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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Strain to detect cross-linking mutagens missing, but acceptable at time of study, analytical purity of test substance not specified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Strain to detect cross-linking mutagens missing
GLP compliance:
no
Remarks:
not invented yet at the time of the study
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Acrawax C. Prills 52-383 753171
- Analytical purity: No data

Method

Target gene:
His-operon (S. typhimurium), ade/trp-loci (S. cerevisiae)
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
Species / strain / cell type:
Saccharomyces cerevisiae
Details on mammalian cell type (if applicable):
D4
Metabolic activation:
with and without
Metabolic activation system:
Liver S9 fraction of Aroclor 1254-pretreated rats
Test concentrations with justification for top dose:
0.1, 1.0, 10.0, 100.0, 500.0 and 1000.0 µg/plate without activation; 0.1, 1.0, 10.0, 100.0 and 500.0 µg/plate with activation
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water, dimethylsulfoxid (DMSO)
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Dimethylsulfoxide (DMSO)
True negative controls:
no
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
Remarks:
TA1535, TA100, D4 without S9

Migrated to IUCLID6: 10 µL/plate
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Dimethylsulfoxide (DMSO)
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: QM, 10 µg/plate
Remarks:
TA1537 without S9
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Dimethylsulfoxide (DMSO)
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
TA1538, TA98 without S9
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-anthramin, 2.5 µg/plate
Remarks:
TA1535, TA1537, TA1538, TA98, TA 100 with S9
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Dimethylsulfoxide (DMSO)
True negative controls:
no
Positive controls:
yes
Positive control substance:
N-dimethylnitrosamine
Remarks:
D4 with S9

Migrated to IUCLID6: 100 µmol/plate
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h for TA-1535, TA-1537, TA 1538, TA-98, TA-100; 3-5 d for D4

DETERMINATION OF CYTOTOXICITY
- Method: other: direct revertant colony counts


Evaluation criteria:
Strains TA-1535, TA-1537, and TA-1538: If the solvent control value is within the normal range, a chemical that produces a positive dose-response over three concentrations with the lowest increase equal to twice the solvent control value is considered to be mutagenic.
Strains TA-98, TA-100, and D4: If the solvent control value is within the normal range, a chemical that produces a positive dose response over three
concentrations with the highest increase equal to twice the solvent control value for TA-100 and 2-3 times the solvent control value for strains TA-98 and D4 is considered to be mutagenic. For these strains, the dose-response increase should start at approximately the solvent control value.

If a chemical produces a response in a single test that cannot be reproduced in one or more additional runs, the initial positive test data lose significance.
Statistics:
no data

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:
Slightly toxic to TA 1537 at 500 µg per plate.
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:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
Saccharomyces cerevisiae
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
ADDITIONAL INFORMATION ON CYTOTOXICITY: The compound was slightly toxic to the strain T-1537 at 500 µg per plate.
TA-98 was repeated at 100, 500 and 1000 µg because of the increased number of revertants at 500 µg over the background level. The repeat test was negative.

Any other information on results incl. tables

The test compound, Acrawax C. Prills 52-383 753171, did not demonstrate mutagenic activity in any of the assays conducted in this

evaluation and was considered not mutagenic under these test conditions.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative