Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.234 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.44 µg/L

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
2.04 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.204 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:
1.084 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
3.33 mg/kg food
Assessment factor:
300

Additional information

Acute toxicity results are available for fish and algae. Long term toxicity results are available for aquatic invertebrates and algae. No significant effects were observed in the acute fish and long term daphnia test during exposure to the water accommodated fraction (WAF) of C36 -alkylenediamines. In the algae test significant effects were observed in the WAF. C36 -alkylenediamines is a strongly sorbing substance which sorbs strongly to algae during the test. In the OECD guideline 201 (paragraph 40), it is acknowledged that quantification at the end of the study can be difficult for such substances, particularly when low concentrations are concerned. In such case, if the substance is stable under test conditions, the use of measured initial concentrations is considered acceptable.

For this reason it is considered justified to use the measured initial concentration to base the dose response on and not the mean measured concentration as most of the measured initial test substance concentration is actually either sorbed to algae or in the test solution.

 

As fish are less sensitive when compared to algae and daphnia, no further long term testing with fish is proposed to avoid further vertebrate testing.

Conclusion on classification

Classification according to GHS

Acute (short-term) aquatic hazard

The lowest acute toxicity data is observed for algae. The 72 h ErC50based on measured initial test concentration is 44.3 µg/L based on active ingredient. The substance therefore needs to be classified as Acute 1: H400; very toxic to aquatic life.

 

Long-term aquatic hazard

Acute toxicity data are available for fish and algae and no effects were observed for fish and anticipated for daphnia due to the low water solubility of the test substance. For algae effects were observed in the WAF of the test substance. The observed 72 h ErC50is 44.3 µg/L based on measured initial concentration.

Reliable chronic toxicity data are available for crustacea and algae. No significant effects were observed in the long-term daphnia test. The 72 h ErC10value for algae is 11.7 µg/L based on measured initial concentration.

Further chronic fish testing has been waived to avoid unnecessary animal testing as the available data suggest that fish are less sensitive to the substance as algae. Therefore additional information from a chronic fish test is not expected to alter the proposal to classify the substance as hazardous to the aquatic environment. In addition the bioaccumulation potential of the substance is low based on the calculated log Kow of >14. This log Kow value is above the lower trigger value of 4.5 but clearly above the upper trigger value 10 (REACH guidance R.11 PBT assessment). Despite of the extreme low water solubility of < 0.0002 mg/L, removal via biodegradation of 74.9 % was observed in the sewage treatment simulation test (OECD 303A). Based on this later observation the substance is considered to be inherently biodegradable.

Based on the available information it can be concluded that chronic toxicity is ≤ 0.1 mg/L and the substance is considered to be “not rapidly biodegradable” and that therefore the substance does meet the criteria for classification with Category Chronic 1: H410: Very toxic to aquatic life with long lasting effects

 

Safety net classification

The safety net classification does not apply. The substance is based on the available data classified as acute 1 and chronic 1. Therefore the substance needs no classification as Chronic Category 4.

 

Conclusion classification according to GHS

Based on the results from the acute aquatic toxicity and chronic aquatic toxicity and taking into account the low bioaccumulation potential and “not rapidly biodegradability, the substance needs to be classified as hazardous to the environment according to the CLP Regulation 1272/2008.

 

Classification according to 67/548/EEC (DSD)

Acute aquatic toxicity is <1 mg/L and the substance is not rapidly biodegradable. Chronic toxicity is <0.1 mg/L and the substance has a low bioaccumulation potential (log Kow of >14). The substance should therefore be classified as R50/53 “hazardous for the environment” very toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment according to Directive 67/548/EEC.

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