Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, diacetates

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

5.12 µg/L

Assessment factor:

50

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

1.5 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.512 µg/L

Assessment factor:

500

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

0.34 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

2.38 mg/kg sediment dw

Assessment factor:

50

Extrapolation method:

assessment factor

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

238 µg/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:

10 mg/kg soil dw

Assessment factor:

100

Extrapolation method:

assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

Due to intrinsic properties of amine containing cationic surfactants river water ecotoxicity tests deliver reproducible test results with limited uncertainty. As river water has a mitigating effect on ecotoxicity due to sorption of the amines to and suspended matter a factor of 10 should be applied to correct for the lower ecotoxicity observed.

Conclusion on classification

The environmental fate and ecotoxicological properties of the Amines, N-(C16-18 and C18unsatd. alkyl)trimethylenedi-, diacetates (CAS 1313206-64-2) are equivalent to the properties of diamines. Indeed, it can be expected that the ecotoxicity of the diamines acetate in aqueous solution is not related to acetates therefore the ecotoxicological data of the diamines can be used for the registered salt. For more details, please see to the read-across justification document attached in the corresponding aquatic Endpoint Study Records.

 

If no data are available on a salt, effects may be read-across from the anion or cation, whichever has the most toxic effect. As the effect endpoints were related to only one of the ions, therefore the classification of the salt use the effect concentration multiplied by the molecular weight ratio of the substance (according REACH guidance document R7b v4, June 2017 p 81).

 

The classification of the registered substance according to CLP regulation 1272/2008 EC is aquatic acute category I, H400 M=10 and aquatic chronic category II defined by the environmental data detailed below.

 

The classification has been established considering that the substance is rapidly biodegradable and have a low lipophilic behaviour with an experimental value of log Kow <4.

 

Aquatic acute category

 

96h-LC50 fish was 1,5 mg/L

 

48h-EC50 invertebrates was 0,395 mg/L (corrected by a factor 10 due to river water testing, that yields to EC50 = 0,0395 mg/L).

 

72h-ErC50 algae was 0,69 mg/L (corrected by a factor 10 due to river water testing, that yields to ErC50 = 0.069 mg/L)

As all ecotoxicity values (corrected and uncorrected) are below 1 mg/L. Based on these results it is proposed to classify the Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, diacetates as Acute Category 1

The corresponding M-factor is 10 based on the EC50 of 39.5 µg/L (21 d EC50 parental daphnia of 395 µg/L and applying an additional correction factor of 10 for mitigation).

 

The registered substance is therefore considered Aquatic Acute Category I, H400 M=10.

 

 

Aquatic chronic category

 

Long-term test result for fish is not required.

 

21d-NOEC for daphnia was 1 mg/L (corrected by a factor 10 due to river water testing, that yields 0,1 mg/L)

 

72h-EC10 for algae was 0,26 mg/L (corrected by a factor 10 due to river water testing, that yields 0,026 mg/L)

 

 

When chronic toxicity data are available these should be used for classification for chronic aquatic hazard. Considering the lower sensitivity of fish it is considered justified to use the long-term daphnia and algae test results for the chronic classification. The lowest EC10 value obtained is for Algae, ErC10 = 256 µg/L. Correcting this value for mitigation (river water) with the realistic worst-case correction factor of 10 leads to EC10 for classification of 25.6 µg/L. Thus the substance is classified as Chronic Category 2.