Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
genetic toxicity in vitro
Remarks:
Type of genotoxicity: other: gene and genome mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
no data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Abstract

Data source

Reference
Reference Type:
publication
Title:
A comparative study on selected chemical carcinogens for chromosome malsegregation, mitotic crossing-over and forward mutation induction in Aspergillus nidulans.
Author:
Crebelli, R., Bellincampi, D., Conti, G., Conti, L., Morpurgo, G., Carere, A.
Year:
1986
Bibliographic source:
Mutat Res. 1986 Nov;172(2):139-49.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Type of assay:
other: Forward mutations (methionine suppressors), mitotic crossing-over and chromosome malsegregation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Thiourea
- Analytical purity: > 99%

Method

Target gene:
no data
Species / strain
Species / strain / cell type:
other: Aspergillus nidulans
Details on mammalian cell type (if applicable):
no data
Additional strain / cell type characteristics:
not specified
Metabolic activation:
without
Metabolic activation system:
n.a.
Test concentrations with justification for top dose:
65.7 and 197.1 mM (equal to 5 and 15 mg/ml)
Vehicle / solvent:
no data
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
no data
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Species / strain:
other: Aspergillus nidulans
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
no data
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Thiourea did not induce forward mutations and chromosome malsegregation in Aspergillus nidulans. In this study thiourea is not considered to have mutagenic potential.
Executive summary:

The genotoxicitiy of thiourea was tested in Aspergillus nidulans at concentration of 5 and 15 mg/ml. Forward mutations (methionine suppressors), mitotic crossing-over and chromosome malsegregation were the end-points scored. Thiourea did not induce genotoxic effects despite being tested at cytotoxic concentration.