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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-11-18 to 2000-01-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adopted 21 Jul 1997
- Deviations:
- yes
- Remarks:
- high mortality at 200 mg/kg bw/day, thus only 2 valid dose levels were used
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Tripartite Harmonised Guideline on Genotoxicity: Specific Aspects of Regulatory Tests
- Version / remarks:
- adopted 1995
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese MAFF
- Version / remarks:
- adopted 1990
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPPTS-42193 Mammalian Eryhtrocyte Micronucleus Test
- Version / remarks:
- adopted Aug 1997
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
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
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate, UK
- Weight at study initiation: 22 - 31 g (males) and 21 - 27 g (females)
- Assigned to test groups randomly: yes
- Housing: in groups of no more than three animals of the same sex in appropriate caging, cleaned and dried before use
- Diet: laboratory chow diet (Special Diets Services Ltd), ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24
- Humidity (%): 54 - 61
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Concentration of test material in vehicle: 2.5, 5.0 and 10.0 mg/mL - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dosing formulations were made by mixing the test item with corn oil. Dilutions were made using corn oil. The test article formulations were inverted periodically during dosing and used within approximately 2.75 hours of initial formulation.
- Duration of treatment / exposure:
- 2 days
- Frequency of treatment:
- administration of 2 doses, 24 h apart
- Post exposure period:
- 24 h
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: intraperitoneal injection
- Doses / concentrations: 40 mg/kg bw, single administration
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow
Cell type: bone marrow cells - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
A range finding study was performed to find the maximum tolerated dose.
TREATMENT AND SAMPLING TIMES:
Two single doses were administered, one on each of two consecutive days. Sampling was performed 24 h after the last dose.
DETAILS OF SLIDE PREPARATION:
The cells were centrifuged and the serum was aspirated to leave one or two drops and the cell pellet. The pellet was mixed into this small volume of serum and the suspension was dropped on each of two coded slides. Slides were allowed to air-dry and fixed for 5 min in absolute methanol. Finally, the slides were stained with Giemsa (1:6 v/v in distilled water), rinsed, air-dried and cleared in xylene for 3 min.
METHOD OF ANALYSIS:
The proportion of polychromatic (immature, PCE) among total (polychromatic + normochromatic (NCE)) erythrocytes was determined for each animal by counting a total of 1000 erythrocytes (PCE + NCE).
2000 polychromatic erythrocytes were counted per animal to determine the presence of micronuclei. - Evaluation criteria:
- A test article is considered as positive in this assay if a statistically significant increase in the frequency of micronucleated PCE occurs at least at one dose, and if the frequency of micronucleated PCE at such a point exceeds the historical vehicle control range.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- clinical signs at 100 and 200 mg/kg bw/day
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY:
Dose levels were chosen based on an initial range finding study with groups of 3 male and female mice at a dose range of 50 to 400 mg/kg bw/day, once daily for two consecutive days. Death of all animals occured at dose levels of 300 and 400 mg/kg bw/day. Clinical symptoms were observed from 100 mg/kg bw/day. Consequently doses of 50, 100 and 200 mg/kg bw/day were chosen for the main study.
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei: The test item did not induce a statistically significant increase in the frequency of micronucleated PCEs up to 200 mg/kg bw/day. Group mean frequencies of micronucleated PCE were also similar to that seen in the vehicle controls. The number of micrunucleated PCE of the control animals fell within the historical control rate. The positive control substance induced a statistically significant increase in the frequency of micronucleated PCEs.
- Ratio of PCE/NCE: PCE/NCE ratios of the treated animals were similar to those of the vehicle controls.
- Statistical evaluation: Chi-square test
MORTALITY: Several animals (6/6 males and 2/6 females) of the high dose group died prior to the sampling time.
CLINICAL SIGNS: Clinical symptoms were observed at 100 and 200 mg/kg bw/day. At 100 mg/kg bw/day, lethargy and eye closure were noted. At 200 mg/kg bw/day, the animals showed abnormal breathing, lethargy, eye closure, prostration and abnormal gait.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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