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EC number: 213-999-5 | CAS number: 1071-93-8
- 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:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- adipic dihydrazide
- IUPAC Name:
- adipic dihydrazide
- Reference substance name:
- ADH
- IUPAC Name:
- ADH
- Details on test material:
- Names: Adipic dihydrazide; ADHAppearance: White crystalline powderStorage conditions: Room temperature in the darkLot number: 0E96Purity: > 99%Expiry date: 25 May 2012Date received: 04 October 2010
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Healthy nulliparous and non-pregnant female CD (Crl:CD ‘SD’) rats were obtained from Charles River (UK) Ltd.The animals were allocated without conscious bias to cages within the treatment groups. They were housed in groups of three rats of the same sex, in solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved wood flake bedding. Cages, food hoppers, water bottles and bedding were changed at appropriate intervals.Each animal was assigned an alpha-numeric code and identified uniquely within the study by tail marking. Each cage label was colour-coded and was identified uniquely with the study number, dose level and animal mark.The animals were allowed to acclimatise to the conditions described below for at least 5 days before treatment. For those animals selected for this study, their bodyweights were in the range 197 to 218 g and they were approximately eight to twelve weeks of age prior to dosing (Day 1).Animals were housed inside a barriered rodent facility. The temperature and relative humidity controls were set to maintain the range of 19 to 23°C and 40 to 70% respectively. Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per24 hours. The animals were allowed free access to a standard rodent diet, except for overnight prior to and approximately four hours after dosing.Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes.During the acclimatisation period, each cage of animals was provided with a soft white untreated chew block and a plastic shelter for environmental enrichment. The wood blocks were removed from the cage of animals for the same period as the food on the day prior todosing.Each batch of diet was analysed routinely by the supplier for various nutritional components and chemical and microbiological contaminants. Supplier’s analytical certificates were scrutinised and approved before any batch of diet was released for use. The quality of thewater supply is governed by regulations published by the Department for Environment, Foodand Rural Affairs.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 % methyl cellulose
- Details on oral exposure:
- The test substance was formulated at a concentration of 200 mg/mL in the vehicle and administered at a volume of 10 mL/kg bodyweight.The test substance formulations were prepared on the day of dosing.
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 + 3 females.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?)- Frequency of observations: Cages of rats were checked at least twice daily for any mortalities. - Frequency of weighing: The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weeklybodyweight changes and group mean bodyweights were calculated.- Necropsy of survivors performed: yes/no- Frequency of clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The nature and severity, where appropriate, of the clinical signs and the time were recorded at each observation.All animals were observed for 14 days after dosing.
- Statistics:
- Not applicable.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths.
- Clinical signs:
- other: There were no clinical signs of reaction to treatment throughout the study.
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at studytermination on Day 15.
- Other findings:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of adipic acid dihydrazide is greater than 2000 mg/kg bodyweight.Adipic acid dihydrazide is included in Category 5 or unclassified, according to the Globally Harmonised System (GHS).
- Executive summary:
The study was performed to assess the acute oral toxicity of adipic acid dihydrazide to rats using the Acute Toxic Class method, according to EU- and OECD-methods.
The acute median lethal oral dose (LD50) to rats of adipic acid dihydrazide is greater than 2000 mg/kg bodyweight. Adipic acid dihydrazide is included in Category 5 or unclassified, according to the Globally Harmonised System (GHS).
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