Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
130 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.25 mg/kg sediment dw
Assessment factor:
50
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.125 mg/kg sediment dw
Assessment factor:
500
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
1 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

For DMA category members an extensive database of aquatic toxicity studies is available: Acute studies:

Ten reliable acute studies on freshwater fish exist for 7 category members with LC50 (96 h) values between 1.13 mg/L (C10 DMA; RL 1) and 0.18 mg/L (C18 DMA; RL 2).

In regard to acute tests on invertebrate toxicity (Daphnia magna) for four category members six reliable studies (reliability category 1 or 2) are available with EC50 (48 h) values between 930 µg/L (C10 DMA; RL 1) and 56 µg/L (C12-14 DMA; RL 1).

Acute toxicity to freshwater algae as represented by ErC50 (growth rate inhibition) values determined after 72 hours was investigated for five category members in eight reliable studies. Determined ErC50 (72 hours) values were between 26.8 µg/L (C10 DMA; RL1) and 9.9 µg/L (C16 DMA; RL1).

Chronic studies are available for invertebrates and algae:

For two category members reliable toxicity studies (reliability category 1) on Daphnia magna reproduction are available resulting in NOEC values (21 d, reproduction) between 36 µg/L (C12-14 DMA) and 100 µg/L (C16-18 DMA). Chronic invertebrate toxicity is not pronouncedly higher than acute toxicity exerted by DMA category members and compared to immobilization the reproductive endpoint is of similar sensitivity.

For all algae studies described above besides EC50(growth rate, 72 h) values used for acute assessment also EC10values (growth rate, 72h) were determined. These may be used for assessment of chronic toxicity towards freshwater algae. Thus, for five category members eight reliable studies are available resulting in EC10 (72 h) values between 2.6 µg/L (C16 DMA) and 8.5 µg/L (C16-18 DMA). No obvious relationship between chain length and toxicity exists.

Therefore, fish is clearly not the most sensitive organism group. Invertebrates are of higher sensitivity, and of special sensitivity are algae with EC50-values in the low µg/L range. Therefore, no further relevant information could be expected from tests on chronic fish toxicity. The lowest relevant chronic aquatic toxicity value was determined with freshwater green algae (Desmodesmus subspicatus). An ErC10 (72 hours) of 2.6 µg/L was derived for C16-DMA (based on a study with C16-18 DMA and further considerations as outlined in ES aquatic algae). In line with REACH Guidance R.10 an assessment factor of 10 is applied on this value for derivation of PNEC freshwater. This is justified because chronic data are available for the two acutely most sensitive trophic levels and it can be concluded with high certainty that chronic results on fish (acutely least sensitive) would not be lower than the chronic 10 per cent effect concentration determined for algae.

In further studies, toxicity of DMA category members to sediment and soil organisms was assessed. Organisms of both compartments proved to be considerably less sensitive than aquatic organisms:

For DMA category member C12-14 DMA and supporting substances reliable chronic studies assessing sediment toxicity on representatives of two different sediment organism groups (Nematoda, Oligochaeta) are available. The NOEC (28 d; reproduction & body weight) obtained for C20/22 ATQ in the sediment test with Lumbriculus variegatus of 62.5 mg/kg sed. dw may be regarded as a worst case estimate for sediment toxicity of DMA category members and is used for PNEC sediment derivation.

For DMA category member C12-14 DMA and supporting substances reliable studies on acute and chronic toxicity to earthworm (Eisenia fetida), toxicity to terrestrial plants (Seedling emergence and growth test) and soil microorganisms (Nitrogen Transformation Test) are available. Terrestrial plants proved to be the most sensitive organism group: In a reliable test performed according to OECD 208 and compliant to GLP shoot height of rape proved to be most sensitive upon exposure to C12-14 DMA and a NOEC (21 days) of 10 mg/kg soil dw was determined and is used for PNEC soil derivation.

Secondary poisoning is not relevant for DMA category members:

Based on the low BCF fish and BCF worm (see IUCLID Cahapter 5.3 bioaccumulation and biomagnification is not expected and secondary poisoning unlikely.

Conclusion on classification

Classification according directive 2008/1272/EEC (CLP)

Classification according directive 2008/1272/EEC (CLP) is performed independently for acute and chronic hazards.

Actute hazard category:

The highest acute aquatic toxicity of three trophic levels was determined for the freshwater green alga Desmodesmus subspicatus with an geometric mean EC50 (72 h; growth rate) for DMA category members of 16.5 µg/L. Due to the difficult substance properties of DMA category members the key studies were performed in natural river water. Sometimes mitigating effects are observed for river water tests compared to tests involving synthetic water. This was not the case for results on algal toxicity of DMA. Where reliable studies for both test types are available for comparison (C10 DMA, C16 DMA) effect concentrations observed in the river water test were even lower than those determined using synthetic dilution water. Therefore, a mitigating factor is not required. The algal EC50 (72 h; growth rate) to be used for classification is therefore 16.5 µg/L.

This results in the following acute classification:

Category Acute 1, H400: Very toxic to aquatic life

M-factor: 10

 

Chronic hazard category:

Using available acute data, decisive for a possible chronic classification is failure or fulfillment of (1) rapid degradability and / or (2) presence or absence of a bioaccumulation potential.

BCF fish were estimated using the Arnot & Gobas (2003) ADME model. The highest calculated value for the DMA Category members is 223 L/kg and this value is below the CLP criteria of 500. This means the DMAs are regarded as non-bioaccumulative.

Rapid biodegradability according to CLP is given for substances which were assessed as “readily biodegradable” in screening studies (OECD 301). This is met by DMA category members.

Under these circumstances, no chronic classification results for DMA category members from the available acute data on ecotoxicity.

Using available chronic data (algae, invertebrates): The lowest chronic (no) effect concentration of the two trophic levels with chronic data available was determined for the freshwater green algaDesmodesmus subspicatus: An EC10 (72 h; growth rate) of 2.56 µg/L was determined for C16 DMA. Due to the difficult substance properties of DMA category members the study was performed in natural river water. Sometimes mitigating effects are observed for river water tests compared to tests involving synthetic water. This was not the case for results on algal toxicity of DMA. Where reliable studies for both test types are available for comparison (C10 DMA, C16 DMA) effect concentrations observed in the river water test were even lower than those determined using synthetic dilution water. Therefore, a mitigating factor is not required. The algal EC10 (72 h, growth rate) to be used for classification is therefore 2.6 µg/L.

This results in the following chronic classification, taking into account ready biodegradability:

Category Chronic 1, H410: Very toxic to aquatic life with long lasting effects

M-factor: 1

 

Classification according directive 67/548/EC (DSD)

The highest acute aquatic toxicity of three trophic levels was determined for the freshwater green algaDesmodesmus subspicatuswith an geometric mean EC50 (72 h; growth rate) for DMA category members of 16.5 µg/L. Due to the difficult substance properties of DMA category members the key studies were performed in natural river water. Sometimes mitigating effects are observed for river water tests compared to tests involving synthetic water. This wasnotthe case for results on algal toxicity of DMA. Where reliable studies for both test types are available for comparison (C10 DMA, C16 DMA) effect concentrations observed in the river water test were even lower than those determined using synthetic dilution water. Therefore, a mitigating factor is not required. The algal EC50 (72 h; growth rate) to be used for classification is therefore 16.5 µg/L.

The DMA category is readily biodegradable and has no potential for bioaccumulation (see IUCLID Chapter 5.3).

Thus, the following classification according to directive 67/548/EC (DSD) is resulting:

N; R50 Very toxic to aquatic organisms