Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 209-599-5 | CAS number: 587-26-8
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 Nov- 30 Nov 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-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:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, ländlichen Raum und Verbraucherschutz, Mainzer Straße 80, 65189 Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dilanthanum tricarbonate
- EC Number:
- 209-599-5
- EC Name:
- Dilanthanum tricarbonate
- Cas Number:
- 587-26-8
- Molecular formula:
- La2(CO3)3
- IUPAC Name:
- dilanthanum tricarbonate
Constituent 1
Method
- Target gene:
- His operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100, TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Induced rat liver S9 is used as metabolic activation system. S9 is prepared from 8-12 weeks old male Wistar Hanlbm rats induced by applications of 80 mg/kg bw Phenobarbital (i.p.) and beta-Naphthoflavone p.o. each on three consecutive days.
- Test concentrations with justification for top dose:
- Pre-experiment / Experiment I: with and without S9: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate
Experiment II: with and without S9: 33, 100, 333, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (test substance and positive controls 4-nitro-o-phenylene-diamine and 2-aminoanthracene) and deionised water (positive controls sodium azide and methylmethanesulfonate)
- Justification for choice of solvent/vehicle: DMSO was chosen for the test substancebecause of its solubility properties and its relative non-toxicity to bacteria
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: TA1535 and TA100: 10 µg/plate sodium azide; TA1537+TA98: 4-nitro-o-phenylene-diamine (50µg/plate in TA1537 and 10 µg/plate in TA98); TA102: methylmethanesulfonate (4µL/plate); +S9: all strains 2-aminoanthracene (2.5 µg/plate; 10 µg/plate in TA102)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation test (experiment I) and preincubation assay (experiment II)
DURATION
- Preincubation period: none for the experiment I (direct plate incorporation)
- Preincubation period: 60 minutes for the experiment II
- Incubation time: 48 hours
NUMBER OF REPLICATIONS: 2 (for each strain and dose level including the untreated, vehicle and positive controls three plates were used)
- 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 thrice (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.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100, TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1a: Number of revertants per plate in pre-experiment / experiment I (mean of three plates)
|
TA 1535 |
TA 1537 |
TA 98 |
|||||||||
Concentration |
- S9 |
+ S9 |
Precipitate (yes/no) |
Cytotox (yes/no) |
- S9 |
+ S9 |
Precipitate(yes/no) |
Cytotox (yes/no) |
- S9 |
+ S9 |
Precipitate(yes/no) |
Cytotox (yes/no) |
DMSO |
19 |
27 |
no |
no |
11 |
16 |
no |
no |
21 |
30 |
no |
no |
Untreated |
15 |
26 |
no |
no |
9 |
16 |
no |
no |
29 |
37 |
no |
no |
3 |
26 |
26 |
no |
no |
10 |
15 |
no |
no |
29 |
30 |
no |
no |
10 |
24 |
23 |
no |
no |
13 |
16 |
no |
no |
24 |
31 |
no |
no |
33 |
23 |
25 |
no |
no |
11 |
14 |
no |
no |
24 |
32 |
no |
no |
100 |
21 |
24 |
no |
no |
10 |
15 |
no |
no |
26 |
30 |
no |
no |
333 |
18 |
26 |
Yes (+S9) |
no |
11 |
22 |
Yes (+S9) |
no |
25 |
37 |
Yes (+S9) |
no |
1000 |
17 |
27 |
yes |
no |
11 |
17 |
yes |
no |
27 |
27 |
yes |
no |
2500 |
18 |
31 |
yes |
no |
12 |
16 |
yes |
no |
21 |
25 |
yes |
no |
5000 |
19 |
19 |
yes |
no |
6 |
9 |
yes |
no |
22 |
26 |
yes |
no |
NaN3 |
1361 |
|
|
|
|
|
|
|
|
|
|
|
4-NOPD |
|
|
|
|
73 |
|
|
|
352 |
|
|
|
MMS |
|
|
|
|
|
|
|
|
|
|
|
|
2-AA |
|
220 |
|
|
|
