Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.083 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.83 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.008 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

In accordance with article 2(7)(b) and Annex V 6., REACH the hydrate free form of L-Cysteine hydrochloride is registered. L-Cysteine hydrochloride monohydrate (CAS 7048-04-6, hydrate part of the molecule = 10.25 %) is the manufactured and imported substance and was therefore in many cases used for testing.
It is generally accepted that water and especially water of crystallisation has no toxicologically relevant effects. Therefore, the effect levels of L-Cysteine hydrochloride monohydrate can be used to calculate the corresponding dosages of L-Cysteine hydrochloride (anhydrous (free of water of crystallisation)).
Thus, the conclusion on hazard assessment and classification holds true for the anhydrous form as well.
For L-Cysteine hydrochloride as well as for the monohydrate form: no classification according to the criteria laid out in regulation (EC) 1272/2008 (CLP). This is justified as follows.
available for classification relevant ecotoxictity/ environmental fate data:
- EC50 (fish (96 h)) > 100 mg/L
- EC50 (daphnia (48 h)) > 100 mg/L
- ErC50/ ErC10 algae (72 h) = 83/ 22 mg/L.
- readily biodegradable
The lowest effect concentrations are in the range of 10 to 100 mg/L and the substance is readily biodegradable. Therefore, L-Cysteine hydrochloride as well as L-Cysteine hydrochloride monohydrate do not need to be classified as hazardous to the aquatic environment according to the criteria of table 4.1.0 of CLP-regulation (EC) 1272/2008.