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EC number: 200-562-9 | CAS number: 63-68-3
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. Study was originally judged Klimisch 1. However, according to the "Practical guide 6: How to report read-across and categories" the maximum score for read-across is 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study performed before REACH become into force
Test material
- Reference substance name:
- DL-methionine
- EC Number:
- 200-432-1
- EC Name:
- DL-methionine
- Cas Number:
- 59-51-8
- Molecular formula:
- C5H11NO2S
- IUPAC Name:
- methionine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 days
- Weight at study initiation: 246-313 g (excluding positive control group), positive control group: 230- 335 g
- Fasting period before study: overnight
- Housing:in pairs/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 50% +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.9% NaCl solution
- Concentration / amount:
- lnduction (test day 1 ): Two (2) mL of the D,L-Methionin suspension (50%) were applied to the left flank . The exposure time was 6 hours. This
procedure was repeated on test days 7 and 14 using 2 mL of the same test substance concentration per animal.
Challenge (test day 29): Two weeks after the last epicutaneous application the right flanks of the same animals were shaved and depilated for a
further epicutaneous application. Again 2 mL of the above mentioned D,L-Methionin concentration were applied but to the right flank. The
exposure time was 6 hours.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.9% NaCl solution
- Concentration / amount:
- lnduction (test day 1 ): Two (2) mL of the D,L-Methionin suspension (50%) were applied to the left flank . The exposure time was 6 hours. This
procedure was repeated on test days 7 and 14 using 2 mL of the same test substance concentration per animal.
Challenge (test day 29): Two weeks after the last epicutaneous application the right flanks of the same animals were shaved and depilated for a
further epicutaneous application. Again 2 mL of the above mentioned D,L-Methionin concentration were applied but to the right flank. The
exposure time was 6 hours.
- No. of animals per dose:
- 10 animals: Negative control (vehicle)
20 animals: D,L-Methionin (50% in 0.9% NaCI solution tor all 4 stages)
20 animals: Positive control: 2% aqueous p-phenylene diamine dihydrochloride solution - Positive control substance(s):
- yes
- Remarks:
- 2% aqueous p-phenylene diamine dihydrochloride solution
Results and discussion
- Positive control results:
- The positive control 2% aqueous p-phenylene diamine dihydrochloride solution revealed pronounced sensitising properties. An erythema of grade 1 was noted in 13 of 20 animals during the challenge phase 54 hours after start of treatment.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 2 ml 50% suspension in 0.9% NaCl solution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 2 ml 50% suspension in 0.9% NaCl solution. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 2 ml 50% suspension in 0.9% NaCl solution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 2 ml 50% suspension in 0.9% NaCl solution. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the present test conditions D,L-Methionin revealed no sensitising properties in guinea-pigs in a skin sensitisation test according to
E. V. BUEHLER. The positive control 2% aqueous p-phenylene diamine dihydrochloride solution revealed pronounced sensitising properties.
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