Phenol, 4-(butoxymethyl)-2-methoxy-

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records

Reference

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:

17.04.2007 - 02.05.2007

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial gene mutation assay

Target gene:

Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Species / strain / cell type:

E. coli WP2 uvr A pKM 101

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Test concentrations with justification for top dose:

Highest concentration for bacteriostatic control: 500 ug/plate; highest concentration for the two other controls and mutagenic assay: 700 ug/plate. Further concentrations: 210, 70, 21 and 7 ug/plate

Vehicle / solvent:

Yes, substance dissolved in DMSO

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

For S. Typhimurium TA 1535, TA 100 without metabolic activation

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

For TFor S. Typhimurium TA 1537 without metabolic activation

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

For S. Typhimurium TA 98 without metabolic activation

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: cis-Platinium (II)

Remarks:

For E. Coli without metabolic activation

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-anthramine

Remarks:

For S. Typhimurium TA 1535, TA 1537, TA 100 and TA 98 with metabolic activation

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9,10-dimethylbenzanthracene

Remarks:

For E. Coli with metabolic activation

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

At the highest concentration (700 ug/plate) has less than 75% cytotoxicity

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'.

Conclusions:

Interpretation of results (migrated information):
negative

In the test conditions, in the presence of the test substance (700 ug, 210 ug, 70 ug, 21 ug and 7 ug/plate), the test substance does not induce any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA99, TA100 and Escherichia coli WP2(uvrA) (pKM 101), without or with metabolic activation according to the OECD Guidelines n°471 and to the method B13/B14 of the directive 2000/32/EC

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)