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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In Vitro
3 Ames tests are available one of which (Callander, 2004) was conducted rather closely to OECD TG 471. Although the result is considered to be valid, due to the lack of formal guideline and quality assurance, and very limited documentation, it should be regarded as not being reliable. This test gave a negative result both with and without activation using Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strains WP2 (pKM101) and WP2 uvrA (pKM101), applying the standard plate-incorporation assay protocol. This negative result is corroborated by the results from the independently conducted literature studies from Bhide (1984) (results also mentioned in Menon (1981), using TA 1535, TA 100, TA 98, TA 92 following in general OECD TG 471) and Tosk (1979) (using TA1535, TA100 and TA1530 following in general OECD TG 471).
The available studies are considered to be relevant and adequate for classification purposes. As a result, the data requirements for Regulation (EC) No. 1907/2006, Annex VII, 8.4.1, are considered to be met on the basis of the weight-of-evidence, in accordance with Annex XI, 1.2.
In Vivo
One relevant in vivo study was available addressing chromosome damage. In the study (Bhide, 1984) diacetylhydrazine was tested for its potential to cause chromosome damage in an in vivo micronucleus test in Swiss mice at 2400 mg/kg bw ip injected twice and conducted comparable to OECD 474. No adverse effects were seen at the tested dose, and the substance is deemed negative for in vivo chromosome damage in this test system. This study result was also cited in Mavourinin (1990).
Diacetylhydrazine was also tested for its potential to inhibit testicular DNA synthesis in the mouse in male Swiss mice after single ip injection of 3000 mg/kg bw. The treatment did not lead to an adverse effect as compared to the negative control. Accordingly, the substance is deemed negative for inhibition of testicular DNA synthesis in the mouse in this test system.
The studies are considered to be relevant, but not reliable because they were not performed according to a recognised guideline, nor under GLP, or with sufficient documentation.
Justification for selection of genetic toxicity endpoint
The endpoint is met on the basis of the weight of evidence.
Short description of key information:
- gene mutation in vitro: negative, Ames test, comparable OECD 471, Callander 2004, Menon 1981 & Bhide 1984, Tosk 1979
- chromosome damage in vivo: negative, comparable OECD 474, Bhide 1984 & and Mavourinin 1990
- murine testicular DNA synthesis inhibition: negative, no guideline, Menon 1981 & Bhide 1984
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The test item showed no genetic toxicity in any of the analysed endpoints bacterial gene mutation, chromosome damage in vivo and inhibit testicular DNA synthesis in the mouse. Other endpoints on genetic toxicity were not tested. Accordingly, the substance does not meet the criteria for classification according to commission Directive 2001/59/EC.
The test item showed no genetic toxicity in any of the analysed endpoints bacterial gene mutation, chromosome damage in vivo and inhibit testicular DNA synthesis in the mouse. Other endpoints on genetic toxicity were not tested. Accordingly, the substance does not meet the criteria for classification according to commission Regulation 1272/2008, Annex I, Part 3, 3.5
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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