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EC number: 264-713-0 | CAS number: 64164-17-6
- 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
In an OECD guideline study, the acute oral LD50 value for diammonium sodium hexakis(nitrito-N)rhodate was determined to exceed 2000 mg/kg bw following gavage administration in female rats.
No relevant acute dermal or inhalation toxicity data were identified.
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:
- 15 April - 12 May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Conducted according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CRL:(WI) rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation:8-11 weeks
- Weight at study initiation: 202-231 g
- Fasting period before study: overnight prior to treatment
- Housing: Individual caging in Type II polypropylene/polycarbonate cages with Lignocel Bedding for Laboratory Animals and deep wood sawdust bedding to allow digging and other normal rodent activities.
- Diet (e.g. ad libitum): ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany, ad libitum
- Water (e.g. ad libitum): tap water from the municipal supply, from 500 ml bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 – 23.3
- Humidity (%): 37-60
- Air changes (per hr): 15 – 20
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 1%
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: various
- Amount of vehicle (if gavage): 1.0-1.2 ml/animal
- Justification for choice of vehicle: based on trial formulations with the test item
- Lot/batch no. (if required): 1D30012N13
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 1.2 ml/animal
- Rationale for the selection of the starting dose: The doses were selected from the sequence 1.75, 5.5, 17.5, 55, 175, 550, 2000 mg/kg bw. A starting dose of 175 mg/kg bw was selected after discussions between the Study Director and the Sponsor. - Doses:
- 175, 550, 2000 mg/kg bw
- No. of animals per sex per dose:
- 1 (in lower two dose groups); 3 (in highest dose group)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observation after dosing at 30 minutes, then at 1, 2, 3, 4, and 6 hours, then once each day for 14 days thereafter. Weighing one day before and on the day of treatment (day 0), and on days 7 and 14 after treatment.
- Necropsy of survivors performed: yes
- Observations: these included the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsies: macroscopic examination of the external appearance and of the tissues and organs of the cranial, thoracic and abdominal cavities. - Statistics:
- The Acute Oral Toxicity (OECD Test Guidelines 425) Statistical Programme (AOT 425 Stat Pgm) was used to evaluate data.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: CL not applicable
- Mortality:
- None
- Clinical signs:
- None
- Body weight:
- No indication of a treatment-related effect for body weight or body weight gain
- Gross pathology:
- No macroscopic observations
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an OECD guideline study, the acute oral LD50 value for diammonium sodium hexakis(nitrito-N)rhodate was determined to exceed 2000 mg/kg bw following gavage administration in female rats.
- Executive summary:
The acute oral toxicity of diammonium sodium hexakis(nitrito-N)rhodate was assessed in female rats, in a study carried out in accordance with OECD guideline 425 and to GLP. Animals were treated by gavage with the test material (in 1% methyl cellulose) at doses of 175 (1 animal), 550 (1 animal) or 2000 (3 animals) mg/kg body weight. Macroscopic examination was conducted on surviving animals.
No mortality, clinical signs or effects on body weight/growth were apparent during the 14-day post-dose observation period, and there were no notable external or internal macroscopic findings upon necropsy. The study investigators concluded that the acute oral median lethal dose (LD50) of diammonium sodium hexakis(nitrito-N)rhodate was greater than 2000 mg/kg bw in female rats.
Based on the results of this study, diammonium sodium hexakis(nitrito-N)rhodate does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Overall, good-quality database which meets REACH Standard Information Requirements
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No relevant acute toxicity human data were identified.
The acute oral toxicity of diammonium sodium hexakis(nitrito-N)rhodate was assessed in female rats, in a study carried out in accordance with OECD Test Guideline 425 and to GLP. Animals were treated by gavage with the test material (in 1% methyl cellulose) at doses of 175 (1 animal), 550 (1 animal) or 2000 (3 animals) mg/kg body weight. Macroscopic examination was conducted on surviving animals. No mortality, clinical signs or effects on body weight/growth were apparent during the 14-day post-dose observation period, and there were no notable external or internal macroscopic findings upon necropsy. The study investigators concluded that the acute oral median lethal dose (LD50) of diammonium sodium hexakis(nitrito-N)rhodate was greater than 2000 mg/kg bw in female rats (Matting, 2014).
No acute inhalation toxicity data were identified. However, the compound is not expected to reach the lungs in appreciable quantities (based on respiratory tract deposition modelling data). Thus, inhalation will not be a significant route of exposure. Similarly, no acute dermal toxicity data were identified. However, this study does not need to be conducted as the substance does not meet the criteria for classification for acute toxicity by the oral route.
Justification for classification or non-classification
Based on the results of the available and reliable acute oral rat study, diammonium sodium hexakis(nitrito-N)rhodate does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).
No evidence of specific target organ toxicity was noted. As such, classification for STOT-SE is not considered appropriate.
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