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Diss Factsheets
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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-11-27 - 2013-04-24
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- L-Cysteine Hydrochloride Monohydrate
- Cas Number:
- 175.63
- Molecular formula:
- C3H7NO2S·HCl·H2O
- IUPAC Name:
- L-Cysteine Hydrochloride Monohydrate
- Test material form:
- solid: granular
Constituent 1
Test animals / tissue source
- Species:
- other: Fresh bovine eyes from Bos primigenius
- Details on test animals or tissues and environmental conditions:
- Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstrasse 2.
4, D-75217 Birkenfeld, Germany. The cattle were between 12 and 60 months old. The eyes were
transported to the test facility in Hank's balanced salt solution. Then the corneas were dissected and incubated in medium at 32 +-1 °C in an incubation chamber for one hour.
Test system
- Vehicle:
- other: Incubation Medium MEM
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 20% in 0.9% NaCl. A stock solution of the test item was prepared freshly on the day of the assay. The test item was dissolved in 0.9% NaCl. It was checked whether the solution was clear and the pH was mesured. pH: 0.78.
- Duration of treatment / exposure:
- Open chamber method, exposition time on the corneas was 4 h at 32 °C
- Duration of post- treatment incubation (in vitro):
- After an initial incubation of one hour, the medium was changed and the baseline opacity for each cornea was recorded.
Exposition time on the corneas was 4 h at 32 °C. After thorough rinsing with cMEM and with phenol red and a final rinsing with cMEM without phenol red, the final opacity value of each cornea was recorded at 570 nm. The cMEM in the front chamber was exchanged with a sodium fluorescin solution. The chambers were then closed and incubated for 90 +-5 min at 32+-1 °C. After incubation, the content of the posterior chamber was thoroughly mixed. Then the permeability of the cornea was measured as optical density of the liquid at 490 nm. - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 4 h of incubation
SCORING SYSTEM: opacity difference
TOOL USED TO ASSESS SCORE: spectral photometer Specord 205, Analytik Jena
Results and discussion
In vitro
Results
- Irritation parameter:
- other: opacity difference
- Value:
- 9.815
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean opacity difference
- Other effects / acceptance of results:
- Substances with an opacity difference < 55.1 may be considered as non-corrosive or not severely irritant.
The positive control showed very severe eye irritation.
Applicant's summary and conclusion
- Conclusions:
- According to OECD 437 L-Cysteine Hydrochloride Monohydrate is classified as "non-corrosive" and/
or " no severe irritant". - Executive summary:
An in vitro study was performed to assess the corneal irritation and damage potential of L-Cysteine Hydrochloride Monohydrate. Bovine corneas were incubated for 4 hours with a 20% solution of the test item in 0.9% NaCl solution. Afterwards the change of opacity was measured and compared to negative and positive control groups. The changes in opacity of the control groups, 0.402 and 80.746, met the validity criteria.
L-Cysteine Hydrochloride Monohydrate caused a change in opacity of 9.815.
According to OECD 437 L-Cysteine Hydrochloride Monohydrat is classified as "non corrosive" and/or "no severe irritant".
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