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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:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Acrylamide
EC Number:
201-173-7
EC Name:
Acrylamide
Cas Number:
79-06-1
Molecular formula:
C3H5NO
IUPAC Name:
prop-2-enamide
Details on test material:
- Name of test material (as cited in study report): AA (Acrylamide)
- Substance type: organic
- Physical state: solid
- Analytical purity: ≥98%
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: 100%
- Purity test date: no data
- Lot/batch No.: 305-91.1181 (Fluka AG, Switzerland)
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Method

Target gene:
Histidine biosynthetic pathway
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 102
Metabolic activation:
with and without
Metabolic activation system:
S9 Mix from Aroclor 1254-induced Wistar rats
Test concentrations with justification for top dose:
0,1, 2, 5, 10, 20, 50, 70, 100 mg/plate
Vehicle / solvent:
Vehicle/solvent used: DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
0.2 and 1 µg/plate
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: no
- Exposure duration: 5 days
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: 10E9 cells per ml
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
Number of revertants per plate
Statistics:
Student's t-test

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:
At the highest dose level
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
At the highest dose level
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
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

Acrylamide did not increase the number of reverse mutations in the Ames test at concentrations up to 100 mg/plate either with or without enzymatic activation. Results were consistently negative using Salmonella typhimurium tester strains TA 98, TA 100, TA 102, TA 1535, and TA 1537 in the presence and absence of metabolic activation.