2-Butene, 1,1,4,4-tetramethoxy-

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:

14.9. - 04.10.1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: According to guideline under GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not applicable

GLP compliance:

yes

Remarks:

statement of compliance

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

C4-diacetale

IUPAC Name:

C4-diacetale

Details on test material:

- Name of test material (as cited in study report): c4-diacetale
- Analytical purity: 97.5%
- Storage condition of test material: RT

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 97, 98, 100, 102

Details on mammalian cell type (if applicable):

- Properly maintained: yes

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

33 - 5000 ug/plate

Results and discussion

Test results

Species / strain:

other: TA97, TA98, TA100, TA102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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

C4-Diacetal (Ro 94-0101), precursor of beta carotene and astaxanthin synthesis,
shows borderline mutagenic activity in strain TA100. No mutagenic potential was
detected in the other three investigated Salmonella tester strains TA97, TA98
and TA102.

Executive summary:

C4-Diacetal (Ro 94-0101), a precursor of beta carotene and astaxanthin synthesis,

was evaluated for mutagenic activity in the Salmonella/mammalian microsome

assay (Ames test). Four strains (TA97, TA98, TA100 and TA102) were employed

with and without exogenous metabolic activation system (S9-mix). Positive

controls were performed in parallel to each experiment verifying the

sensitivity of the strains and the activity of the metabolic activation

system.

Ro 94-0101 was diluted in dimethylsulfoxide (DMSO) and tested up to 5'000

pg/plate, the recommended maximum test concentration for non toxic substances.

No precipitation of the compound after the addition to the aqueous medium was

observed. Toxic effects were apparent at 5'000 pg/plate without S9, except for

strain TA98, in the standard plate incorporation assay.

Ro 94-0101 induced a weak increase of the number of revertants at dose levels

around 1'000 to 5'000 pg/plate in strain TA100, whereas the other three

strains did not indicate a mutagenic potential of the test compound.

Thus it can be concluded, that Ro 94-0101 shows borderline mutagenic activity

in strain TA100 in the high dose range (> 1'000 ug/plate).