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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
In a combined study with Norwegian rats over 6 generations possible effects on fertility and developmental toxicity of L-Cysteine hydrochloride monohydrate were tested. The substance was added to flour in concentrations of 0, 35, 350 and 3500 ppm. With this flour bread was baked. After the baking a powder was produced and was mixed to a diet. This resulted in an estimated daily intake of L-cysteine hydrochloride monohydrate of 0, 2.7, 27 and 270 mg/kg bw..
No adverse effects on fertility occurred in the rats during the experiment even at the high level of Lcysteine hydrochloride monohydrate treatment.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 270 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Klimisch 2: reliable with restrictions
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
L-Cysteine hydrochloride monohydrate was added to flour in concentrations of 0, 35, 350 and 3500 ppm. With this flour bread was baked. After the baking the bred was sliced, freeze-dried, crushed and milled. This powder was mixed to a diet. The diets contained about 77% of bread crumbs on dry weight.
An animal weight of 100 g and a daily feed intake of 10 g diet per animal and day is estimated. 77% of milled bread was added to this diet. This resulted in an estimated daily intake of L-cysteine hydrochloride monohydrate of 0, 2.7, 27 and 270 mg/kg bw.. All in all 7 generations were studied.
Recorded are number born, litter weight at birth, numbers weaned and litter weight at weaning, carcass, liver and kidney weights of all slaughtered aninmals, post mortem examination for gross lesions. In the 0 and 3500 ppm groups the principal characteristics of the response to the treatment were measured:
rate of change per generation in litter size and weight at birth and at weaning, and the rate of change in the size of the cracasses, livers and kidneys of both adults and weaning rats.
Breeding rats of the fifth generation at about 150 days of age and receiving the diet with the highest treatment (3500 ppm) were examined histopathologically. They showed no lesions atypical in normal rats of that age.
No obvious adverse effects on fertility occurred in the rats during the experiment even at the high level of L-cysteine hydrochloride monohydrate treatment.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
L-Cysteine is essential in the body and human exposure through food has at least the same order of magnitude as the doses used in the prenatal developmental toxicity study (OECD 414). Human cells handle large quantities of L-Cysteine and that this amino acid is an essential component of normal cellular function. Overall, from all available data it can be excluded that Cysteine-HCl has toxic effects on the developing organism. Further testing of Cysteine-HCl in a prenatal developmental toxicity study (OECD 414) in mammals is not justified and makes no sense for animal welfare reasons.
Justification for classification or non-classification
From the detailed evaluation of the available reliable data in comparison with the criteria set out in the CLP-regulation, it is concluded that L-cysteine hydrochloride monohydrate as well as the anhydrous form does not need to be classified with regard to reproduction toxicity.
Additional information
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