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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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:
2012-05-02 to 2012-05-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
2011-04-11 Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, 55116 Mainz, Germany
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Samarium chloride
IUPAC Name:
Samarium chloride
Constituent 2
Chemical structure
Reference substance name:
Samarium (III) chloride hexahydrate
EC Number:
233-797-0
EC Name:
Samarium (III) chloride hexahydrate
Cas Number:
10361-82-7
Molecular formula:
Cl3Sm
IUPAC Name:
samarium (III) chloride hexahydrate
Constituent 3
Reference substance name:
Samarium Chloride
IUPAC Name:
Samarium Chloride
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): Samarium Chloride
- Molecular formula (if other than submission substance): Cl3Sm
- Molecular weight (if other than submission substance): not stated
- Analytical purity: > 99%
- Composition of test material, percentage of components: > 99 %
- Lot/batch No.: PR 090142/2
- Expiration date of the lot/batch: May 2018
- Stability under test conditions: not stated
- Storage condition of test material: The test item was stored in a closed vessel dry at room temperature: (20 +- 5°C).

Method

Target gene:
his operon
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
Metabolic activation:
with and without
Metabolic activation system:
Liver S-9 Fraction of Aroclor 1254-induced male Sprague-Dawley rat and Sprague-Dawley hamster. 10 and 30% S-9 mixes were tested.
Test concentrations with justification for top dose:
TA 97a, TA 98, TA 100, TA 102 and TA 1535 (first experiment):
without and with activation (10% HLI, 10% RLI): 0, 53, 152, 503, 1502 and 5047 µg/plate;
with activation (30% HLI, 30% RLI): 0, 53, 152, 503, 1502 and 5047 µg/plate

TA 97a, TA 98, TA 100, TA 102 and TA 1535 (second experiment):
without and with activation (10% HLI, 10% RLI): 0, 313, 627, 1255, 2505 and 5002 µg/plate;
with activation (30% HLI, 30% RLI): 0, 313, 627, 1255, 2505 and 5002 µg/plate
Vehicle / solvent:
water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
benzo(a)pyrene
other: 4-Nitro-1,2-phenylene diamine and 2-Amino-anthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION:
- Plate incorporation method (first experiment)
- preincubation (second experiment)


DURATION
- Preincubation period: 20 min.
- Temperature: 37°C
- Exposure duration: 2 days

NUMBER OF REPLICATIONS: 4

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
The colonies were counted visually, the numbers were recorded. A spreadsheet software (Microsoft Excel (R)) was used to calculate mean values and standard deviations of each treatment, solvent control and positive control. The increase factor f(I) of revertant induction (mean revertants divided by mean spontaneous revertants) were also calculated.
A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor >=2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity.

Results and discussion

Test results
Species / strain:
other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
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

First Experiment:

The mean revertant values of the four replicates are presented in the following table. Concentrations of the test item are stated as nominal concentrations, as suspensions had to be tested due to the poor solubility of the test item. As no complete dissolution was possible, undissolved particles were visible on the plates.

