Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
20 000 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

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

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

There are several guideline studies available for freshwater fish. The studies are all static and the test concentrations are measured in most of the studies. The lowest observed effect concentration is a 96 -h LC50 value of 40613 mg/l in a study with Oncorhynchus mykiss (Beak Consultants Limited, 1995).

The effect concentration determined in marine fish is a 96 -h LC50 of >10,000 mg/l in Scophthalmus maximus (Halliburton Energy Services, 2004). An EC50 value could not be determined, therefore this study will not be used in the assessment.

  

There are several guideline studies available for freshwater invertebrates. The most critical study for is therefore chosen as the key study. For freshwater invertebrates the lowest observed effect concentration is a 48-h LC50 value of 18340 mg/l in Ceriodaphnia dubia (Pillard, 1995). In marine water, the lowest 96-h LC50 is 18800 mg/l in Mysidopsis bahia (new name: Americamysis bahia) (ARCO Chemical Company, 1990). Both values will be used in the assessment.

 

One chronic guideline test is available with the freshwater invertebrate Ceriodaphnia. The 7-d NOEC is 13020 mg/l (measured concentration) (Pillard, 1995).

This value will be used in the assessment.

 

Experimental data are available with fresh water and marine algae. In fresh water, the 96-h EC50 is 19,000 mg/l inPseudokirchnerella subcapitata (reported as Selenastrum capricornutum) and the 14 -d NOEC is 15,000 mg/l (ARCO Chemical Company, 1990). In marine water, the 96-h EC50 is 19,100 mg/l in Skeletonema costatum. These values will be used in the assessment.

 

Reliable test data are available for toxicity to microorganisms. In a near guideline test with Pseudomonas putidaan 18-h NOEC of >20,000 mg/l was determined in a growth inhibition test. Nominal values were reported (The Dow Chemical Company, 1992). This value will be used in the assessment.

 

A GLP compliant guideline study is available for the sediment compartment. The 10-d LC50 is 6983 mg/kg to the marine amphipod Corophium volutator (Halliburton Energy Services, 2004). As only long-term testing can be used in the hazard assessment according to the REACH.

Conclusion on classification

According to 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.

Three short-term L(E)C50 of each trophic levels (fish, invertebrates and algae) and two long-term NOEC from two trophic levels (invertebrates and algae) are available. The lowest no effect concentration is the 7-d NOEC of 13,020 mg/l for the freshwater invertebrate Ceriodaphnia). Based on the result of the octanol/water partition coefficient (Log Kow = - 1.07), monopropylene glycol is not expected to significantly accumulate in aquatic organisms. Furthermore, the substance is found to be readily biodegradable. For these reasons, monopropylene glycol is not classified in Annex I of Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.