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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:
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

Constituent 1
Chemical structure
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:
1,3-dihydroxypropan-2-yl 2-sulfanylacetate 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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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
Controlsopen allclose all
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
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
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
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 resultsopen allclose all
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
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.