1,3,4,5-tetrahydroxycyclohexanecarboxylic acid

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

With the Ames test the genotoxicity of quinic acid was determined. For the two Salmonella typhimurium strains TA 100 and TA 98 tested with and without metabolic activation no mutations were found. From this result it can be concluded, that quinic acid is not genotoxic.

Link to relevant study records

Reference

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: Study is not done according to OECD guideline. But it is a well documented study.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Experimental treatments consisted of adding to a tube in the indicated order 0.1 ml of an overnight culture of the bacterial tester strain; 0.5 ml of phosphate-buffered saline (PBS, pH 7.4) or a standard S9 liver microsomal mixture (prepared as in Ames et al. (1975): 100 µl liver supernatant/ml mix) and 0.4 ml of the test sample dissolved in PBS. The treatment suspensions were then incubated at 37°C in a shaker-water bath for a 20-min duration. At this time, 2.0 ml of molten top agar (45°C) containing minimal histidine was added to each tube and the mixture was overlaid on minimal glucose agar plates (Ames et al., 1975). A minimum of 2 replicate tubes were prepared per sample dilution. All plates were incubated at 37°C for 2days. The number of histidine prototrophs on each plate was scored by using an Artek automatic colony counter.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

rat liver microsomal Aroclor 1254

Test concentrations with justification for top dose:

0 mg/plate, 162 mg/plate and 203 mg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: PBS (phosphate-buffered saline pH 7.4)

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

PBS

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

benzo(a)pyrene

Remarks:

Sodium azide and benzo(a)pyrene for TA100 and 2-nitrofluorene for TA98

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 2 days
- Exposure duration: 20 min

NUMBER OF REPLICATIONS: minimum 2 replicated tubes

Species / strain:

other: S. typhimurium TA 98, TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: strain/cell type: S. typhimurium TA 98, TA 100

Remarks:

Migrated from field 'Test system'.

Compound	Concentration (mg/plate)	His+ revertant colonies/plate Strain TA100		His+ revertant colonies/plate Strain TA98
		-S9	+S9	-S9	+S9
Quinic acid	203	116	110	Toxic	32
	162	140	131	26	35
	0	129	122	32	31

Controls:

TA100 sodium azide (5 µg/plate): 1329 revertans/plate

TA100 benzo(a)pyrene (10 µg/plate): -S9 122 revertants/plate; +S9 613 revertants/plate

TA98 2-nitrofluorene (5 µg/plate): 646 revertants/plate

Conclusions:

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

The genetic toxicity of quinic acid was determined using the Ames test with and without metabolic activation. For the two Salmonella typhimurium strains TA 98 and TA 100 no mutations were detected.

Executive summary:

In the publication of Stich et al., 1981, quinic acid was tested in the Ames test with the two Salmonella typhimurium strains TA 100 and TA 98 with and without metabolic activation. No mutation was found for any tested strain. Therefore, we consider that quinic acid is not genotoxic.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

In the publication of Stich et al., 1981, quinic acid was tested in the Ames test with the two Salmonella typhimurium strains TA 100 and TA 98 with and without metabolic activation. No mutation was found for any tested strain. Therefore, we consider that quinic acid is not genotoxic.

Justification for selection of genetic toxicity endpoint

Study is not done according to OECD guideline. But it is a well documented study.

Justification for classification or non-classification

The results of the Ames test of quinic acid were negative. Therefore, we can conclude that quinic acid has no mutagenic effects and does not need to be classified.