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EC number: 233-297-2 | CAS number: 10108-73-3
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 04-NOV-2005 to 06-JAN-2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Cited as Directive 2000/32/EC, B.13/14
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Cerium trinitrate
- EC Number:
- 233-297-2
- EC Name:
- Cerium trinitrate
- Cas Number:
- 10108-73-3
- Molecular formula:
- Ce.3HNO3
- IUPAC Name:
- cerium trinitrate
- Test material form:
- solid: crystalline
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100, and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 fraction of rats induced with Phenobarbital / beta-Naphthoflavone + cofactors (= S9 mix)
- Test concentrations with justification for top dose:
- Pre-experiment (Experiment I): 3, 10, 33, 100, 333, 1000, 2500, and 5000 µg/plate
Experiment II: 33, 100, 333, 1000, 2500, and 5000 µg/plate
for details see table 1 below - Vehicle / solvent:
- > Vehicle(s)/solvent(s) used: deionised water
> Justification for choice of solvent/vehicle: the solvent was chosen because of its solubility properties
> Vehicle controls tested: medium with solvent or vehicle alone
> volume of vehicle/solvent in the medium: 100 µL/2600 µL medium)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreatment and solvent controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- medium with solvent or vehicle alone
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: (NaN3, 10 µg/pl) in TA1535 and TA100 without S9 mix
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine (4-NOPD, 10 and 50 µg/pl) in TA98 and TA1537, without S9 mix, respectively
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Migrated to IUCLID6: (MMS, 4 µg/pl) in TA 102 without S9 mix
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA, 2.5 µg/pl, 10 µg/pl with TA 102) in TA1535, TA1537, TA98, TA100 and TA102 with S9 mix
- Details on test system and experimental conditions:
- - METHOD OF APPLICATION:
> in agar (plate incorporation) in experiment I,
> preincubation in experiment II
- DURATION:
> Preincubation period (experiment II): 60 minutes at 37°C
> Exposure duration: 48 hours at 37°C
- NUMBER OF REPLICATES PER CONCENTRATION: 3
- Determination of cytotoxicity: Toxicity of the test item can be evident as a reduction in the number of spontaneous revertants or a cleaning of the bacterial background lawn.
- Other: Scoring method: The colonies were counted using the Petri Viewer Mk2 (Perceptive Instruments Ltd, Suffolk CB 7BN, UK). - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and TA 102) or thirce (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- not mandatory
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity observed in TA 98 without S9-mix (experiment II) at 2500 and 5000 µg/pl, and in TA 1537 and TA 98 at 5000 µg/pl with S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - TEST-SPECIFIC CONFOUNDING FACTORS:
> Precipitation: precipitation was observed from 1000 µg/plate to 5000 µg/plate in each experiment and in each strain.
- Comparison with historical control data: The laboratory's historical control range was exceeded in the untreated and solvent control of strain TA 102 with and without metabolic activation in experiment II. These deviations are judged to be based on biologically irrelevant fluctuations in the number of colonies and have no impact on the outcome of the study.
