Samarium (III) chloride hexahydrate

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:

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

Reference substance name:

Samarium chloride

IUPAC Name:

Samarium chloride

Constituent 2

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.