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EC number: 221-576-1 | CAS number: 3148-73-0
- 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:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: - meets generally accepted scientific principles - Documentation insufficient for thorough assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Mutagenicity and carcinogenicity of mono- and diacetyl hydrazine.
- Author:
- Bhide SV, Bhalerao EB, Sarode AV, Maru GB.
- Year:
- 1 984
- Bibliographic source:
- Cancer Lett. 1984 Jun;23(2):235-40.
- Reference Type:
- publication
- Title:
- The in vivo micronucleus assay in mammalian bone marrow and peripheral blood. A report of the U.S. Environmental Protection Agency Gene-Tox Program.
- Author:
- Mavournin KH, Blakey DH, Cimino MC, Salamone MF, Heddle JA.
- Year:
- 1 990
- Bibliographic source:
- Mutat Res. 1990 Jul;239(1):29-80.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- : 4 animals per dose, 2 treatments at an interval of 24 h, single sampling 6 h after last treatment.
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- N,N'-diacetylhydrazine
- EC Number:
- 221-576-1
- EC Name:
- N,N'-diacetylhydrazine
- Cas Number:
- 3148-73-0
- Molecular formula:
- C4H8N2O2
- IUPAC Name:
- N'-acetylacetohydrazide
- Details on test material:
- - Name of test material (as cited in study report): diacetyl hydrazine (DAH)
- Physical state:
• diacetylhydrazine: not reported
- Analytical purity:
• diacetylhydrazine: not reported
- Impurities (identity and concentrations):
• diacetylhydrazine: not reported
- Composition of test material, percentage of components:
• diacetylhydrazine: not reported
- Provider: Ega Chemie, Germany (nowadays Sigma-Aldrich)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 20 - 30 g
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: none
- Justification for choice of solvent/vehicle: N/A - Details on exposure:
- APPLICATION
- ip injection of pure diacetylhydrazine: at 2400 mg/kg bw/d - Duration of treatment / exposure:
- - twice, at an interval of 24 h
- Frequency of treatment:
- - twice, at an interval of 24 h
- Post exposure period:
- not applicable animals sacrificed 6 h after last dosing
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2400 mg/kg bw/d of diacetylhydrazine
Basis:
other: actual injected
- No. of animals per sex per dose:
- 4 males per dose
- Control animals:
- other: yes, concurrent treatment with 0.2 mg water/animal
- Positive control(s):
- Monoacetyl hydrazine was tested in parallel and showed positive results. It can be regarded as a positive control.
Examinations
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
- Based on LD50 values of 3000 mg diacetyl hydrazine/kg bw in mice
DETAILS OF SLIDE PREPARATION:
- bone marrow preparations
- stained in May-Grunwald Giemsa
- mounted in Euparol
METHOD OF ANALYSIS:
- 4000 polychromatic and normochromatic erythrocytes scored per animal
OTHER: - Evaluation criteria:
- not reported
- Statistics:
- Results are mean ± S.E. of 4 animals in each group.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Remarks:
- for diacetylhydrazine
- Toxicity:
- no effects
- Remarks:
- , based on an unaffected ratio of polychromatic cells/normochromatic cells as compared to negative control
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- no range finding study reported
RESULTS OF DEFINITIVE STUDY
- acetylhydrazine: significant increase in the frequency of micronuclei in the polychromatic erythrocyte.
- diacetylhydrazine: no significant increase in the frequency of micronuclei in the polychromatic erythrocyte.
Any other information on results incl. tables
- Table 1: mutagenicity of DAH using the micronucleus test
No. |
Compound |
Dose/ animal (mg) |
% Polychromatic erythrocytes with micronucleus |
P/N ratio (a) |
1 |
Distilled water |
0.2 |
0.25 ± 0.05 |
1.0 |
2 |
DAH |
48 |
0.36 ± 0.03 |
1.1 |
Results are expressed as mean ± S.E. of 4 animals in each group.
(a) P/N ratio, ratio of polychromatic to normochromatic cells.
*Statistically significant when compared with controls, P < 0.05.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
Diacetylhydrazine was tested for it's potential to cause chromosome abberations in an in vivo micronucleus test in Swiss mice 2400 mg/kg bw ip injected twice, conducted comparable to OECD 474. No adverse effects were seen for diacetylhydrazine at the tested dose. Accordingly diacetylhydrazine (DAH) is deemed negative for in vivo chromosome abberation in this test system.
Though the details reported are too limited for a solid assessment, the results are deemed relevant and sufficient as supporting information. - Executive summary:
In the study Bhide (1984) diacetylhydrazine were tested for their potential to cause chromosome abberations in an in vivo micronucleus test in Swiss mice at 2400 mg/kg bw ip injected twice, conducted comparable to OECD 474.
4 male Swiss mice per dose were used and the animal were treated twice at an interval of 24 h. Sampling was conducted once, 6 h after the last treatment. Bone marrow preparations were made, stained in May-Grunwald Giemsa and mounted in Euparol. 4000 polychromatic and normochromatic erythrocytes were scored per animal.
No adverse effects were seen for diacetylhydrazine at the tested dose. Accordingly diacetylhydrazine (DAH) is deemed negative for in vivo chromosome abberation in this test system.
Though the details reported are too limited for a solid assessment, the results are deemed relevant and sufficient as supporting information.
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