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EC number: 227-774-4 | CAS number: 5977-14-0
- 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: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP and EPA guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EPA guideline: In vivo mammalian bone marrow cytogenetic tests: micronucleus assay. HG-Chromo-Micronuc, August 1982
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Acetoacetamide
- EC Number:
- 227-774-4
- EC Name:
- Acetoacetamide
- Cas Number:
- 5977-14-0
- Molecular formula:
- C4H7NO2
- IUPAC Name:
- acetoacetamide
- Details on test material:
- - Name of test material (as cited in study report): Acetoacetamid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, SPF breeding colony
- Age at study initiation: about 7 weeks
- Weight at study initiation: males: 27 - 35 g; females: 21 - 29 g
- Housing: in fully air-conditioned rooms in Macrolon cages (Type 3), on softwood granulate in groups of 5 animals
- Diet: rat/mice diet Altromin 1324 (Altromin-GmbH, Lage/Lippe), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
- Animal identification: fur-marking with KMn04 and cage numbering
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2
- Humidity (%): 55 +-10
- lighting time: 12 hours dally
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- deionized water
- Duration of treatment / exposure:
- Killing time: 24, 48 or 72 hours after administration of test compound and negative control
Killing time: 24 h after administration of positive control - Frequency of treatment:
- single treatment
- Post exposure period:
- Killing time: 24, 48 or 72 hours after administration of test compound and negative control
Killing time: 24 h after administration of positive control
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
500 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
2750 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
5000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 males and 5 females in each dose group at each killing time
- Control animals:
- yes
- Positive control(s):
- Endoxan(R) (50 mg/kg body weight p.o.)
Examinations
- Tissues and cell types examined:
- bone marrow
- Details of tissue and slide preparation:
- The animals were killed by carbon dioxide asphyxiation 24, 48 or 72 hours after application. For each animal, about 3 ml foetal bovine serum was poured into a centrifuge tube. Both femora were removed and the bones freed of muscle tissue. The proximal ends of the femora were opened and the bone marrow flushed into the centrifuge tube. A suspension was formed. The mixture was then centrifuged for 5 minutes at 1200 rpm and almost all the supernatant discarded. One drop of the thoroughly mixed sediment was smeared on a cleaned slide, identified by project code and animal number and air-dried for about 24 hours.
- Evaluation criteria:
- 1000 polychromatic erythrocytes were counted for each animal. The number of cells with micronuclei was recorded. As a control measure 1000 mature erythrocytes were also counted and examined for micronuclei. In addition, the ratio of polychromatic to normochromatic erythrocytes was determined. The number of polychroma tic erythrocytes with micronucl i occurring in the 1000 polychromatic erythrocytes counted, and the number of normocytes with micronuclei occurring in the 1000 normocytes counted, were evaluated stastistically; comparison of dose groups with the simultaneous control group was performed according to Wilcoxon (paired, one·sided, increase).
The results of the treatment groups (test substance) in the micronucleus test at each dose and killing time were compared with corresponding control values. The ratio of polychromatic to normochromatic erythrocytes was also evaluated statistically by the method of Wilcoxon (paired. two sided). All statistical results are based on a 95 % level of significance. Actual data were also compared with historical controls. - Statistics:
- Wilcoxon (paired, one·sided, increase). All statistical results are based on a 95 % level of significance.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The results indicate that, under the conditions of the present study, Acetoacetamid is not mutagenic in the micronucleus test. - Executive summary:
Acetoacetamid was tested in the micronucleus test. The test compound was administered orally by gavage to male and female mice. The following doses were tested: 500, 2750 and 5000 mg Acetocetamid per kg body weight.
5000 mg per kg body weight was chosen since a preliminary study had shown it to be the maximum applicable dose. The animals were treated once with the test compound and were killed 24, 48 or 72 hours after administration.
Endoxan(R) was used as positiv control and was administered orally at a dose of 50 mg per kg body weight.
The incidence of micronucleated polychromatic erythrocytes of the animals treated with Acetoacetamid was within the normal range of the negative control. The number of normochromatic erythrocytes containing micronucuei was not increased. The ratio of polychromatic/normochromatic erythrocytes in both male and female animals remained unaffected by the treatment with Acetoacetamid and was statistically not different from the control values.
Endoxan(R) induced in both males and females a marked statistically significant increase in the number of polychromatic cells with micronuclei, indicating the sensitivity of the system. The ratio of polychromatic erythrocytes to normocytes was not changed to a significant extend.
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