Registration Dossier

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:
March 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD and GLP guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: 92/69/EWG, B.13, B.14 (Ames-Test)
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: sat TA 98, 100, 102, 1535, 1537, 1538; esc WP2 uvrA pKM102
Metabolic activation:
with and without
Metabolic activation system:
S9-Mix aus Rattenleber, Aroclor 1254-induziert "ENGLISH" S9 mix from rat liver, Aroclor 1254-induced
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 5 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 5 ... 5000 µg/plate
Vehicle / solvent:
Solvent: DMSO
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 500 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>= 5000 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>= 5000 µg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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

The mutagenic potential of PCH-3 -phenol was tested in an Ames test. The test substance showed no mutagenic potential with and without metabolic activation.