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EC number: 213-979-6 | CAS number: 1070-70-8
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 1,4-butanediyl diacrylate
- EC Number:
- 213-979-6
- EC Name:
- 1,4-butanediyl diacrylate
- Cas Number:
- 1070-70-8
- Molecular formula:
- C10H14O4
- IUPAC Name:
- 4-(prop-2-enoyloxy)butyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 5 - 8 weeks
- Assigned to test groups randomly: yes
- Housing: Makrolon cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: Limited solubility of the test substance in water - Duration of treatment / exposure:
- 24 (all treatments), 48 h (control and high dose)
- Frequency of treatment:
- once
Doses / concentrationsopen allclose all
- Remarks:
- Females: 1500, 750, 375mg/kg
- Remarks:
- Males: 750, 375, 187.5mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide: 20 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION
The slides were stained in eosin and methylene blue (modified May-Gruenwald solution or Wrights solution) for about 5 minutes.
After having briefly been rinsed in purified water, the preparations were soaked in purified water for about 2 - 3 minutes.
Subsequently, the slides were stained in Giemsa solution (15 ml Giemsa, 185 ml purified water) for about 15 minutes.
After having been rinsed twice in purified water and clarified in xylene, the preparations were mounted in Gorbit-Balsam. - Evaluation criteria:
- Acceptance criteria
The mouse micronucleus test is considered valid if the following criteria are met:
- The quality of the slides must allow the identification and evaluation of a sufficient number of analyzable cells, i.e. >= 2000 PCEs and a clear differentiation between PCEs and NCEs.
- The ratio of PCEs/NCEs in the untreated animals (negative control) has to be within the normal range for the animal strain selected.
- The number of cells containing micronuclei in negative control animals has to be within the range of the historical control data both for PCEs and for NCEs.
- The two positive control substances have to induce a significant increase in the number of PCEs containing small and large micronuclei within the range of the historical control data or above.
Assessment criteria
A finding is considered positive if the following criteria are met:
- Significant and dose-related increase in the number of PCEs containing micronuclei.
- The number of PCEs containing micronuclei has to exceed both the concurrent negative control and the highest value of the historical control range.
A test substance is considered negative if the following criteria are met:
- The number of cells containing micronuclei in the dose groups is not significantly above the negative control and is within the historical control data.
Results and discussion
Test resultsopen allclose all
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- mortality at 1500mg/kg
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Since mortality occured in 1500mg/kg males, this dose could not be scored. An additional experiment was performed, adding a new low dose of 187.5mg/kg as well as the 48h evaluation for the new high dose of 750mg/kg for males. Concurrent controls were included in this experiment and valid.
The slight increase observed in the 48h control samples (females) and in the low dose (females) had no relation to dosing and was not confirmed when twice the number of PCEs were recounted.
There was no significant difference in the percentage of PCEs per erythrocytes between groups.
Any other information on results incl. tables
Males | |||||
Interval | Exp. | Micronuclei | Range | PCEs relative to control | |
Vehicle control | 24 | 2 | 1.1 ‰ | 2-6 | 100% |
Positive control | 24 | 2 | 16.9 ‰** | 51-86 | 104% |
187.5mg/kg | 24 | 2 | 1.5 ‰ | 2-10 | 104% |
Vehicle control | 24 | 1 | 1.9 ‰ | 2-10 | 100% |
Positive control | 24 | 1 | 13.5 ‰** | 34-71 | 130% |
375mg/kg | 24 | 1 | 1.7 ‰ | 5-8 | 115% |
750mg/kg | 24 | 1 | 1.9 ‰ | 3-12 | 125% |
Vehicle control | 48 | 2 | 1.1 ‰ | 3-7 | 100% |
750mg/kg | 48 | 2 | 1.3 ‰ | 1-9 | 97% |
Females | |||||
Interval | sample size | Micronuclei | Range | PCEs relative to control | |
Vehicle control | 24 | 4000 | 1.7 ‰ | 3-7 | 100% |
Vehicle control | 24 | 8000 | 1.5 ‰ | 10-14 | 100% |
Positive control | 24 | 4000 | 12.8 ‰** | 28-79 | 94% |
375mg/kg | 24 | 4000 | 2.5 ‰ | 5-16 | 85% |
375mg/kg | 24 | 8000 | 1.7 ‰ | 8-21 | 89% |
750mg/kg | 24 | 4000 | 1.3 ‰ | 3-7 | 97% |
1500mg/kg | 24 | 4000 | 1.5 ‰ | 4-8 | 79% |
Vehicle control | 48 | 4000 | 2.4 ‰ | 6-14 | 100% |
1500mg/kg | 48 | 4000 | 1.8 ‰ | 2-11 | 94% |
** significantly different from control
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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