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EC number: 200-157-7 | CAS number: 52-89-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
Description of key information
In a cancerogenicity study rats were exposed to levels of 0, 0.25 % and 0.5 % L-Cysteine hydrochloride (0, 133/148 and 235/280 mg/kg bw. for males/females) in the drinking water for 108 weeks.
Histopathology revealed toxic effects on the kidneys, but no carcinogenic effects were observed.
Although no no-effect level was identified, the clear decline of toxic effects between the 2 dosages allows the estimation that a level of at least 13 mg/kg bw / day for both sexes should be a no-effect level.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LOAEL
- 130 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- One reliable study with detailed documentation of results. Sufficient animal numbers. The study is valid with restrictions.
- System:
- urinary
- Organ:
- kidney
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
It can be concluded that L-Cysteine hydrochloride and L-Cysteine hydrochloride
monohydrate is not carcinogenic based on the available data.
According to Regulation (EC) No.: 1272/2008 and subsequent regulations, the L-Cysteine hydrochloride as well as the monohydrate form is not classified with regard to Carcinogenicity
Additional information
In a carcinogenicity study groups of 50 male and 50 female rats were exposed to levels of 0, 0.25 % and 0.5 % L-Cysteine hydrochloride (0, 133 and 235 mg/kg bw. for males and 0, 148 and 280 mg/kg bw. for females) in the drinking water for 108 weeks.
L-Cysteine hydrochloride caused the following changes:
0.25 % in drinking water:
males: no significant effect,
females: reduced body weights,
histopathology: necrosis of the renal papillae in 2 of 43 animals,
hyperlasia of the kidney pelvis in one animal.
0.5 % in drinking water:
males: reduced body weights
histopathology: focal necrosis of the proximal tubules 2 of 41 animals
females: reduced: body weights
histopathology: necrosis of the renal papillae in 6 of 38 animals,
hyperlasia of the kidney pelvis in one of 38 animals
calcification of the renal papillae in 2 of 38 animals
focal necrosis of the proximal tubules in one of 38 animals.
Although no no-effect level was identified, the clear decline of toxic effects between the 2 dosages allows the estimation that a level of at least 13 mg/kg bw /day for both sexes should be a no-effect level.
It was concluded that L-cysteine hydrochloride does not induce any neoplasms when given orally to Rats (F344/DuCrj) for 108 weeks.
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