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EC number: 221-882-5 | CAS number: 3268-49-3
- 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
- Study period:
- 1979-04 to 1979-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- no negative control group; instead positive control group (20 animals tested positive with 50.000 IU/100 g of Penicillin-G-Na); maximum non-irritating concentrations used for induction instead of highest to cause mild-to-moderate skin irritation; no details on animals and environmental conditions, no details on erythema and edema of individual animals
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 Jul 1992
- Deviations:
- yes
- Remarks:
- no negative control group but positive control group (50.000 IU/100 g of Penicillin-G-Na); maximum non-irritating concentrations used for induction instead of highest to cause mild-to-moderate skin irritation; topical induction for 24 h instead of 48 h
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed in 1979 before the alternative OECD guidelines (LLNA and in vitro test methods) were available.
Test material
- Reference substance name:
- 3-(methylthio)propionaldehyde
- EC Number:
- 221-882-5
- EC Name:
- 3-(methylthio)propionaldehyde
- Cas Number:
- 3268-49-3
- Molecular formula:
- C4H8OS
- IUPAC Name:
- 3-(methylthio)propionaldehyde
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- - Source: Tierzüchterei Willy Krispien, Ahrensburg, Germany
- Animal body weight at study initiation: 300 - 320 g
- no data on housing, diet, water supply and environmental conditions
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal induction on Day 1: 1%
epicutaneous induction on Day 7: 5% - Day(s)/duration:
- intradermal induction: single treatment; epicutaneous induction: 24 h
- Adequacy of induction:
- other: Selection of concentration based on the results of the pre-test (determination of maximum non-irritating concentrations)
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 5% in physiological saline
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
The primary irritation by the test substance upon intracutaneous and epicutaneous exposure was tested in a pre-experiment. Graded dilutions of the test substance in physiological saline (2-fold dilution steps) were applied. The animals were induced with 0.1 mL test substance intradermally, followed by epicutaneous induction of 1 mL test substance one week later under occlusive conditions. Intracutaneous doses were tested in 5 animals each; each animal received up to 5 different concentrations. Epicutaneous doses were tested in 5 animals, each; but only one concentration per animal. Skin reactions were evaluated 24 h post application. Concentrations for the main experiment were chosen to be the highest non-irritating concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: 1:1 (v/v) mixture complete Freund's adjuvant (FCA) and distilled water
Injection 2: 1% test substance in phosphate buffered saline (PBS)
Injection 3: 1% test substance in a 1:1 mixture of complete Freund's adjuvant (FCA) and PBS
Epicutaneous: One week after the injections, a 2 x 4 cm patch of gauze was soaked with 5% test item formulated in PBS and applied to the test site. The treated areas were covered with alufoil and fixed with an elastic bandage for 24 h.
- Control group: Not included in the study.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 2 weeks after epidermal induction (Day 20)
- Exposure period: 24 h
- Test groups: test substance
- Concentrations: 5% formulation in PBS
- Evaluation (hr after challenge): 48 h - Challenge controls:
- Not included in the study.
- Positive control substance(s):
- yes
- Remarks:
- Penicillin-G-Na
Results and discussion
- Positive control results:
- All animals induced intracutaneously, epicutaneously and challenged with 50.000 IU / 100 g of Penicillin-G-Na tested positive in this study.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 1% intradermal, 5% epicutaneous; challenge 5%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- no
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- induction: 50.000 IU / 100 g intradermal, 50.000 IU / 100 g epicutaneous; challenge 550.000 IU / 100 g
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- no
- Reading:
- 2nd reading
- Group:
- negative control
- Remarks on result:
- other: No negative control included in this study.
Any other information on results incl. tables
No mortality or adverse clinical observations were reported in this study. In addition, the result of the first reading time point after challenge were not reported.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- CLP: Skin sens. 1, H317 according to Regulation (EC) No. 1272/2008
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