Registration Dossier
Registration Dossier
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EC number: 211-519-9 | CAS number: 657-27-2
Ecotoxicological Summary
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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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