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EC number: 445-630-0 | CAS number: -
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 1,2-diacetoxybut-3-ene
- EC Number:
- 421-720-5
- EC Name:
- 1,2-diacetoxybut-3-ene
- Cas Number:
- 18085-02-4
- Molecular formula:
- C8 H12 O4
- IUPAC Name:
- 1,2-diacetoxybut-3-ene
- Details on test material:
- - Name of test material (as cited in study report): 3,4-diaetoxy-1-butene
- Physical state: Clear,colorless liquid
- Purity: >99%, The purity and stability of the test substance were determined by the Chemical Quality Services Division
- Stability under test conditions: The purity and stability of the test substance were determined by the Chemical Quality Services Division
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: strain Swiss CD-l, Cr1 :CD-1®(ICR)BR, were received from Charles River Laboratories Inc ., Raleigh, NC .
- Age at study initiation: 47 days
- Weight at study initiation: 19 .88 g to 26 .72 g
- Fasting period before study: no data
- Housing: The mice were housed two or three per cage in suspended, stainless-steel, wiremesh cages. Cages and racks were washed once per week . Absorbent paper, used to collect excreta, was changed at least three times per week.
- Diet (e.g. ad libitum): commercial diet, PMI certified rodent diet 5002 pellets. The feed was analyzed by the manufacturer for concentrations of specified heavy metals, aflatoxin, chlorinated hydrocarbons, organophosphates, and specified nutrients.
- Water (e.g. ad libitum): water were available ad libitum for the duration of the study
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 41-56
- Air changes (per hr): no details
- Photoperiod (hrs dark / hrs light): photoperiod of 12 hours, from 6a.m. to 6 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Duration of treatment / exposure:
- animals were dosed with the test substance and were euthanatized at 24 and 48 hours after dosing for extraction of the bone marrow
- Frequency of treatment:
- single treatment
- Post exposure period:
- 24h and 48h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 500, 1000, and 2000 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Route of administration: oral gavage
- Doses / concentrations: 80 mg/kg
cyclophosphamide was included only at the 24-hour sampling time.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
In the preliminary study, it was determined that the LD 50/3 of the test substance in male and
female mice was > 2000 mg/kg, the maximum dose level suggested in the OECD Guideline
474 for the mouse micronucleus assay .
In the main study, one male in the high-dose group exhibited signs of hypothermia and impaired respiration, and died
on the day following dosing . In order to maintain equal numbers of animals in all dose groups,
this animal was replaced for femur harvest with an additional animal that had been dosed at
2000 mg/kg . Clinical signs in the other animals included decreased feces output in high-dose
females, and weakness in three males from the high-dose group ; all three of these males
became moribund following the observed weakness . It is known that the moribund condition of
these males did not affect the outcome of the study because the PCE/NCE ratios for each of
these animals was similar to other animals in the study .
Statistical analysis revealed a statistically significant trend for depression in bone marrow
among the female groups at the 24 hour sacrifice with respect to dose . Although no single
value was significantly different from the negative control, this trend provides direct evidence
of bone marrow exposure to the test substance. The positive control groups,
treated with 80 mg/kg cyclophosphamide, showed significant bone marrow depression when
compared with the negative controls . No significant effect of the test substance on micronuclei
per 1000 PCE was detected . By contrast, the animals treated with 80 mg/kg cyclophosphamide
showed highly significant increases in micronucleated PCEs as compared with the negative
control, and statistically significant decreases in percent PCE (bone marrow depression) at 24
hours for both the male and female groups .
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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