3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane

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: GLP guideline sudy - only 4 strains tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

The mutagenic potential of Vulkazon AFS/LG was examined in the Salmonella/microsome test. Bacteria of four histidine auxotrophic Salmonella typhimurium LT2 mutant strains (TA 98, TA 100, TA 1535, and TA 1537) were exposed to doses up to 5000 µg per plate.

GLP compliance:

yes

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane

EC Number:

229-542-8

EC Name:

3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane

Cas Number:

6600-31-3

Molecular formula:

C19H28O4

IUPAC Name:

3,9-bis(cyclohex-3-en-1-yl)-2,4,8,10-tetraoxaspiro[5.5]undecane

Test material form:

other: granules

Details on test material:

IUCLID4 Test substance: other TS: purity 91.3 %
Test Substance
name of
test substance : Vulkazon AFSILG
manufacturer: BAYER AG
content: 91.3% (analytical result)
appearance: brownish granules
storage: refrigerator
chemical name: Pentaerythrite-tetrahydrobenzaldehydeacetal
molecular weight : 320.4 g/mole
molecular formula: C19 H28O4

Method

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

other: Firstly, they are deep rough since certain lipopolysaccharide side chains are missing in the bacterial cell wall. Secondly, their reduced ability to repair damage from UV light (e.g. thymidine dimers) allows the phenotypic detection of mutation events

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

up to 5000 ug/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

other: nitrofurantoin, 4-nitro-1,2-phenylene diamine, 2-aminoanthracene

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:

other: The substance revealed weak, strain-specific bacteriotoxic effects at higher doses yet doses up to 5000 µg per plate could still be used for assessment purposes

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

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

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Doses up to and including 8 µg per plate did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no growth inhibition was observed. The substance revealed weak, strain-specific bacteriotoxic effects at higher doses yet doses up to 5000 µg per plate could still be used for assessment purposes. Substance precipitation occurred at the dose of 5000 µg per plate yet all plates could be used for assessment purposes.

There was no evidence for mutagenic effects of Vulkazon AFS/LG. A biologically relevant increase of the mutant count over control levels was not observed.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

The mutagenic potential of Vulkazon AFS/LG was examined in the Salmonella/microsome test. Bacteria of four histidine auxotrophic Salmonella typhimurium LT2 mutant strains (TA 98, TA 100, TA 1535, and TA 1537) were exposed to doses up to 5000 µg per plate.

Doses up to and including 8 µg per plate did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no growth inhibition was observed. The substance revealed weak, strain-specific bacteriotoxic effects at higher doses yet doses up to 5000 µg per plate could still be used for assessment purposes. Substance precipitation occurred at the dose of 5000 µg per plate yet all plates could be used for assessment purposes.

There was no evidence for mutagenic effects of Vulkazon AFS/LG. A biologically relevant increase of the mutant count over control levels was not observed.Therefore, Vulkazon AFS/LG was negative with and without S9 mix in the Salmonella/microsome test.