Reaction mass of 6-butyl-3,6-dihydro-2,4-dimethyl-2H-pyran and 2-butyl-3,6-dihydro-4,6-dimethyl-2H-pyran and 2-butyltetrahydro-6-methyl-4-methylene-2H-pyran

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Key study Examination of Gyrane ST. 2 for mutagenic activity in the Ames test dated on December 1985 and perfomed at Division for nutrition and food research TNO according to the OECD guideline 471 (1983 version).

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

.

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

no TA102 strains used

Principles of method if other than guideline:

As OECD 471 (1983) required to test Salmonella typhimurium TA1535, TA1537, TA98 and TA100 only, there is no deviation from the guideline.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

Material Identification (as stated in the report) : Gyrane St. 2
Sample received on 2nd, December 1985
Dilutions of the test substance were made with ethanol just prior to use.

Target gene:

- Salmonella typhimurium TA1535, TA1537, TA98 and TA100

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

Rat liver S9-mix induced by Aroclor 1254

Test concentrations with justification for top dose:

Preliminary test with TA98, without S9-mix: 8.5, 85, 850, 8500 and 85000 µg/plate

Main study: TA1535, TA1537, TA1538, TA98 and TA100:
Without and with S9-mix: 10.49, 31.48, 94.44, 283.33 and 850 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Dilutions of the test substance were made with ethanol just prior to use.

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

Positive controls:

yes

Positive control substance:

other: 2-nitrofluorene 1.0 µg/plate in DMSO for TA98 and TA1538

Remarks:

without S9

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

Positive controls:

yes

Positive control substance:

other: Sodium azide 1.0 µg/plate in water for TA1535 and TA100

Remarks:

without S9

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

Positive controls:

yes

Positive control substance:

other: 9-aminoacridine 80 µg/plate in DMSO for TA1537

Remarks:

without S9

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene 2.0 µg/plate in DMSO for all tester strains

Remarks:

with S9

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at the highest dose level µg/plate without S9 only

Vehicle controls validity:

valid

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium, other: TA1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

At 850 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Conclusions:

From the above findings it is concluded that Gyrane St 2. did not show any mutagenic activity in the Salmonella/mammalian microsome mutagenicity test under the conditions employed in this evaluation.

Executive summary:

The genetic toxicity of Gyrane was assessed at toxic concentrations of ≤ 850 µg/plate using S. typhimurium TA100, TA1535, TA98, TA1537 and TA1538 strains, in accordance with OECD 471 guideline and according to GLP principles. All strains showed cytotoxicity at the highest tested concentrations.

All bacterial strains showed negative responses with and without metabolic activation. Based on the results of this study, the substance Gyrane is not mutagenic in the Salmonella typhimurium reverse mutation assay.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Justification for classification or non-classification

The genetic toxicity of Gyrane was assessed at toxic concentrations of ≤ 850 µg/plate using S. typhimurium TA100, TA1535, TA98, TA1537 and TA1538 strains, in accordance with OECD 471 guideline and according to GLP principles. All strains showed cytotoxicity at the highest tested concentrations.

All bacterial strains showed negative responses with and without metabolic activation. Based on the results of this study, the substance Gyrane is not mutagenic in the Salmonella typhimurium reverse mutation assay.