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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- from 2004-03-09 to 2004-03-17
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is a screening study which did not formally follow a guideline method, and was not formally performed under audited GLP, however, the laboratory facilities were operated according to GLP. Compared to a similar guideline method, a reduced number of animals were tested, a reduced observation period used, and the purity of the test material was not reported. The documentation in the report was very limited. Although the results are considered valid, the screening study itself cannot be considered formally reliable due to the lack of formal guideline, quality assurance, and very limited documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Principles of method if other than guideline:
- A standard test method from the performing test facility was followed. The test was comparable to OECD TG 401. However, only 4 animals were tested and the observation period was only 9 days.
- GLP compliance:
- no
- Remarks:
- This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.
- Test type:
- standard acute method
- Limit test:
- yes
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
- Test material form:
- not specified
- Details on test material:
- Test material characterisation data are the responsibility of the Sponsor.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No details on test animals and environmental conditions are reported.
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Remarks:
- The test material was administered orally as a solution in distilled water.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: not reported
MAXIMUM DOSE VOLUME APPLIED: not reported
DOSAGE PREPARATION (if unusual): not reported - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2 males, 2 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 8 days
- Frequency of observations and weighing:
Weighing: day of dosing, day 1 and day 8
Clinical observations and mortality: 0.5, 1, 2, 4 hours after initiation of exposure, 1, 2, 3, 4, 5, 6, 7, 8 days after initiation of exposure
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortality, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were detected.
Any other information on results incl. tables
Individual Body Weight and Weekly Bodyweight Changes
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) Day -1 to Day 8 |
||
Day -1 |
Day of Dosing |
Day 8 |
|||
2000 |
1-0 Male |
307 |
290 |
360 |
53 |
1-1 Male |
304 |
300 |
382 |
78 |
|
2-0 Female |
203 |
190 |
234 |
31 |
|
2-1 Female |
196 |
182 |
208 |
12 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material, in the Sprague-Dawley CD strain rat, was estimated as being greater than 2000 mg/kg bodyweight. Although the result is considered to be valid, due to the lack of formal guideline and quality assurance, and very limited documentation, it must be regarded as not being reliable.
- Executive summary:
The study was performed to estimate the toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat.
A group of four fasted animals (two males and two females) was treated with the test material at a dose level of 2000 mg/kg bodyweight. The test material was administered orally as a solution in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
There were no deaths and no signs of systemic toxicity. All animals gained weight during the study and no abnormalities were detected at necropsy. The acute oral median lethal dose (LD50) of the test material, in the Sprague-Dawley CD strain rat, was estimated as being greater than 2000 mg/kg bodyweight.
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