SEE DETAILED RESULTS IN TABLES 2 AND 3 BELOW
Any other information on results incl. tables
Table 2: Number of revertants per plate in experiment I (mean of 3 plates) (plate incorporation)
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
||||||||||
Conc. |
- MA |
+ MA |
Precipit. |
- MA |
+ MA |
Precipit. |
- MA |
+ MA |
Precipit. |
- MA |
+ MA |
Precipit. |
- MA |
+ MA |
Precipit. |
0* |
16 |
26 |
no |
10 |
17 |
no |
33 |
44 |
no |
139 |
163 |
no |
449 |
596 |
no |
Untreated |
21 |
24 |
no |
10 |
18 |
no |
40 |
56 |
no |
140 |
174 |
no |
447 |
600 |
no |
3 |
16 |
27 |
no |
12 |
13 |
no |
34 |
42 |
no |
147 |
169 |
no |
455 |
594 |
no |
10 |
21 |
23 |
no |
13 |
14 |
no |
30 |
49 |
no |
162 |
166 |
no |
468 |
606 |
no |
33 |
25 |
27 |
no |
7 |
20 |
no |
31 |
44 |
no |
143 |
161 |
no |
435 |
620 |
no |
100 |
21 |
25 |
no |
6 |
20 |
no |
27 |
49 |
no |
121 |
140 |
no |
469 |
607 |
no |
333 |
20 |
18 |
no |
14 |
18 |
no |
36 |
50 |
no |
145 |
154 |
no |
449 |
618 |
no |
1000 |
21 |
21 |
yes |
7 |
14 |
yes |
33 |
40 |
yes |
137 |
165 |
yes |
443 |
619 |
yes |
2500 |
17 |
18 |
yes |
6 |
9 |
yes |
23 |
33 |
yes |
126 |
137 |
yes |
406 |
498 |
yes |
5000 |
18 |
19 |
yes |
7 |
7 |
yes |
23 |
22 |
yes |
98 |
119 |
yes |
321 |
386 |
yes |
NaN3 |
1533 |
2196 |
|||||||||||||
4-NOPD |
97 |
418 |
|||||||||||||
MMS |
5592 |
||||||||||||||
2-AA |
306 |
229 |
1666 |
2657 |
2836 |
*solvent control with water
MA: metabolic activation
NaN3: sodium azide
2 -AA: 2 -aminoanthracene
MMS: methyl methane sulfonate
4 -NOPD: 4 -nitro-o-phenylene-diamine
Table 3: Number of revertants per plate in experiment II (mean of 3 plates) (preincubation)
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
||||||||||
Conc. |
- MA |
+ MA |
Precipit. |
- MA |
+ MA |
Precipit. |
- MA |
+ MA |
Precipit. |
- MA |
+ MA |
Precipit. |
- MA |
+ MA |
Precipit. |
0* |
22 |
31 |
no |
13 |
13 |
no |
46 |
41 |
no |
171 |
217 |
no |
459 |
693 |
no |
Untreated |
17 |
37 |
no |
14 |
16 |
no |
32 |
43 |
no |
185 |
225 |
no |
482 |
676 |
no |
33 |
20 |
38 |
no |
4 |
16 |
no |
24 |
41 |
no |
188 |
192 |
no |
482 |
661 |
no |
100 |
17 |
26 |
no |
12 |
17 |
no |
22 |
41 |
no |
160 |
217 |
no |
484 |
708 |
no |
333 |
23 |
24 |
no |
10 |
16 |
no |
31 |
40 |
no |
177 |
196 |
no |
494 |
708 |
no |
1000 |
20 |
28 |
yes |
9 |
15 |
yes |
32 |
47 |
yes |
180 |
213 |
yes |
475 |
668 |
yes |
2500 |
28 |
22 |
yes |
11 |
6 |
yes |
19 |
40 |
yes |
166 |
177 |
yes |
512 |
713 |
yes |
5000 |
11 |
20 |
yes |
12 |
3 |
yes |
18 |
10 |
yes |
171 |
191 |
yes |
494 |
623 |
yes |
NaN3 |
1518 |
||||||||||||||
4-NOPD |
92 |
423 |
2148 |
||||||||||||
MMS |
4775 |
||||||||||||||
2-AA |
316 |
209 |
2249 |
2765 |
3081 |
*solvent control with water
MA: metabolic activation
NaN3: sodium azide
2 -AA: 2 -aminoanthracene
MMS: methyl methane sulfonate
4 -NOPD: 4 -nitro-o-phenylene-diamine
Applicant's summary and conclusion
- Conclusions:
- No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with cerium trinitrate at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. - Executive summary:
In a reverse gene mutation assay in bacteria (Sokolowski A, 2006), strains TA1535, 1537, 98, 100 and 102 of S. typhimurium were exposed to cerium trinitrate, (75.03 % a.i.), at concentrations of 0 - 5000 µg/plate in the presence and absence of mammalian metabolic activation [plate co-incubation and pre-incubation].
Cerium trinitrate was tested up to limit concentration (5000 µg/plate). The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background with cerium trinitrate in each strain with and without metabolic activation.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline EU B.13/14 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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