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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
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- Nanomaterial pour density
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- 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
Diammonium sodium hexakis(nitrito-N)rhodate was non-sensitising in a mouse local lymph node assay (LLNA), conducted according to OECD Test Guideline 429 and to GLP (Henzell, 2013).
No respiratory tract sensitisation data are available.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 August - 18 September 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Guideline study performed largely to GLP (except that the stability of the test item was determined in a separate analytical study, and no analysis was conducted to determine the homogeneity or concentration of the test item). Minor deviations (humidity outside 30-70% range) not expected to affect study validity.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- on occasions, relative humidity was outside the target range of 30-70%. This was not considered to affect study integrity
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Except that the stability of the test item was determined in a separate analytical study, and no analysis was conducted to determine the homogeneity or concentration of the test item.
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaOlaHsd)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): target: 19-25 (no data on actual values, but presumably not outside this range)
- Humidity (%): target: 30-70 (no data on actual values, but occasional deviations outside this range were noted, and were not considered to affect study integrity)
- Air changes (per hr): ~15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data - Vehicle:
- propylene glycol
- Concentration:
- Range-finding study: 25% (w/w)
Main study: 0, 5, 10 or 25% - No. of animals per dose:
- Range-finding study: 1
Main study: 5 - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: solubility in various common vehicles assessed to find the vehicle giving the highest concentration suitable for dosing
- Irritation: yes. Range-finding mouse observed twice daily on days 1, 2 and 3, and once daily on days 4, 5 and 6, with erythema scored from 0-4.
- Lymph node proliferation response: not performed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: local lymph node assay
- Criteria used to consider a positive response: the proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per animal and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index). The test item was regarded as a sensitiser if at least one concentration resulted in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation was classified as a "non sensitiser."
TREATMENT PREPARATION AND ADMINISTRATION: the test item was freshly prepared as a suspension in propylene glycol. The test item was formulated within two hours of being applied to the test system. 25 µl was applied topically to the ears of mice on days 1, 2 and 3 in both the range-finding and the main study. - Positive control substance(s):
- other: phenylacetaldehyde (>90% purity) at 2.5% (v/v) in propylene glycol
- Statistics:
- Data were processed to give group mean values for disintegrations per minute and standard deviations where appropriate. Individual and group mean disintegrations per minute values were assessed for dose response relationships by analysis of homogeneity of variance followed by one way analysis of variance (ANOVA). In the event of a significant result from the ANOVA, pairwise comparisons were performed between control and treated groups. For homogenous datasets, Dunnett’s Multiple Comparison test was used, and for non homogenous datasets, Dunnett’s T3 Multiple Comparison Method was used.
- Parameter:
- SI
- Remarks on result:
- other: See Table 1 in "any other information on results incl. tables".
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See Table 1 in "any other information on results incl. tables".
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Diammonium sodium hexakis(nitrito-N)rhodate was non-sensitising in a mouse LLNA, conducted according to OECD guideline 429.
- Executive summary:
The skin sensitising potential of diammonium sodium hexakis(nitrito-N)rhodate was assessed in a murine local lymph node assay (LLNA) conducted in accordance with OECD Test Guideline 429 and to GLP. Following a preliminary test using a concentration of 25% w/w, female CBA/Ca mice (5/group) received 25 µL applications of the test material, in propylene glycol at 0, 5, 10 or 25%, to the skin of both ears for three consecutive days. Two additional groups of 5 females were respectively treated with propylene glycol alone and phenylacetaldehyde, a known sensitiser, at 2.5%.
Mice were monitored for mortality and overt signs of toxicity, as well as changes in body weight. Three days after the induction period (on day six), mice were given tail vein injections of radiolabelled thymidine, and were sacrificed after approximately five hours. Lymph nodes were excised and processed for radioactivity.
