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EC number: 265-025-3 | CAS number: 64704-23-0
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-05-09 to 2012-11-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study from supporting substance (structural analogue)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cystine
- EC Number:
- 200-296-3
- EC Name:
- Cystine
- Cas Number:
- 56-89-3
- Molecular formula:
- C6H12N2O4S2
- IUPAC Name:
- cystine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Name: L-Cystine
CAS No.: 56-89-3
Physical State: solid powder
Colour: white or off-white
Decomposition: 260-261 °C
Purity: 99%
Storage Conditions: at room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: 16-17 weeks old
- Weight at study initiation: >2 kg
- Housing: Semi barrier in an air-conditioned room, housed in ABS - plastic rabbit cages, floor 4200 cm2
- Diet (e.g. ad libitum): Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 1013), rich in crude fibre
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: adequate acclimatisation period (at least 5 days) under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature 18 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): at least 10x/hour
- Photoperiod (hrs dark / hrs light): articifical light, sequence being 12 hours light, 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): not applicable
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours (24 and 48 hours also recorded)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was not rinsed 24 hours after the application.
SCORING SYSTEM: Annex VI to Commission Directive 2001/59EC; Annex B.5 to Commission Regulation (EC) No. 440/2008, L 142, Annex I of Regulation (EC) 1272/2008, GHS - Globally Harmonized System of Classification and Labelling of Chemicals, third revised edition, July 2009.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
At the end of the observation period the treated eyes were examined with the aid of a fluorescein solution. The eyes were rinsed with physiological saline 0.9% NaCl after the examination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- The test item produced irritant but not corrosive effects in all animals
- Other effects:
- - Lesions and clinical observations:
no mortalities nor significant clinical signs of toxicity were observed
- Ophthalmoscopic findings: upon fluorescien examinations at the end of the observation period of 72 hours, no corneal lesions were found in any animal
- Histopathological findings: not specified
- Effects of rinsing or washing: The eyes were not rinsed after the application
- Other observations: conjunctival redness and discharge were observed in all animals. Iris lesion was observed in animal #1.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single ocular application of the test item L-Cystine to rabbits at a dose of 0.1 g produced irritant effects, which were fully reversible within 72 hours. Neither mortalities nor significant clinical signs of toxicity were observed.
- Executive summary:
A single ocular application of the test item L-Cystine to rabbits at a dose of 0.1 g produced irritant effects, which were fully reversible within 72 hours. Neither mortalities nor significant clinical signs of toxicity were observed. The test item under the conditions of the present study does not meet the GHS criteria for eye irritation.
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