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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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions, limited documentation

Data source

Reference
Reference Type:
publication
Title:
SCREENING OF TOBACCO SMOKE CONSTITUENTS FOR MUTAGENICITY USING THE AMES' TEST
Author:
Florin, I.
Year:
1980
Bibliographic source:
Toxicology, 16 (1980) 219-232

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Only 4 strains of S. typhimurium and no E. coli strain were tested Test design in accordance with B.N. Ames, J. McCann and E. Yamasaki, Mutat. Res., 31 (1975) 347.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2,5-xylenol
EC Number:
202-461-5
EC Name:
2,5-xylenol
Cas Number:
95-87-4
Molecular formula:
C8H10O
IUPAC Name:
2,5-dimethylphenol
Test material form:
not specified
Details on test material:
no data

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-Mix from Aroclor 1254 or 3-methylcholantrene induced rats
Test concentrations with justification for top dose:
The subctance was tested at 3 µmol/plate.
Vehicle / solvent:
Ethanol was used as vehicle
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
other: 2-aminoanthracene (with metabolic activation)
Remarks:
N-ethyl-N-nitro-N-nitrosoguanidine used without metabolic activation
Details on test system and experimental conditions:
The experiments were carried out essentially as described by Ames (1975) and using the spot test.

The substance was tested at 3 μmol/plate. In absence of a background lawn of bacteria on the plates ( indicating toxicity) the test would have been repeated with a lower concentration of the substance.

The following controls were made :
- the viable count was determined;
- the number of spontaneous revertants was measured;
- the presence of the rfa-mutation was checked by crystal violet inhibition;
- the presence of the plasmid pKM 101 in strains TA 98 and TA 100 was checked by resistance to ampicillin;
- the response to the positive controls N-methylN'-nitroN-nitrosoguanidin (not requiring metabolic activation) and 2-aminoanthracene (requiring activation) was checked
Evaluation criteria:
Not decribed by the authors.
Statistics:
No statistics were performed.

Results and discussion

Test results
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:
no cytotoxicity
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