Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

STP

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

 

PBT assessment:

 

 

Persistent

Bioaccumulation

Toxicity

Endpoints

 

 

PBT and vPvB Criteria fulfilled?

Readily biodegradable

 

 

No

Log Pow <-3.3

 

 

 

No

L(E)C50 > 100 mg/l

NOAEL = 914 mg/kg bw/d

 

 

No

Persistence

The substance was found to be readily biodegradable under aerobic conditions. Hence, the substance appears not to fulfill the screening criteria for persistence (P), as laid down in the guidance on information requirements part C (ECHA, May 2008) and Annex XIII of REACH Regulation.

 

Bioaccumulation

The substance was assessed to have a low bioaccumulation potential as it has a low log Kow. Therefore, L-lysine HCl appears not to fulfill the screening criteria for bioaccumulation (B), as laid down in the guidance on information requirements part C (ECHA, May 2008) and Annex XIII of REACH Regulation.

 

Toxicity

The substance does not fulfill the screening criterion for toxicity as all L(E)C50 values for freshwater organisms are >0.1 mg/l. Besides, the test substance is not classified as carcinogenic and there is no evidence of chronic toxicity. The substance does not fulfill the criteria for toxicity (T) as laid down in the guidance on information requirements part C (ECHA, May 2008) and Annex XIII of REACH Regulation.

Conclusion on classification

As L-lysine HCl has been determined experimentally to be readily biodegradable, has low bioaccumulation potential and low toxicity it should not be considered as a PBT or vPvB and not classifed for the environment (CLP and DPD).