2,5-xylenol

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:

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

Test material information

Constituent 1

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