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EC number: 203-328-4 | CAS number: 105-76-0
- 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: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test was performed according to OECD guideline 474 under GLP conditions.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Dibutyl maleate
- EC Number:
- 203-328-4
- EC Name:
- Dibutyl maleate
- Cas Number:
- 105-76-0
- Molecular formula:
- C12H20O4
- IUPAC Name:
- dibutyl but-2-enedioate
- Details on test material:
- Purity: 98 - 99%
Dibutylmaleinat, dibutylmaleate
Appearance: clear liquid
Batch: 215 71 35
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Supplier: Charles River WIGA GmbH
Numebr: 25 male and 25 female
Age: approximately 10 weeks at time of application
The test substance was administered via gavage once to 3 groups of of 5 male and 5 female NMRI mice per group.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- distilled water
- Details on exposure:
- Negative control: Dimethylsulfoxide (DMSO, E. Merck, D-6100 Darmstadt, No. 2931 p.a. dried, with max. 0.03% water) at a dose volume of 5 ml/kg bw.
Test material: 2000 mg - Frequency of treatment:
- Once
- Post exposure period:
- Animals were sacrificed 24, 48 and 72 hous p.a.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2000 mg/kg BW
Basis:
no data
- No. of animals per sex per dose:
- 5 per sex per dose
- Positive control(s):
- A single dose of 40 mg/kg of cyclophosphamide (Serva No 17681) 24 hours before sacrificed was used as positive control. Cyclophosphamide was dissolved in distilled water at a dose volume of 10 ml/kg bw.
Examinations
- Tissues and cell types examined:
- Bone marrow and peripheral blood cells
- Evaluation criteria:
- Number of micronucleated erythrocytes
- Statistics:
- P= 0.05 was selected for each test.
H-test of Kruskal and Wallis followed by the test of Nemeyi: differences between the dose groups and the negative control group.
U-test of Wilcoxon, Mann and Whitney: differences between the negative and the positive control groups and between the sexes within each group.
Composition of bone marrow, body weight: 1) analysis of variance followed by the Scheffe-test: comparison of more than two groups. 2) t-test: comparison of only two groups.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- There was no significant defference in the amount of nucleated cells, amount of polychromatic erythrocytes and rate of micronucleated normochromatic erythrocytes between the dosed groups and the negative control group. Increased micronuclei rates were o
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The test compound did not change the ratio of polychromatic erythrocytes to all erythrocytes. At all 3 time points slight increases in the number of micronucleated erythrocytes were obtained which were, however, not statistically significant. The results at 24 and 48 hours were also slightly in excess of the upper limits of historical control data. Positive control gave the expected response showing reliability in the system.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of this study, dibutyl maleate was not mutagenic in the mcironucleus in vivo test at 2000 mg/kg, but a slight clastogenic effect could not be excluded. - Executive summary:
A micronucleous in vivo test was performed according to OECD guideline 474. Based on a range finding study, a dose of 2000 mg dibutyl maleate per kg bw were administered once by gavage to 3 groups of 5 male and 5 female NMRI mice per group. Animals were killed 24, 48 and 72 hours post administration of the test substance. For the positive control, a single dose of 40 mg/kg cyclophosphamide was administered 24 hours before sacrifice and increased number of micronucleated erythrocytes was observed. The test compound did not change the ratio of polychromatic erythrocytes to all erythrocytes. At all 3 time of evaluation, no statistically significant increase in the number of micronucleated erythrocytes were obtained. Based on these conditions, it was concluded that dibutyl maleate is not mutagenic in the micronucleus in vivo study at the dose of 2000mg/kg, but a slight clastogenic effect could not be excluded without further evaluation.
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