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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
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is comparable to OECD 471 with acceptable restrictions (not tested in TA 1535; no data about purity of the test substance or cytotoxic effects)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
(TA1535 not tested)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
BATCH: N2B
DATE OF PRODUCTION: 04.11.2008
no further details

Method

Target gene:
His-
Species / strain
Species / strain / cell type:
other: TA97a, TA98, TA100, TA102
Metabolic activation:
with and without
Metabolic activation system:
S9-mix of male rats treated with 500 mg/kg bw Delor103 five days prior to sacrifice
Test concentrations with justification for top dose:
The substance was applied directly to the petri dish in the following amounts: 0, 5, 10, 20, 40, 80 µL
Vehicle / solvent:
water
Controls
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminofluorene with S)-mix & furylfuramid without S9-mix
Details on test system and experimental conditions:
The substance in quantities of 0.1 ml with 2 - 4 x 10E7 fresh cells of each strain was added to sterile tubes with 2 ml of top agar with histidine and biotin. In tests with metabolic activation, 0.5 ml of metabolic activation mixture was added to each tube. The content of the tube poured onto the surface of glucose minimal medium, deposited on a Petri dish (PD). Petri dishes were incubated at 37 ° C for 48-72 hours. Subsequently, his + revertant colonies were counted. Tests were repeated three times at each concentration on two parallel Petri dishes
Evaluation criteria:
statistical significance
Statistics:
The observed values were statistically evaluated by a system of one-dimensional data set (Student t - test): the arithmetic mean, standard deviation and statistical significance.

Results and discussion

Test results
Species / strain:
S. typhimurium, other:
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Authors conclusion: "The test substance did not show statistically significant increase in revertants in the Ames test, depending on the doses - concentration used. The negative response in the experiments show that in the test conditions Phenol does not have mutagenic properties to the target indicator Salmonella typhimurium."

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Negative results in the Ames test with and without metabolic activation even at very high concentrations up to 80 µL/plate