Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
300 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Data relevant for classification:

 

Degradation

 

Biodegradation: 100.7% of BOD (OECD 301F)

 

Bioaccumulation

log Kow: -2.31 (OECD 107)

 

Aquatic acute toxicity

For fish:                             96 h, NOEC (Leuciscus idus melanotus (golden orfe)) > 4 g/L

For aquatic invertebrates:    48 h, EC50(Daphnia magna): 980 mg/L

For algae/aquatic plants:     72 h, ErC50(Pseudokirchneriella subcapitata): 397 mg/L

 

Aquatic chronic toxicity

For fish:                             not available

For aquatic invertebrates:    21 d, NOEC (Daphnia magna): 3.99 mg/L; read-across

For algae/aquatic plants:     72 h, NOErC (Pseudokirchnerella subcapitata): 100 mg/L

 

Conclusion:

 

Based on the data above, 2 -amino-2 -(hydroxymethyl)-1,3 -propanediol (TRIS AMINO) is considered to be rapidly degradable and to have low bioaccumulation potential. The acute aquatic toxicity L(E)C50 values are > 300 mg/L for fish, aquatic invertebrates and algae, thus does not warrant an aquatic acute classification. The substance met the criteria of readily biodegradable within the 10 -day period, thus does not warrant an aquatic chronic classification.

In conclusion, TRIS AMINO does not need to be classified and labelled as environmental hazard according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2ndATP).