Mullite

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:

2009-12-07 - 2010-03-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Mullite

EC Number:

215-113-2

EC Name:

Mullite

Cas Number:

1302-93-8

Molecular formula:

Al6O13Si2

IUPAC Name:

Mullite; Al6O13Si2

Method

Target gene:

TA97a: hisD6610, uvrB, pKM 101, rfa
TA 98: hisD3052, uvrB, pKM 101, rfa
TA 100 : hisG46, uvrB, pKM 101, rfa
TA102: hisG428, pKM 101, rfa
TA1535 : hisG46, uvrB, rfa.

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 97

Additional strain / cell type characteristics:

other: hisD6610, uvrB, pKM 101, rfa

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

other: hisD3052, uvrB, pKM 101, rfa

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

other: hisG46, uvrB, pKM 101, rfa

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 102

Additional strain / cell type characteristics:

other: hisG428, pKM 101, rfa

Species / strain 5

Species / strain / cell type:

S. typhimurium TA 1535

Additional strain / cell type characteristics:

other: hisG46, uvrB, rfa.

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

Plate incorporation test: 5010 / 1523 / 567 / 152 / 57 µg/plate
Pre-incubation method: 4993 / 2543 / 1229 / 632 / 338 µg/plate

Vehicle / solvent:

deionised water

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 4-Nitro-1,2-phenylene diamine

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-Amino-anthracene

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 97

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

Test results 2

Species / strain:

S. typhimurium TA 98

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

Test results 3

Species / strain:

S. typhimurium TA 100

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

Test results 4

Species / strain:

S. typhimurium 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

Test results 5

Species / strain:

S. typhimurium TA 1535

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

 Mean Revertants First Experiment

Strain		TA97a		TA98		TA100		TA102		TA1535
Induction		-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
H2O	Mean	104	114	9	7	101	122	155	210	7	7
	sd	16.1	16.1	1.4	1.3	15.4	17.1	32.2	11.8	1.8	3.3
DMSO	Mean	110	116	10	9	101	101	177	194	9	7
	sd	8.2	10.1	0.6	1.3	7.4	5.3	18.0	25.1	0.5	3.7
Pos.Contr.	Mean	362	441	274	208	493	628	819	830	217	188
	sd	27	43	48	34	231	49	58	74	50	19
	f(I)	3.29	3.80	27.40	23.11	4.88	6.22	4.63	4.28	31.00	26.86
5010 µg/pl.	Mean	105	118	9	8	111	145	192	233	5	10
	sd	10	9	2	2	14	6	8	26	1	1
	f(I)	1.01	1.04	1.00	1.14	1.10	1.19	1.24	1.11	0.71	1.43
1523 µg/pl.	Mean	103	111	10	8	123	123	197	198	4	5
	sd	11	10	2	3	26	18	8	13	1	2
	f(I)	0.99	0.97	1.11	1.14	1.22	1.01	1.27	0.94	0.57	0.71
567 µg/pl.	Mean	114	117	10	9	101	133	215	182	10	9
	sd	10	8	2	1	7	23	8	18	1	2
	f(I)	1.10	1.03	1.11	1.29	1.00	1.09	1.39	0.87	1.43	1.29
152 µg/pl.	Mean	116	103	11	9	113	95	153	185	4	11
	sd	4	17	1	2	10	13	28	4	0	2
	f(I)	1.12	0.90	1.22	1.29	1.12	0.78	0.99	0.88	0.57	1.57
57 µg/pl.	Mean	120	98	6	8	109	108	234	203	8	9
	sd	5	8	1	2	15	24	42	21	2	1
	f(I)	1.15	0.86	0.67	1.14	1.08	0.89	1.51	0.97	1.14	1.29

Mean Revertants Second Experiment

Strain		TA97a		TA98		TA100		TA102		TA1535
Induction		-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
H2O	Mean	155	143	12	14	120	121	170	165	7	10
	sd	7.0	6.0	1.9	4.8	28.2	18.4	29.9	4.9	2.4	2.1
DMSO	Mean	158	153	12	13	115	128	170	155	10	10
	sd	22.3	15.2	2.5	3.6	12.1	16.0	23.8	20.0	3.3	3.1
Pos.Contr.	Mean	475	439	249	225	532	767	868	789	194	192
	sd	56	61	44	34	137	241	90	142	62	47
	f(I)	3.01	2.87	20.75	17.31	4.43	5.99	5.11	5.09	27.71	19.20
4993 µg/pl.	Mean	108	106	9	8	123	116	191	178	4	7
	sd	17	8	1	1	22	20	13	10	1	3
	f(I)	0.70	0.74	0.75	0.57	1.03	0.96	1.12	1.08	0.57	0.70
2543 µg/pl.	Mean	110	116	9	9	123	106	197	188	8	7
	sd	13	5	1	2	32	11	26	8	4	3
	f(I)	0.71	0.81	0.75	0.64	1.03	0.88	1.16	1.14	1.14	0.70
1229 µg/pl.	Mean	119	116	5	8	126	112	210	232	7	5
	sd	4	7	2	2	18	21	40	30	3	2
	f(I)	0.77	0.81	0.42	0.57	1.05	0.93	1.24	1.41	1.00	0.50
632 µg/pl.	Mean	118	115	9	8	119	111	259	238	7	6
	sd	3	4	1	3	23	7	40	8	2	2
	f(I)	0.76	0.80	0.75	0.57	0.99	0.92	1.52	1.44	1.00	0.60
338 µg/pl.	Mean	107	107	9	9	122	106	239	253	6	8
	sd	14	10	1	1	25	8	41	23	3	3
	f(I)	0.69	0.75	0.75	0.64	1.02	0.88	1.41	1.53	0.86	0.80

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

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

Executive summary:

The test item did not 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.

Therefore it can be stated, that under the test conditions, the test itemWhite Fused Mulliteis not mutagenic in the Bacterial Reverse Mutation Test usingSalmonella typhimurium,strainsTA 97a, TA 98, TA 100, TA 102 and TA 1535.