Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
The acute oral LD50 to rats of adipic acid dihydrazide is greater than 2000 mg/kg bodyweight.
The acute inhalation LC50,4h to rats of adipic acid dihydrazide is greater than 5.3 mg/L.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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.
- 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
- 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.
- 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.
- 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.
- 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).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented, scientifically acceptable study report.
- Principles of method if other than guideline:
- According to BASF-internal standard.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean body weight at the start of the study: male animals 266 g, female animals 183 gAge at the beginning of the study: 8 weeksThe animals received Kilba A 343 laboratory diet for rats/mice. 10 mm pellets, Klingentalmühle AG, 4303 Kaiseraugst. Switzerland, and drinking water ad libitum during the observation period.The animals were accommodated in fully air-conditioned rooms in which central air-conditioning guaranteed a range of temperature of 20 – 24 °C and a range of relative humidity of 30 - 70%.The rats were housed in groups of five in D III Wire mesh cages, without bedding and with a light/dark rhythm of 12 hours.
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged
- Details on inhalation exposure:
- INA 20 head/nose inhalation system (glass/steel construction, BASF Aktiengesellschaft, V = 55 L), the animals sit in tubes and their snouts project into the inhalation chamber.A dust/air mixture was generated by means of a vibratory metering device (BASF).The substance to be tested was transformed into a dust aerosol by means of a dust generator, and was passed into the inhalation system.An automatic vibrator was used to generate dust. The concentration was adjusted by varying the apertural width and the amplitude of oscillation of the metering beaker.The following flows were adjusted: 1500 L/h of compressed air through the injector and 1500 L/h of conditioned air as dilution air. The supply air was conditioned via a central air-conditioning unit so that there was a temperature of between 19 and 25 °C inside the exposure equipment.The setting of the exhaust air system was 10% lower than that of the supply air system (excess pressure). This ensured that the mixture of the test substance and air was not diluted by laboratory air to the breathing zones of the animals. In order to analyse the particle size, one sample was collected from each test group no earlier than 30 minutes following the start of the study. Prior to sample collection, the impactor was provided with glass fiber collecting disks and a residual particles filter. It was connected to the pump and the test equipment and a sample (9 L) was collectedThe impactor was disassembled, the collecting disks and the residual particles filter were weighed, the samples obtained were analysed gravimetrically. The contents of the preimpactor were also determined gravimetrically.Test atmosphereMMAD (Mass median aerodynamic diameter) / GSD (geometric st. dev .): 3.90 µm / 2.78 µm.The results from particle size analyses demonstrate a fine dust proportion of 85.4 %.
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric determination of the concentration
- Duration of exposure:
- 4 h
- Concentrations:
- 5.3 mg/L
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: The animals surviving the exposure period were observed for 14 days.- Frequency of observations and weighting: The animals' body weights were checked before the start of the study, after 7 days and at the end of the observation period, and were collated in a diagram. The animals were checked for clinical signs on each working day. The lethality was checked daily.- Necropsy of survivors: Subsequent to the 14-day observation period, the animals were sacrificed by means of C02 and subjected to a gross-pathological examination
- Statistics:
- Yes.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.3 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- None.
- Clinical signs:
- other: During exposure: attempts to escape at study start. After exposure: none.
- Body weight:
- No impairment compared with the control group.
- Gross pathology:
- Sacrificed animals: nothing abnormal detected.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The LC50,4h of adipic acid dihydrazide is >5.3 mg/L.
- Executive summary:
Rats were exposed to adipic acid dihydrazide as a dust in a head/nose inhalation system to a concentration of 5.3 mg/L. The animals were checked for clinical signs for 14 days. Subsequent to the 14-day observation period, the animals were subjected to a gross-pathological examination.
No mortality and no relevant clinical signs or lesions at post mortem examination were detected. The LC50,4h >5.3 mg/L.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 300 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A key study.
Justification for selection of acute toxicity – inhalation endpoint
A key study.
Justification for classification or non-classification
No indications were obtained to justify a classification.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.