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EC number: 240-827-6 | CAS number: 16774-21-3
- 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
Repeated dose toxicity - oral: No reliable repeated dose toxicity with the test substance is available. Braun (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test in rats according to OECD guideline 422 (GLP) with the read-across substance cerium trinitrate. Based on the results of this study, a NOAEL value for systemic toxicity of 330 mg/kg bw/day was derived.
Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity via the dermal route of exposure. Furthermore, as the substance is classified as corrosive to the skin, serious local effects may be expected after repeated dermal exposure to the diluted test item and, for reasons of animal welfare, the test should be avoided.
Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity via the inhalation route of exposure. Furthermore, due to formation of clumps, the inhalation route is unlikely a possible route of exposure as the formation of respirable suspended particulate matter is unlikely. In addition, the substance is classified as corrosive to the skin and serious local effects might be expected after repeated inhalation exposure to the diluted test item. therefore, for reasons of animal welfare, the test should be avoided.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- No reliable short term repeated dose toxicity data with the target substance is available. This endpoint is covered based on data with the source substance cerium trinitrate. Justification for the read across approach is included in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 330 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: The NOAEL for systemic toxicity of the parent animals was considered to be 330 mg/kg/day as two animals treated with 1000 mg/kg/day dies as a result of the treatment-related effects in the stomach (local irritation)
- Dose descriptor:
- NOEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 330 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: oral
No reliable repeated dose toxicity study is available with the test substance cerium ammonium nitrate. Braun (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test in RccHan: WIST (SPF) rats with the read-across substance cerium trinitrate. Cerium trinitrate was administered to male rats for 47 days and to female rats for at least 6 weeks. The study was performed according to OECD guideline 422 and in compliance with good Laboratory Practice (GLP).
The following dose levels (expressed as anhydrous active ingredient) were applied:
Group 1: 0 mg/kg bw/day (control group)
Group 2: 110 mg/kg bw/day
Group 3: 330 mg/kg bw/day
Group 4: 1000 mg/kg bw/day
Control animals were dosed with the vehicle (bidistilled water) alone.
The NOEL for systemic toxicity of the parent animals was considered to be 110 mg/kg/day, based upon the changes in the stomachs of rats treated with 330 mg/kg bw/day and 1000 mg/kg bw/day as well as differences in the mean daily food consumption/body weight development at 1000 mg/kg bw/day. In addition, two animals treated with 1000 mg/kg bw/day died as a result of the stomach findings. Therefore, a NOAEL for systemic toxicity of the parent animals was defined to be 330 mg/kg bw/day.
Although an NOAEL (parents) for systemic toxicity was estimated in this study, it can not be considered relevant for systemic toxicity after repeated oral exposure as this value is based on local effects rather than systemic effects: the morphological changes in the stomachs were reported to be local effects (irritation after repeated oral gavage) rather than systemic toxicity and the differences in the food consumption/body weight were considered secondary to the changes in the stomach.
Repeated dose toxicity: inhalation
A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Furthermore, due to formation of clumps, the inhalation route is unlikely a possible route of exposure as the formation of reqpirable suspended particulate matter is unlikely. In addition, the substance is classified as corrosive to the skin and serious local effects might be expected after repeated inhalation exposure to the diluted test item. Therefore, for reasons of animal welfare, the test should be avoided.
Repeated dose toxicity: dermal
A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. Furthermore, as the substance is classified as corrosive to the skin, serious local effects may be expected after repeated dermal exposure to the diluted test item and, for reasons of animal welfare, the test should be avoided.
Annex IX further testing:
The read-across substance cerium trinitrate has been tested in an OECD 422 study. In the high (1000 mg/kg bw/d) and the mid (330 mg/kg bw/d) dose groups, morphological changes in the stomach were observed. However, these effects are considered as local (irritation after repeated oral gavage of the compound) rather than systemic effects. In the high dose group, differences in the mean daily food consumption/body weight development at 1000 mg/kg bw/day were observed and considered secondary to the changes in the stomach. In addition, in the highest dose group, two animals died as a result of the stomach findings (local effects).
Although the NOAEL for systemic toxicity in the study was derived to be
330 mg/kg bw/day, there is suffiecient evidence that this value is not
relevant for systemic toxicity but for the local effects in the stomach.
On the basis of these results it can be concluded that no systemic
adverse effects need to be addressed by a subchronic test (according to
OECD guideline 408). The read-across justification is added in Section
13 of IUCLID. Therefore, and considering the animal welfare, no further
testing is advised.
Justification for classification or non-classification
Based on the available data of the read-across substance cerium trinitrate and according to the criteria of the CLP Regulation, cerium ammonium nitrate should not be classified for STOT repeated exposure via the oral route.
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