244 |
|
|
|
1462 |
|
|
Table 1b: Number of revertants per plate in pre-experiment / experiment I (mean of three plates)
|
TA 100 |
TA 102 |
||||||
Concentration |
- S9 |
+ S9 |
Precipit.ate |
Cytotox (yes/no) |
- S9 |
+ S9 |
Precipitate(yes/no) |
Cytotox (yes/no) |
DMSO |
128 |
140 |
no |
no |
488 |
540 |
no |
no |
Untreated |
140 |
170 |
no |
no |
474 |
590 |
no |
no |
3 |
141 |
138 |
no |
no |
478 |
608 |
no |
no |
10 |
121 |
140 |
no |
no |
471 |
496 |
no |
no |
33 |
135 |
150 |
no |
no |
418 |
537 |
no |
no |
100 |
125 |
140 |
no |
no |
433 |
504 |
no |
no |
333 |
136 |
146 |
Yes (+S9) |
no |
431 |
496 |
Yes (+S9) |
no |
1000 |
111 |
135 |
yes |
no |
467 |
457 |
yes |
no |
2500 |
122 |
144 |
yes |
no |
476 |
534 |
yes |
no |
5000 |
118 |
117 |
yes |
no |
336 |
460 |
yes |
no |
NaN3 |
2161 |
|
|
|
|
|
|
|
4-NOPD |
|
|
|
|
|
|
|
|
MMS |
|
|
|
|
4759 |
|
|
|
2-AA |
|
1866 |
|
|
|
2042 |
|
|
NaN3: sodium azide; 4-NOPD: 4 -nitro-o-phenylene-diamine; MMS: methylmethanesulfonate; 2-AA: 2-aminoanthracene
Table 2a: Number of revertants per plate in experiment II (mean of three plates)
|
TA 1535 |
TA 1537 |
TA 98 |
|||||||||
Concentration |
- S9 |
+ S9 |
Precipitate (yes/no) |
Cytotox (yes/no) |
- S9 |
+ S9 |
Precipitate(yes/no) |
Cytotox (yes/no) |
- S9 |
+ S9 |
Precipitate(yes/no) |
Cytotox (yes/no) |
DMSO |
22 |
24 |
no |
no |
10 |
19 |
no |
no |
32 |
40 |
no |
no |
Untreated |
26 |
21 |
no |
no |
13 |
25 |
no |
no |
25 |
38 |
no |
no |
33 |
24 |
25 |
no |
no |
7 |
19 |
no |
no |
25 |
38 |
no |
no |
100 |
20 |
27 |
no |
no |
11 |
18 |
no |
no |
32 |
36 |
no |
no |
333 |
21 |
29 |
no |
no |
10 |
18 |
no |
no |
19 |
35 |
no |
no |
1000 |
21 |
26 |
no |
no |
12 |
18 |
no |
no |
24 |
38 |
no |
no |
2500 |
21 |
28 |
no |
no |
11 |
15 |
no |
no |
27 |
38 |
no |
no |
5000 |
22 |
32 |
yes |
no |
9 |
15 |
yes |
no |
27 |
37 |
yes |
no |
NaN3 |
1274 |
|
|
|
|
|
|
|
|
|
|
|
4-NOPD |
|
|
|
|
125 |
|
|
|
467 |
|
|
|
MMS |
|
|
|
|
|
|
|
|
|
|
|
|
2-AA |
|
262 |
|
|
|
129 |
|
|
|
1352 |
|
|
Table 2b: Number of revertants per plate in experiment II (mean of three plates)
|
TA 100 |
TA 102 |
||||||
Concentration |
- S9 |
+ S9 |
Precipitate (yes/no) |
Cytotox (yes/no) |
- S9 |
+ S9 |
Precipitate(yes/no) |
Cytotox (yes/no) |
DMSO |
126 |
152 |
no |
no |
341 |
343 |
no |
no |
Untreated |
176 |
136 |
no |
no |
372 |
390 |
no |
no |
33 |
126 |
109 |
no |
no |
339 |
367 |
no |
no |
100 |
113 |
128 |
no |
no |
344 |
429 |
no |
no |
333 |
128 |
133 |
no |
no |
358 |
457 |
no |
no |
1000 |
117 |
108 |
no |
no |
298 |
340 |
no |
no |
2500 |
111 |
132 |
no |
no |
321 |
419 |
no |
no |
5000 |
116 |
126 |
yes |
no |
324 |
417 |
yes |
no |
NaN3 |
1679 |
|
|
|
|
|
|
|
4-NOPD |
|
|
|
|
1984 |
|
|
|
MMS |
|
|
|
|
|
|
|
|
2-AA |
|
1688 |
|
|
|
2112 |
|
|
NaN3: sodium azide; 4-NOPD: 4 -nitro-o-phenylene-diamine; MMS: methylmethanesulfonate; 2-AA: 2-aminoanthracene
The results of the second experiment are comparable to the first. No toxic effects occured in the test groups with and without metabolic activation.
Precipitation of the test solution in agar was observed from 1000 µg/plate without metabolic activation and from 333 µg/plate with metabolic activation in experiment I, and at 5000 µg/plate with and without S9 mix in experiment II. Due to precipitation of the test item the colonies were partly counted manually.
No substantial increase in revertant colony numbers in any of the five tester strains was observed following treatment with Lanthanum carbonate at any concentration level, neither in the presence nor absence of metabolic activation. 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. Therefore, Lanthanum carbonate is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.