Guaiacol

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The purity of the test substance was known. The authors cited the Ames et al. (1975) methods paper with a detailed protocol following the cited procedure. The results were described in details.

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity testing in the Salmonella typhimurium assay of phenolic compounds and phenolic fractions obtained from smokehouse smoke condensates

Author:

Pool B.L., Lin P.Z.

Year:

1982

Bibliographic source:

Food and Chemical Toxicology, 20, 383-391.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Guaiacol

EC Number:

201-964-7

EC Name:

Guaiacol

Cas Number:

90-05-1

Molecular formula:

C7H8O2

IUPAC Name:

Phenol

Details on test material:

Guaiacol was purchased from Kluka, Buchs and was 98% pure or of analytical grade.

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 pre-treated Sprague-Dawley rats.

Test concentrations with justification for top dose:

0, 0.5, 5, 50, 500, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: see details below

Details on test system and experimental conditions:

POSITIVE CONTROL(S) SUBSTANCE:
2-Nitrofluorene: 3 µg/plate for TA 98 and TA 1538 without metabolic activation
Sodium azide: 2 µg/plate for TA 1535 and TA 100 without metabolic activation
9-Aminoacridine: 60 µg/plate for TA 1537 without metabolic activation
2-Aminoanthracene: 5 µg/plate for all strains with metabolic activation

DETAILS ON TEST SYSTEM AND CONDITIONS:
S. Typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100 were kindly supplied by Prof. B.N. Ames (University of Berkeley, Calif., USA).
The test for their reversion to histidine prototrophy was performed using the plate incorporation assay as previously described (Ames, McCann & Yamasaki, 1975). Each compound was dissolved in DMSO and tested in 5 concentrations in the presence of buffer ph 7.4 or S9 mix.

METHOD OF APPLICATION: in agar (plate incorporation)
Exposure duration: 48 hours

Evaluation criteria:

The number of histidine revertants were scored and compared to the number of spontaneously arising revertants.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

the concentration of 5000 µg/plate resulted in toxicity which was apparent as a thinning of the background lawn.

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'.

Any other information on results incl. tables

Table of results:

	Concentration [µg/plate]	No. of revertants per plate	No. of revertants per plate	Cytotoxicity
				(yes/no)
		— MA	+ MA
TA 100	0	67	76	no
	0,5	66	94	no
	5	71	93	no
	50	65	81	no
	500	67	95	no
	5000	57	64	no
	Sodium azide / 2-Aminoanthracene	502	723	no
TA 1535	0	24	9	no
	0,5	21	16	no
	5	26	13	no
	50	22	19	no
	500	15	16	no
	5000	25	9	no
	Sodium azide / 2-Aminoanthracene	526	306	no
TA 1537	0	5	14	no
	0,5	7	12	no
	5	7	16	no
	50	4	13	no
	500	4	9	no
	5000	0	13	yes (-S9)
	9-Aminoacridine / 2-Aminoanthracene	810	269	no
TA 98	0	19	19	no
	0,5	20	34	no
	5	18	36	no
	50	23	14	no
	500	22	16	no
	5000	16	5	yes (+S9)
	2-Nitrofluorene/ 2-Aminoanthracene	275	1093	no
TA 1538	0	5	10	no
	0,5	13	12	no
	5	9	11	no
	50	10	11	no
	500	14	9	no
	5000	13	10	no
	2-Nitrofluorene/ 2-Aminoanthracene	284	1027	no

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and without metabolic activation

- INTERPRETATION OF RESULTS:
Regarding results and applying actual criteria evaluation, the test item presented no mutagenic activity with and without S9 mix in
Salmonella Typhimurium in all strains.
Reproductibility between the experiment and positive control results in accordance with positive criteria, validated the study.

Executive summary:

In a reverse gene mutation assay in bacteria (Pool et al., 1982), strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 of S. typhimurium were exposed to guaiacol at concentrations of 0 to 5000 µg/plate in the presence and absence of mammalian metabolic activation.

Guaiacol was tested up to cytotoxic concentrations and was negative.

Cytotoxicity was observed at 5000 µg/plate.

The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.