No signs of skin irritation or systemic toxicity were observed in the preliminary test. In the main experiment, SI values were 1.19, 0.96 and 1.36 for animals given respective concentrations of 5%, 10% and 25%. An SI value of over 3 is judged to be indicative of a substance being sensitising. Hence, under the conditions of this assay, diammonium sodium hexakis(nitrito-N)rhodate was considered non-sensitising.
Based on the results of this study, diammonium sodium hexakis(nitrito-N)rhodate does not warrant classification for skin sensitisation, according to EU CLP criteria (EC 1272/2008).
Reference
In the range-finding study, there were no signs of systemic toxicity, visual skin irritation, or ≥25% increased ear thickness (considered a sign of local irritation).
Table 1 Individual Disintegrations per Minute and Stimulation Indices
Treatment Group |
Animal Number |
dpm/ |
Mean dpm/Animal |
Stimulation Indexb |
Result |
Vehicle |
1-1 |
1030.91 |
2038.00 |
N/A |
N/A |
1-2 |
2227.51 |
||||
1-3 |
3264.38 |
||||
1-4 |
1801.09 |
||||
1-5 |
1866.09 |
||||
Test Item |
2-1 |
1495.69 |
2421.31 |
1.19 |
Negative |
2-2 |
1993.61 |
||||
2-3 |
2898.45 |
||||
2-4 |
2752.74 |
||||
2-5 |
2966.04 |
||||
Test Item |
3-1 |
1719.93 |
1949.44 |
0.96 |
Negative |
3-2 |
1565.86 |
||||
3-3 |
2793.73 |
||||
3-4 |
1963.41 |
||||
3-5 |
1704.28 |
||||
Test Item |
4-1 |
1923.37 |
2781.17 |
1.36 |
Negative |
4-2 |
3983.18 |
||||
4-3 |
2742.12 |
||||
4-4 |
2399.61 |
||||
4-5 |
2857.56 |
||||
Positive Control Item 2.5% v/v in |
5-1 |
25068.56 |
12617.71 |
6.19 |
Positive |
5-2 |
16448.63 |
||||
5-3 |
10121.97 |
||||
5-4 |
5236.74 |
||||
5-5 |
6212.65 |
The results of the statistical analysis of the data indicated there was no significant difference between the control group and the test groups.
dpm= Disintegrations per minute
N/A = Not applicable
a= Total number of lymph nodes per animal is 2
b= Stimulation Index of 3.0 or greater indicates a positive result
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No relevant human skin sensitisation data were identified. No in vitro skin sensitisation studies were identified, or are required, as a reliable in vivo study is already available.
The skin sensitising potential of diammonium sodium hexakis(nitrito-N)rhodate was assessed in a mouse LLNA conducted in accordance with OECD Test Guideline 429 and to GLP. Following a preliminary test using a concentration of 25% w/w, female CBA/Ca mice (5/group) received 25 µL applications of the test material, in propylene glycol at 0, 5, 10 or 25%, to the skin of both ears for three consecutive days. Two additional groups of 5 females were respectively treated with propylene glycol alone and phenylacetaldehyde, a known sensitiser, at 2.5%. Mice were monitored for mortality and overt signs of toxicity, as well as changes in body weight. Three days after the induction period (on day six), mice were given tail vein injections of radiolabelled thymidine, and were sacrificed after approximately five hours. Lymph nodes were excised and processed for radioactivity. No signs of skin irritation or systemic toxicity were observed in the preliminary test. In the main experiment, SI values were 1.19, 0.96 and 1.36 for animals given respective concentrations of 5%, 10% and 25%. An SI value of over 3 was judged to be indicative of a substance being sensitising. Hence, under the conditions of this assay, diammonium sodium hexakis(nitrito-N)rhodate was considered non-sensitising (Henzell, 2013).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No respiratory tract sensitisation data are available. A new study was not conducted as no standard and validated test method is available and it is not a REACH Standard Information Requirement.
Justification for classification or non-classification
Based on the results of the available and reliable murine LLNA assay, diammonium sodium hexakis(nitrito-N)rhodate does not warrant classification for skin sensitisation, according to EU CLP criteria (EC 1272/2008).
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