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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.14 (Ames-Test); OECD 471
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain / cell type:
bacteria, other: sat TA 98, 100, 1535, 1537
Metabolic activation system:
Aroclor 1254 induzierter Rattenleber S9-Mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 100 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 100 ... 5000 µg/plate
Vehicle / solvent:
Solvent: Dimethylsulfoxid (DMSO)

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Additional information on results:
Observations:
Ohne metabolische Aktivierung zeigten alle 4 Stämme über den
gesamten Prüfbereich keinen dosisabhängigen Anstieg der Zahl
der Revertant-Zellen. Gleiches gilt auch für TA 1535 mit
metabolischer Aktivierung.

Mit metabolischer Aktivierung zeigen die Stämme TA 1537,

TA 98 und TA 100 einen deutlichen dosisbezogenen Anstieg der
Zahl der Revertant-Kolonien.

"ENGLISH"

Without metabolic activation, none of the four strains
exhibited any dose-dependent increase in the number of
revertant cells throughout the entire test period. The same
also applies to TA 1535 with metabolic activation.

With metabolic activation, the strains TA 1537, TA 98 and TA
100 revealed a clear dose-dependent increase in the number
of revertant colonies.
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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