Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
5.64 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
10.1 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:
101 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Ecotoxicity studies with Oleic-acid based IQAC, DMS quaternised show acute toxicity values < 1 mg/L for aquatic invertebrates and algae.

Short-term toxicity to aquatic organisms

Fish: 96h-LC50 =1.8mg/L for Leuciscus idus (OECD 203)

Crustacea: 48h-EC50 = 105 μg/L forDaphnia magna (OECD 202)

Algae or aquatic plants: 72h-EyC50 = 356 μg/L for Pseudokirchneriella subcapitata (OECD 201)

 

Long-term toxicity to aquatic organisms

35d NOEC > 100 µg/l for Desmodesmus subspicatus

21d EC10 > 145 µg/l for Daphnia magna with Oleic acid based IQACs, DMS quaternised (CAS-No. 931 -745 -8)

 

Biodegradation in water: Inherently biodegradable

 

Bioaccumulation: BCF = 10.7 (read-across from supporting substance partially unsaturated IQAC, DMS quaternised (structural analogue or surrogate)

 

Ozone layer: Due to the ionic structure and a corresponding negligible vapour pressure of the substance a relevant concentration of the substance in the atmospheric compartment is not expected. Furthermore, according to reaction with OH radicals, the half-life of degradation is short with 3 hours at 25 °C.The registration substance is not expected to reach the atmospheric stratosphere and therefore is not expected to present a danger to the structure and/or the functioning of the stratospheric ozone layer.

The registration substance is classified with regard to environmental effects.

Toxicity towards aquatic micro-organisms is expected to be of no concern for sewage treatment plants. Long-term exposure of aquatic organisms is therefore unlikely.

Bioaccumulation in organisms is considered to be low. Therefore, secondary poisoning through the food chain is of no concern for Oleic-acid based IQAC, DMS quaternised.

Conclusion on classification

Classification and labeling according to GHS Regulation EC No. 1272/2008 (including 2. ATP):

 

Results from acute tests with fish, Daphnia and algae are available. Long-term studies are available for Daphnia and Algae.

 

Evaluation of acute aquatic toxicity:

Summary of acute toxicity key values:

Fish: EC50= 1.8 mg/L

Daphnia: EC50 = 0.105 mg/L

Algae: EC50 = 0.330 mg/L

 

The lowest short-term aquatic toxicity test result is the calculated EC50 (48 h) = 0.105 mg/L for Daphnia magna (OECD 202) (Acute toxicity test).

This value is well below the threshold value for classification of < 1 mg/L; therefore classification for acute aquatic toxicity is required (Aquatic Acute 1, H400).

 

Evaluation of long-term aquatic toxicity:

Initial considerations:

Oleic-acid based IQAC, DMS quaternised is inherently biodegradable and hydrolysable. The log Kow is ≥ 4 (log Kow of > 5.7), however the experimental determined BCF (10.7) of the read across substance is far below the threshold of < 500.

 

Summary of long-term toxicity key values:

Daphnia magna: long-term 21 d EC10 > 145µg/L

Algae: long-term 35d NOEC =100 µg/L

 

For daphnia and algae there is adequate chronic toxicity data available for two trophic levels, classification was assessed based on the criteria outlined in Table 4.1.0(b)(i) substance is not rapidly biodegradable.

 

Based on the chronic toxicity of 0.1 mg/L and the threshold value≤0.1 mg/L, Category Chronic 1 has to be assigned.

 

For the other trophic level (fish) only acute toxicity data are available, classification has to be evaluated based on acute data according to the criteria given in Table 4.1.0(b)(iii):

 

Based on the EC50= 1.8 mg/L for fish and the threshold value of >1 to≤10 mg/L for fish Category Chronic 2 has to be assigned.

Classification for long-term aquatic toxicity has to be the most stringent outcome of both evaluations. 

 

In conclusion oleic-acid based IQAC, DMS quaternised has to be classified as hazardous to the environment with:

Aquatic Acute 1, H400

Aquatic Chronic 1, H410

according to Regulation (EC) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labeling of Chemicals (GHS).

According to Directive 67/548/EEC oleic-acid based IQAC, DMS quaternised has to be classified as hazardous to the environment as R50/53.

Acute toxicity values are below the value of≤ 1 mg/L and the substance is not readily biodegradable.