guidance of Information Requirements and Chemical Safety Assessment, Chapter R.10: Characterisation of dose-response for environment”). The required normalized organic-carbon soil coefficient (Koc) value for the target substance was derived using the regression model of Baker et al. (1997) to estimate the logKoc (Koc ) from logPow. The logPow of Reaction products of diphosphorus pentaoxide and alcohol C7-9-iso, C8 rich, salted with 2-ethylhexylamine (UVCB substance) was determined for three main constituents of the substance (OECD Guideline 123; Fox, 2013); however, in this case, the value of 4.28 (from the anionic di-alkyl phosphate species) is used as worst-case assumption. According to the mentioned regression model, the Koc is calculated to be 9095.78 (logKoc = 0.903 x logPow + 0.094).

Regarding the PNECsoil, no experimental results are available based on the fact that no information requirements exist for this environmental compartment according to Annex VIII of REACH Regulation (EC) 1907/2006. The Equilibrium Partitioning Method (EPM) is also not applicable since some required substance properties (i.e. Henry Law Constant; HLC) are not determinable. Therefore, no PNEC have been derived for this compartment.

Furthermore, no PNECs were derived concerning the atmospheric compartment (PNECair) and the food chain (PNECoral). These values are considered as not relevant based on the chemical structure and intrinsic properties of the target substance.    

Environmental classification and labelling

Valid experimental results are available for evaluating biodegradation, metabolism and toxicity of the target substance (Reaction products of diphosphorus pentaoxide and alcohol C7-9-iso, C8 rich, salted with 2-ethylhexylamine) (biodegradation only) as well as for the reliable read-across substance (Phosphoric acid, mono- and di-(C8 -C10) ester, compds. with C12-14 amine) towards aquatic vertebrate and invertebrate species. Based on the structural similarity and substance characteristics of both substances, all results from the read-across substance can be equivalently used for the target substance. Physico-chemical, toxicological and ecotoxicological properties are likely to be similar. For a detailed justification and further information about this procedure, please refer to the separate read-across statement (Chemservice S.A., 2013d).

Both substances, the target substance (Schäfer and Matthews, 2009 and Clarke, 2009) as well as the read-across substance (Mead, 1999a), showed biodegradability in standard laboratory degradation tests. None of them can be considered as rapidly degradable (although also not as persistent) in the environment. Beside acute toxicity data for three trophic levels (i.e. fish, daphnids and algae), also adequate long-term data are available (using daphnids as test species). All obtained No Observed Effect Concentrations (NOECs) were found to be > 1 mg/L (i.e. NOEL(21d): 1.6 mg/L loading rate WSF for Daphnia magna; NOEL(72h): 5 mg/L loading rate WSF for Scenedesmus subspicatus). Based upon the obtained experimental results and in reference to the second Adaptation to Technical Progress (ATP) of Regulation (EC) No. 1272/2008, the target substance (Reaction products of diphosphorus pentaoxide and alcohol C7-9-iso, C8 rich, salted with 2-ethylhexylamine) has not to be classified and labelled with respect to environmental hazards.

Conclusion on classification

In accordance with Regulation (EC) No. 1272/2008 (Classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No. 1907/2006), the target substance (Reaction products of diphosphorus pentaoxide and alcohol C7-9-iso, C8 rich, salted with 2-ethylhexylamine) has not to be classified and labelled with respect to environmental hazards.