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Diss Factsheets

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:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Literature data

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity of cosmetics ingredients licensed by the European Communities
Author:
Gocke E., King M.-T., Eckhardt K. and Wild D.
Year:
1981
Bibliographic source:
Mutation Research, 90 (1981) 91-109

Materials and methods

Principles of method if other than guideline:
In the Ames assay, at least 5 doses, usually up to 3600 µg/plate for non-toxic and soluble compounds, were tested in all 5 strains with and without activation by the S9 liver fraction from Aroclor-pretreated rats.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01

Method

Species / strain
Species / strain / cell type:
other: S. typhimurium TA1538, TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
- Supplier: Dr. B.N. Ames, University of California, Berkeley, CA (U.S.A.).
Metabolic activation:
with and without
Metabolic activation system:
S9 liver fraction from Aroclor-pretreated rats.
Test concentrations with justification for top dose:
Up to 3600 µg/plate
Details on test system and experimental conditions:
2 slightly different minimal media: one (in the following named ZLM medium) is a modified minimal medium for E. coli and the other is the Vogel-Bonner (VB) medium.
ZLM medium contained (in g/L):
tri-Nacitrate x 2H20: 0.82
K2HPO4 x 3H20: 4.60
KH2PO 4: 1.50
(NH4)2SO4: 1.00
MgSO4 x 7H20: 0.10
glucose: 17.0.
The concentration of citrate was 3.5 times higher in VB medium than in ZLM medium.
The concentrations of the other ions are up to 2-fold higher in VB medium.
Statistics:
Significance was calculated according to the Kastenbaum-Bowman tables

Results and discussion

Test results
Species / strain:
other:
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results:
negative

Non-mutagen
Executive summary:

As part of an investigation into mutagenic effects of environmental compounds, three systems were used to evaluate the genetic toxicity of substances: the Sahnonella/microsome test, the Basc test on Drosophila and the micronucleus test on mouse bone marrow.

Result

Non-mutagen