Mercaptoacetic acid, monoester with propane-1,2,3-triol

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:

14-Feb-1992 - 07-Jul-1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP and Guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

incomplete strain selection

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Mercaptoacetic acid, monoester with propane-1,2,3-triol

EC Number:

250-264-8

EC Name:

Mercaptoacetic acid, monoester with propane-1,2,3-triol

Cas Number:

30618-84-9

Molecular formula:

C5H10O4S

IUPAC Name:

2,3-dihydroxypropyl 2-sulfanylacetate

Test material form:

solid - liquid: suspension

Details on test material:

- Name of test material (as cited in study report): Monothioglycolate de Glycerol 68 %
- Analytical purity: 67.9 %

Method

Target gene:

Histidine operon

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

Test concentrations with justification for top dose:

20 mg/mL Monothioglycolate (29,45 mg Glyceryl Monothioglycolate/mL)

Vehicle / solvent:

distilled water

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

for TA 100, TA 1535 without S9

Migrated to IUCLID6: 1 µg / plate

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

for TA 1537 without S9

Migrated to IUCLID6: 50 µg / plate

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

for TA 98, TA 1538 without S9

Migrated to IUCLID6: 0.5 µg / plate

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-anthramine: 2 µg / plate for TA-1535 and TA-1537; 1 µg / plate for TA-1538, TA-98 and TA-100

Remarks:

for all strains with S9

Details on test system and experimental conditions:

METHOD OF APPLICATION: plate incorporation method (without S9), preincubation method (with S9)

DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 - 72 h


NUMBER OF CELLS EVALUATED: See evaluation criteria

Evaluation criteria:

The test substance is considered as mutagenic if, for each test, it induces a doubling in the number of revertants when compared to that in the negative and/or solvent controls, for at least one of the tested strains and at one or more of the tested concentrations.

The test substance is considered as non-mutagenic if the above
criteria are not fully met.

Statistics:

A statistically significant dose relationship is investigated, using a linear regression analysis, and considered as significant if p ≤ 0.05 (for n = 18 values, the correlation coefficient r must be ≥ 0.47).

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:

Higher than or equal to 1000 µg / plate for TA-98 and TA-100 strain with and without S9 mix and at 2000 µg / plate for TA-1535 and TA 1537 without S9 mix

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

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:

Without activation at 1000 µg / plate

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'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Under the experimental conditions used the test substance Monothioglycolate de Glycerol 68 % did not show mutagenic activity in the Ames test.