Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

9.3 µg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

93 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.93 µg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

1.2 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

3.86 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.386 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:

0.766 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

The calculated PNEC aquatic for the submission substance is 9.3 µg/L based on acute toxicity results for the three trophic levels. The lowest toxicity endpoint was observed in a growth inhibition test with Pseudokirchneriella subcapitata. Invertebrates are of similar sensitivity, while fish was by far the least sensitive trophic level. The main constituents of the submission substance were shown to be readily biodegradable with total nitrification and fulfilment of the 10-day window-requirement. Due to the short carbon chain lengths of active ingredients the submission substance does not show surface active properties and the octanol-water partition coefficient is very low. Distribution to sludge, sediment or soil therefore is highly unlikely. Because there is no potential for bioaccumulation, secondary poisoning needs not to be assessed.

PNECs for soil and sediment were calculated using the Equilibrium Partitioning Method. Details of the procedure are given in the "Justification" field for each PNEC.

Conclusion on classification

1     Classification according to Regulation (EC) 2008/1272 (CLP)

Classification according Regulation (EC) 2008/1272 (CLP) is performed independently for acute and chronic hazards. If data for chronic hazards are incomplete (data not available for all three trophic levels), chronic classification is performed both, based on acute data and based on available chronic data and the more stringent outcome is taken for final chronic classification.

Acute hazard category:

The lowest acute aquatic toxicity of three trophic levels was determined for algae (Pseudokirchneriella subcapitata) with an acute EC₅₀(72 h, growth rate) of 9.3 mg/L.

Thus, no acute classification results from the available acute aquatic ecotoxicity data.

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.

As substitute for an experimentally determined BCF in fish log K_OW is taken as an indicator of bioaccumulation potential. As log K_OW of the submission substance is clearly below the cut-off value according to CLP of 4.0 (≤1.3), the submission substance is regarded as non-bioaccumulative.

Rapid biodegradability according to CLP is given for substances which were assessed as “readily biodegradable” in screening studies (OECD 301) with a minimum of 60% O₂-depletion of theoretical maximum within 28 days and at the same time fulfillment of the 10-day-window. This is met by both active ingredients of the submission substance. The submission substance is therefore considered as rapidly biodegradable.

No chronic classification results for the submission substance from the available acute data on ecotoxicity, the degradation and bioaccumulation potentials.

 

Using available chronic data for algae (no other chronic data available), from the EC₁₀ (72 h, growth rate) of 1.0 mg/L and the NOEC (72 h, growth rate & yield) of 0.01 mg/L a chronic classification for rapidly degradable substances results. Thus, the final chronic classification according to regulation (EC) 2008/1272 (CLP) is the following:

Category Chronic 3, H 412: Harmful to aquatic life with long lasting effects, M-factor 1

2     Classification according Directive 67/548/EEC (DSD)

The lowest acute aquatic toxicity of three trophic levels was determined for algae (Pseudokirchneriella subcapitata) with an acute EC₅₀(72 h, growth rate) of 9.3 mg/L The submission substance is considered as rapidly biodegradable and without potential for bioaccumulation (log Kow << 3.0).

Thus, no classification according to Directive 67/548/EEC (DSD) is resulting.