Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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

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).

Categories Display