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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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study but no information on GLP

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity testing in the Salmonella Typhimurium assay of phenolic compounds and phenolic fractions obtained from smokehouse smoke condensates
Author:
Pool BL and Lin PZ
Year:
1982
Bibliographic source:
Food Chem Toxicol 20: 383-391

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Principles of method if other than guideline:
In an Ames test p-cresol was tested for mutagenicity at five concentrations up to 500µg/plate with and without S-9 mix using five strains of S. typhimurium.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: p-cresol, purity : 98 %

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with and without
Metabolic activation system:
a 9000 xg supernatant from Sprague-Dawley rat liver pretreated with Aroclor 1254
Test concentrations with justification for top dose:
0, 0.5, 5, 50, 500, 5000 ug/plate dissolved in DMSO, highest dose cytotoxic
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Sodium azide, 2-Nitrofluorene, 9-Amino-acridine, 2-Aminoanthracene
Details on test system and experimental conditions:
IUCLID4 Type: Ames test, plate incorporation methodology
Evaluation criteria:
a dose-related significantly increased number of revertants was evaluated as a positive result.
Statistics:
Joncheere test

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: 5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
no further data
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

p-cresol yielded a negative result in the Ames test performed according to OECD TG 471 in the presence and in the absence of a metabolic activation system.

Positive controls were functional

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
Executive summary:

p-cresol yielded a negative result in the Ames test performed according to OECD TG 471 in the presence and in the absence of a metabolic activation system.