Strain     TA97a    TA98    TA100    TA102    TA1535  
Induction    -S9  +S9  -S9  +S9  -S9  +S9  -S9  +S9  -S9  +S9
 H2O  Mean 121 110 18 20 128 112 125 122 19 17
   sd 4.0  6.8 2.8 2.2 11.8 22.1 9.1 14.2 1.5 0.0
 DMSO  Mean 119 104 20 19 107 118 136 133 19 18
   sd 7.5 9.5 1.3 3.7 2.7 14.0 17.7 18.2 0.8 0.0
Positive Controls Mean  639 508 258 122 564 539 475 581 531 167
   sd 112 59 24 18 51 59 22 38 61 12
   f(I) 5.37 4.88 12.90 6.42 4.41 4.57 3.49 4.37 27.95 9.28
5047 µg/pl.  Mean 115 114 16 15 114 114 120 120 20 19
   sd 10 6 2 2 16 6 4 6 1 1
   f(I) 0.95 1.04 0.89 0.75 0.89 1.02 0.96 0.98 1.05 1.12
1502 µg/pl.  Mean 106 119 17 17 120 130 128 129 19 21
   sd 8 11 3 1 17 21 12 12 1 2
   f(I) 0.88 1.08 0.94 0.85 0.94 1.16 1.02 1.06 1.00 1.24
503 µg/pl.  Mean 113 117 15 18 106 134 133 116 15 17
   sd 8 6 4 5 10 11 20 12 5 3
   f(I) 0.93 1.06 0.83 0.90 0.83 1.20 1.06 0.95 0.79 1.0
152 µg/pl.  Mean 113 116 16 19 109 117 116 124 17 19
   sd 4 9 1 3 7 9 9 13 3 1
   f(I) 0.93 1.05 0.89 0.95 0.85 1.04 0.93 1.02 0.89 1.12
53 µg/pl.  Mean 111 115 20 18 117 125 126 121 17 16
   sd 6 6 4 1 7 5 16 19 2 3
   f(I) 0.92 1.05 1.11 0.90 0.91 1.12 1.01 0.99 0.89 0.94

Second Experiment:

The mean revertant values of the four replicates are presented in the following table. Concentrations of the test item are stated as nominal concentrations, as suspensions had to be tested due to the poor solubility of the test item. As no complete dissolution was possible, undissolved particles were visible on the plates.

Strain     TA97a    TA98    TA100    TA102    TA1535  
Induction    -S9  +S9  -S9  +S9  -S9  +S9  -S9  +S9  -S9  +S9
 H2O  Mean  108  119  13 15   67  77  126  142  14  15
   sd  6.7  5.7  2.4 1.6   2.6  11.2  16.5  5.4  3.8  1.9
 DMSO  Mean  127  126  14  14  78  73  136  145  16  14
   sd  9.1  11.1  3.4  1.0  8.3  8.8  14.9  8.0  3.7  1.0
Positive Controls Mean   509  531  245  249  419  572  605  601  202  235
   sd  21  32  18  14  159  38  66  45  20  4
   f(I)  4.01  4.21  17.50  17.79 6.25 7.84 4.45 4.14 14.43 16.79
5002 µg/pl.  Mean  114  117  13  14  83  88  134  134  15  14
   sd  6  4  2  3  10  10  13  10  2  1
   f(I)  1.06  0.98  1.00  0.93  1.24  1.14  1.06  0.94  1.07  0.93
2505 µg/pl.  Mean  112  109  13  13  82  79  145  141  15  15
   sd  4  7  4  4  6  5  7  7  3  2
   f(I)  1.04  0.92  1.00  0.87  1.22  1.03  1.15  0.99  1.07  1.00
1255 µg/pl.  Mean  118  110  13  13  71  88  145  123  14  16
   sd  4  1  3  1  3  3  7  7  2  2
   f(I)  1.09  0.92  1.00  0.87  1.06  1.14  1.15  0.87  1.00  1.07
627 µg/pl.  Mean  120  111  14  14  74  78  124  135  13  14
   sd  2  8  2  3  2  6  3  9  3  1
   f(I)  1.11  0.93  1.08  0.93  1.10  1.01  0.98  0.95  0.93  0.93
313 µg/pl.  Mean  110  113  14  14  78  84  126  127  15  16
   sd  6  3  3  3  4  12  18  19  2  3
   f(I)  1.02  0.95  1.08  0.93  1.16  1.09  1.00  0.89  1.07  1.07

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metaboic activation
Executive summary:

The test item didn't show mutagenic effects in both experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants (solvent only). Cytotoxicity of the test item was not detected. The background lawn was visible and the number of revertants was not significantly decreased.

As no complete dissolution was possible, undissolved particles were visible on the plates.

Therefore it can be stated, that under the test conditions, the test item Samarium chloride is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535.