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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:
weight of evidence
Study period:
21. to 24 Nov. 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted according to internaltional guideline and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Androst-4-ene-3,17-dione
EC Number:
200-554-5
EC Name:
Androst-4-ene-3,17-dione
Cas Number:
63-05-8
Molecular formula:
C19H26O2
IUPAC Name:
androst-4-ene-3,17-dione

Method

Target gene:
Histidine locus
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 98, TA 102 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9 microsomal fraction
Test concentrations with justification for top dose:
up to 5.0 mg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Remarks:
untreated
Positive controls:
yes
Positive control substance:
other: - S9 Mix: Sodium azide: TA100, TA 1535; 4-NOPD: TA 1537, TA 98; MMS: TA 102; + S9 Mix: 2-AA all strains

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98, TA 102 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
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'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Based on the results for the read-across test substance, testosterone is not classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).
Executive summary:

Test data are available for genetic toxicity of testosterone indicates negative genetic toxicity. Additional data available on the structurally similar compound (androstenedione, ZK5155) are reported here as supporting data.

ZK 5155 (androstenedione) did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurim strains TA98, TA1537, TA100, TA102, TA1535) when tested up to the highest recommended dose level of 5.0 mg/plate in the absence or presence of extrinsic metabolic activation (liver S9 mix from Aroclor 1254 -treated rats).