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
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.13, 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, 102, 1535, 1537; esc WP2 uvrA
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 312.5 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 312.5 ... 5000 µg/plate
Vehicle / solvent:
Solvent: Destillieres Wasser
Details on test system and experimental conditions:
Metabolic activation system: Das Gemisch S9 (S9-Mix) wurde aus einer post-mitochondrialen
Fraktion aus Lebern der Ratten, die mit Aroclor 1254
vorbehandelt wurden, vorbereitet.

"ENGLISH"

The S9 mix was prepared from a post-mitochondrial fraction
from livers of the rats which were pretreated with aroclor
1254.

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:
Kein Niederschlag wurde bei den geprüften Dosierungsstufen
bemerkt.

"ENGLISH"

No precipitation was observed at the tested dose levels.
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
positive without metabolic activation