Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
478 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
141 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
47.8 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
562 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
8 020 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
802 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
1 600 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

No substance-specific data are available for monoethanolamine oleate, however read-across from monoethanolamine is used for the assessment to meet the majority of the standard REACH information requirements. Monoethanolamine oleate is the salt of monoethanolamine and oleic acid. As oleic acid is exempted for registration according to Annex V of REACH Directive 2006/121/EC, the focus is only on the monoethanolammonium cation of monoethanolamine oleate (for more details see reporting format for the analogue approach in Appendix A.2). There is a complete set of data available for monoethanolamine. Besides short-term tests on fish, invertebrates and algae also long-term studies are available.

Guideline studies for short- and long-term toxicity are available for freshwater fish. The critical effect concentrations for monoethanolamine are a 96-h LC50 value of 349 mg/L in carp (Cyprinus carpio) (Huels, 1997a) and a 30-d NOEC of 1.2 mg/L in Japanese killifish (Oryzias latipes) (NITE, 2006). After correction for molecular weight, the effect concentrations for monoethanolamine oleate of 1963 mg/L for short-term toxicity and 6.75 mg/L for long-term toxicity in fish will be used in the assessment.

For invertebrates short- and long-term toxicity guideline studies are available for Daphnia magna. The critical effect concentrations for monoethanolamine are a 48-h EC50 value of 65 mg/L (Huels, 1997b) and a 21-d NOEC 0.85 mg/L (NITE, 1996a). After correction for molecular weight, the effect concentrations for monoethanolamine oleate of 366 mg/L for short-term toxicity and 4.78 mg/L for long-term toxicity in daphnids will be used in the assessment.

A growth inhibition guideline study is available for freshwater algae. The critical effect concentrations for monoethanolamine are a 72-h EC50 value of 2.5 mg/L and a 72-h NOEC of 1 mg/L in Pseudokirchneriella subcapitata (NITE, 1996b). After correction for molecular weight, the effect concentrations for monoethanolamine oleate of 14.1 mg/L for short-term toxicity and 5.62 mg/L for long-term toxicity in algae will be used in the assessment.

For the toxicity of microorganisms a respiration inhibition guideline study with domestic activated sludge is available (BASF, 1991). The 30-min EC10 for monoethanolamine is >1,000 mg/L. After correction for molecular weight, an effect concentration for monoethanolamine oleate of >5,624 mg/L for STP microorganism toxicity will be used in the assessment.

Studies with terrestrial organisms are not available. Because the calculated log Kow for monoethanolamine is low (-1.31), it is expected that monoethanolamine, and also the monoethanolamine cation in monoethanolammonium oleate, will mainly partition to the water compartment. Therefore, direct and indirect exposure of the terrestrial compartments is not expected.

Conclusion on classification

Based on Directive 67/548/EEC, results of validated structure activity relationships and expert judgment may also be taken into account where appropriate with regard to classification and labelling of substances.

Based on all available data for daphnids, fish and algae, monoethanolamine oleate need not to be classified according to Directive 67/548/EEC nor for EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.