Registration Dossier

Diss Factsheets

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:
no hazard identified

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 > 100 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.


The dossier has been updated referring to Directive 1907/2006 EG (REACh); Article 22(1); (e), (g).


DNEL and PNEC values derived in the earlier version of the dossier have been removed due to the reasons already discussed in section 7.1.
Lysine intake in the western human diet is in the range 40–180 mg/kg bw/d. This corresponds to a maximum of 2.8- 12.6 g Lysine /day for an adult weighing 70 kg. Based on the available information there is no indication of a bioaccumulation potential and secondary poisoning is of no concern. L-Lysine has no potential to cause toxic effects if accumulated via the food chain.


 

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).