Methanesulphonic acid

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

lack of detailed documentation

GLP compliance:

yes

Remarks:

Life Science Research, England

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Methanesulphonic acid

EC Number:

200-898-6

EC Name:

Methanesulphonic acid

Cas Number:

75-75-2

Molecular formula:

CH4O3S

IUPAC Name:

methanesulfonic acid

Details on test material:

- Name of test material (as cited in study report): methanesulfonic acid
- Physical state: colourless liquid
- Composition of test material, percentage of components: methanesulphonic acid (70%)
- Lot/batch No.: K15J
- Storage condition of test material: room temperature and protected from light

Method

Target gene:

histidin auxotrophy

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

10, 32, 100, 316, 1000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

without S9 mix

Migrated to IUCLID6: 2 µg/plate for TA1535 and TA100

Controls 2

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

without S9 mix

Migrated to IUCLID6: 5 µg/plate for TA1538 and TA98

Controls 3

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without S9 mix

Migrated to IUCLID6: 50 µg/plate for TA1537

Controls 4

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

with and without S9 mix

Migrated to IUCLID6: 5 µg/plate for TA1537, TA1538, TA100 and TA98

Controls 5

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene, 5 µg/plate for TA1537

Remarks:

with and without S9 mix

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

NUMBER OF REPLICATIONS: 2

DETERMINATION OF CYTOTOXICITY: yes
- Method: other: growth inhibition, observed as thinning of background lawn of non-revertant cells and reduction in colony numbers

Results and discussion

Test results

Test results 1

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:

1000 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

1000 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES: A preliminary toxicity test was performed in strain TA98 at concentration range of 2.5-5000 µg/plate. Complete growth inhibition was obtained with methanesulphonic acid at levels of 2500 and 5000 µg/plate. Normal growth was obtained at 500 µg per plate. An intermediate level of 1000 µg/plate was therefore selected as the top exposure level for use in the main assays.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Reverants colony counts in Test 1 (mean ± SD) 

Dose (µg/plate)	TA 98		TA 100		TA 1535		TA 1537		TA1538
	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9
1000	19±3^a	31±7^a	84±5^a	101±4^a	15±1^a	15±1^a	7±1^a	7±0^a	20±1^a	25±1^a
316	41±2	46±2	133±3	114±2	19±2	19±2	8±1	7±1	27±3	26±4
100	44±2	42±2	149±2	112±2	20±2	20±1	7±3	7±2	23±3	22±2
32	40±1	46±4	125±6	115±3	20±1	20±1	9±0	8±2	25±1	25±2
10	44±2	41±2	125±10	115±2	19±2	18±1	7±1	8±2	22±1	25±1
0	44±1	45±1	126±3	116±6	21±3	18±1	7±2	8±2	27±1	26±2
B(a)P	772±11	42±2	1133±52	108±6	-	-	203±12	6±1	352±32	23±2
2-NF	-	531±12	-	-	-	-	-	-	-	703±3
Sodium Azide	-	-	-	944±40	-	783±18	-	-	-	-
9-AA	-	-	-	-	755±33	19±3	-	210±21	-	-

^a Slight thinning of the background lawn of non-reverant cells was observed

B(a)P: Benzo(a)pyrene; 2 -NF: 2 -Nitrofluorene; 9 -AA: 9 -Aminoacridine

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation