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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 March - 2 April 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Conducted according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- Minor humidity deviations were expected to have no impact on the study outcome
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- Minor humidity deviations were expected to have no impact on the study outcom
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Remarks:
- Minor humidity deviations were expected to have no impact on the study outcom
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diammonium sodium hexakis(nitrito-N)rhodate
- EC Number:
- 264-713-0
- EC Name:
- Diammonium sodium hexakis(nitrito-N)rhodate
- Cas Number:
- 64164-17-6
- Molecular formula:
- H4N.1/2N6O12Rh.1/2Na
- IUPAC Name:
- Diammonium sodium hexakis(nitro-N)rhodate
- Details on test material:
- - Name of test material (as cited in study report): Diammonium sodium hexakis(nitrito-N)rhodate
- Substance type: Technical product
- Physical state: Solid (yellow/green powder)
- Analytical purity: 100% (rhodium content 15.302%)
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: An analysis report constitutes Appendix 4 of full study report and documents trace amounts of some elements
- Purity test date: 07 October 2011
- Lot/batch No.:RHL 586
- Expiration date of the lot/batch: 01 October 2016
- Stability under test conditions: no data
- Storage condition of test material: Controlled Room Temperature (15-25°C, below 70 RH%)
- pH of test material: 4.9
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: S&K-LAP Kft., 2173 Kartal, Császár road 135, Hungary
- Age at study initiation: ~12 weeks
- Body weight range at the beginning of the in-life phase: 3167 – 3204 g
- Body weight range at the end of the in-life phase: 3402 – 3416 g
- Housing: individually in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages
- Diet (e.g. ad libitum): Purina and UNI diet (Lot number: 00701211 and 0030 03 12) for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum.
- Water (e.g. ad libitum): municipal tap water, as for human consumption, ad libitum
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 24 – 52 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- Following instillation into the conjunctival sac of one eye, the eyelids were held closed for several seconds. No rinsing was performed.
- Observation period (in vivo):
- 1 week (The eyes were examined at 1, 24, 48 and 72 hours, and 1 week after treatment).
- Number of animals or in vitro replicates:
- 3 (males)
- Details on study design:
- Rinsing of treated eyes was not performed.
The other eye remained untreated and was used for control purposes.
The eyes were examined at 1, 24, 48 and 72 hours, and 1 week after treatment. The nature, severity and duration of all lesions observed were described.
SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002) shown in Appendix 1 of the attached study report.
TOOL USED TO ASSESS SCORE: none reported; presumably subjective observation by an experienced evaluator
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Remarks:
- Conjunctival chemosis
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: Mean of 24, 48 and 72-hour timepoints
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: Slight chemosis was seen in one animal at one hour; this had resolved by 24 hours
- Irritation parameter:
- other: Conjunctival discharge
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72-hour timepoints
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: Considerable discharge was seen in one animal, and slight discharge in two animals, at 1 hour; this had resolved to normal by 24 hours in all cases
- Irritation parameter:
- other: Conjunctival redness
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72-hour timepoints
- Score:
- 0.56
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 1 week
- Remarks on result:
- other: One animal was symptom-free by 24 hours, one by 72 hours and one by 1 week
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity, degree of density
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72-hour timepoints
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: No corneal opacity was seen in any animal at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72-hour timepoints
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: The iris was not affected in any animal at any time point
- Irritant / corrosive response data:
- Initial Pain Reaction (IPR) (score 2) was observed in all animals.
One hour after the application, conjunctival redness (score 1) and conjunctival discharge (score 1 or score 3) were seen in all animals. Conjunctival chemosis (score 1) was observed in one rabbit.
At 24 and 48 hours after treatment, conjunctival redness (score 1) was observed in two animals.
At 72 hours after treatment, conjunctival redness (score 1) was observed in one animal.
At 1 week after treatment no signs of eye irritation or other clinical signs were observed.
As there were no clinical signs observed, the study was terminated after the 1 week observation.
During the study, the control eye of each animal was symptom-free.
The individual mean scores for each animal (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
chemosis : 0.00, 0.00, 0.00
discharge : 0.00, 0.00, 0.00
redness : 1.00, 0.67, 0.00
cornea opacity : 0.00, 0.00, 0.00
iris : 0.00, 0.00, 0.00 - Other effects:
- There were no clinical signs observed that could be related to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an OECD Test Guideline 405 study, to GLP, diammonium sodium hexakis(nitrito-N)rhodate (0.1 g) caused some conjunctival effects in the eyes of three male rabbits within 1 hr of instillation, but these effects were fully reversible within 1 week.
- Executive summary:
In an in vivo eye irritation study carried out in accordance with OECD Test Guideline 405, and to GLP, 0.1 g of powdered diammonium sodium hexakis(nitrito-N)rhodate was instilled into the conjunctival sac of one eye of 3 male New Zealand White rabbits. Following instillation the eyelids were held closed for several seconds; no rinsing was performed. The other eye remained untreated and was used for control purposes. The eyes were examined at 1, 24, 48, 72 hours, as well as 1 week after treatment, and scored according to the Draize system.
Mild conjunctival effects (including redness, chemosis and discharge) occurred within 1 hour of application. These were either reduced or absent at 24 hours and were fully reversible within 1 week.
Based on the results of this study, diammonium sodium hexakis(nitrito-N)rhodate does not require classification for eye irritation, according to EU CLP criteria (EC 1272/2008).
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