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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.026 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.016 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.107 mg/kg sediment dw
Assessment factor:
1
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:
2.5 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.22 mg/kg food
Assessment factor:
90

Additional information

Conclusion on classification

For classification and labeling (PBT and CLP) the available (bulk) effect data are as a worst-case divided by a factor of 10, thus in fact it is assumed that 90% was sorbed where EUSES calculates that only 5% is sorbed using the Kd of 1763 L/kg.

The short term fish test (Akzo Nobel, 2017) with N-C16 -18 -alkyl-(even numbered, C18 unsaturated) trimethylpropane-1,3 -diamine (Methylated diamine) gave a LC50 of >0.016 mg a.i./L (Threshold test).

No acute short term daphnia test has been performed for this substance. As a realistic worst-case the long term parental EC50 for mortality (Scheerbaum, 2017) of >0.1 mg a.i./L is used for this endpoint.

The algae test (Scheerbaum, 2017) with Methylated diamine gave an ErC50 of 0.016 mg a.i./L.

 

The lowest short term toxicity observed is within the range: 0.001 < L(E)C50≤0.01 including the correction for mitigation for using the bulk approach.

 

This leads to an acute 1 classification and an M-factor of 100

 

For the long term environmental classification of Methylated diamine no read across from other substances is considered necessary as there are two long term study endpoints for Methylated diamine available and fish are based on the acute data and similar to primary alkyl amines, diamines, quaternary ammonium compound etc. expected to be less sensitive to Methylated diamine when compared to daphnia and algae.

There are two long term studies available with Methylated diamine.

The algae test (Scheerbaum, 2017) with Methylated diamine gave an ErC10 of 0.0132 mg a.i./L.

The long term daphnia test (scheerbaum, 2017) with Methylated diamine gave an EC10 (reproduction) of >0.1 mg a.i./L. The 21d NOEC for adult mortality is >0.1 mg a.i./L. 

 

The lowest long term toxicity value is within the range: 0.001 < EC10≤0.01 including the correction for mitigation for using the bulk approach.

 

This leads to a chronic 1 classification and an M-factor of 10 because the substance is rapidly biodegradable (RD)