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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
Carcinogenicity
Administrative data
Description of key information
- Oral: negative, 2 year carcinogenicity bioassay with mice, no guideline followed, Bhide 1984
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- 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
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Swiss mice randomly distributed to groups so as to have the same number of males and females in each group (total 30 or 40).
- animals applied with DAH (1.1 mg/day per mouse) or distilled water 5 times a week by stomach tube
- Experiment 1: treatment until death or until sacrifice
- Experiment 2: 1.1 mg/day per mouse of DAH applied via gavage 5 times a week for 8 months
- Final examination: lungs examined macroscopically and fixed in 10% formalin, processed by routine histological process and sections (6 µm), stained with hematoxylin and eosin
- Statistical analysis performed by the chi-square-test. - GLP compliance:
- no
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Diacetylhydrazine dosed undiluted
VEHICLE
- n/a - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Experiment 1: 16 - 22 months
Experiment 2: 8 months - Frequency of treatment:
- 5 d/week
- Post exposure period:
- none
- Remarks:
- Doses / Concentrations:
Experiment 1: 1.1 mg/d/animal
Basis:
actual ingested - Remarks:
- Doses / Concentrations:
Experiment 2: 1.1 mg/d/animal
Basis:
actual ingested - No. of animals per sex per dose:
- 15 - 20 per sex and dose
- Control animals:
- other: yes, concurrent treated with distilled water (unknown amount)
- Details on study design:
- - Dose selection rationale: no data
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: n/a
- Post-exposure recovery period in satellite groups: n/a
- Section schedule rationale (if not random): no data - Positive control:
- no
- Observations and examinations performed and frequency:
- - Experiment 2: animals "observed"
- Sacrifice and pathology:
- - Final examination: lungs examined macroscopically and fixed in 10% formalin, processed by routine histological process and sections (6 µm), stained with hematoxylin and eosin
- Statistics:
- - Statistical analysis performed by the chi-square-test.
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- increased mortality at 0.8 mg/animal/d
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- increased mortality at 0.8 mg/animal/d
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- raised lung tumor incidence in all acetyl hydrazine treatment groups, no statistically significant increase in any diacetylhydrazine treatment group
- Details on results:
- HISTOPATHOLOGY: NEOPLASTIC (if applicable)
- general:
• no significant difference in the tumor incidences between sexes in any dose group, therefore results pooled for sexes
• lung tumor types: adenoma and papillary adenocarcinoma, some of which were transplantable
• incidence of hemangiosarcomas not statistically different between control groups and treatment groups
• Experiment 1:
0.8 mg/animal/d: decreased tumor incidence of 0 % in survivors (20 survivors) as compared 13 % in controls
1.1 mg/animal/d: only 10 males survived, of these 3 developed lung tumors resulting in a tumor incidence of 30 % as compared 13 % in controls, this rise is not statistically significant.
• Experiment 2:
1.1 mg/animal/d for 8 months: tumor incidence of 10 % (in 19 survivors) - Relevance of carcinogenic effects / potential:
- - The development of lung tumors after repeated oral gavage is indicative for a specific, systemic effect.
- Nevertheless the delivered information is so limited that the relevance of the reported effects cannot be thoroughly assessed.
- Obviously only surviving animals were included in the analysis of tumour incidents as in any of the dose groups the total number of animals adds up to 30 or 40 as reported to be initially entered into the study. Therefore the reported incidences have to be analysed with caution. - Dose descriptor:
- NOAEL
- Effect level:
- >= 1.1 other: mg/animal/d
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- other: Effect type: carcinogenicity
- Conclusions:
- Diacetylhydrazine (DAH) were tested for their potential to increase the incidence of lung tumors in Swiss mice of both sexes after repeated oral treatment at 0.8 and 1.1 mg/animal/d (oral gavage, 5 d/week, treatment period 2 years and 8 months).
Diacetylhydrazine treatment did not lead to a statistically significant increase in the tumor incidence in any of the treatment groups as compared to the negative control group. - Executive summary:
In the study Bhide (1984) Diacetylhydrazine (DAH) were tested for their potential to increase the incidence of lung tumors in Swiss mice of both sexes after repeated oral treatment at 0.8 and 1.1 mg/animal/d (oral gavage, 5 d/week, treatment period 2 years (Experiment 1) and 8 months (Experiment 2, high dose only)).
Generally no significant difference was seen in the tumor incidences between sexes in any dose group, therefore results were pooled for sexes. Lung tumor types identified were adenoma and papillary adenocarcinoma, some of which were transplantable. The incidence of hemangiosarcomas was not statistically different between control groups and treatment groups and therefore is not regarded further.
For diacetylhydrazinedecreased tumor incidence of 0 % in survivors (20 survivors) was found as compared 13 % in controls in the 0.8 mg/animal/d groups of experiment 1. In the 1.1 mg/animal/d groups only 10 males survived until week 16 - 22. Of these 3 developed lung tumors resulting in a tumor incidence of 30 % as compared 13 % in controls. This rise is not statistically significant.
In experiment 2 the tumor incidence was 10 % (2 of 19 survivors) after treatment with 1.1 mg diacetylhydrazine/animal/d for 8 months.
Diacetylhydrazine treatment did not lead to a statistically significant increase in the tumor incidence in any of the treatment groups as compared to the negative control group.
Relevance of the presented results:
- The development of lung tumors after repeated oral gavage is indicative for a specific, systemic effect.
- Nevertheless the delivered information is so limited that the relevance of the reported effects cannot be thoroughly assessed.
- Obviously only surviving animals were included in the analysis of tumour incidents as in any of the dose groups the total number of animals adds up to 30 or 40 as reported to be initially entered into the study. Therefore the reported incidences have to be analysed with caution.
Reference
- Table 1: Tumor incidence in Swiss mice treated with DAH
Group |
Male |
Female |
Combined/ tumor incidence (%) |
Distilled water control |
2/18 |
3/20 |
5/38 (13) |
0.8 mg/day per mouse continuous |
0/10 |
0/10 |
0/21 (0) |
1.1 mg/day per mouse continuous |
3/10 |
- |
3/10 (30) |
1.1 mg/day per mouse for 8 months only |
2/11 |
0/8 |
2/19 (10) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- Only one study available from the literature, which generally meets accepted scientific principles. However, documentation insufficient for thorough assessment.
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test material showed no potential for carcinogenicity in a mouse 2 year bioassay. Accordingly, the substance does not meet the criteria for classification according to commission Directive 2001/59/EC, Annex VI.
The test material showed no potential for carcinogenicity in a mouse 2 year bioassay. Accordingly, the substance does not meet the criteria for classification according to commission Regulation 1272/2008, Annex I, Part 3, 3.6.2
Additional information
Diacetylhydrazine was tested for its potential to increase the incidence of lung tumors in Swiss mice of both sexes after repeated oral treatment at 0.8 and 1.1 mg/animal/d (oral gavage, 5 d/week, treatment period 2 years and 8 months) (Bhide 1984). Treatment with the test material did not lead to a statistically significant increase in the tumor incidence in any of the treatment groups as compared to the negative control group.
Justification for selection of carcinogenicity via oral route endpoint:
Only one study available.
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