Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study was not performed according a specific guideline (e.g. no batch number or purity of the test substance is given and no independent repeated was performed) and it is not clear whether the study is performed according GLP principles. However, the conclusion is considered reliable and supported by a weight of evidence from analogue substance (P-93 and Alcamizer 5).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Principles of method if other than guideline:
No specific quideline mentioned in the document.
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name (IUPAC): Hydrotalcite-like compound
Name (Usage, trade, etc.): DHT
Chemical formula: Mg3. 5~4. 5Al2(OH)1 1~1 3*CO3 2.5~3.5H2O

Method

Target gene:
Base-pair substitutions:
TA100, TA1535, WP2uvrA

Frameshift:
TA98, TA1537, TA1538
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9mix
Test concentrations with justification for top dose:
10, 50, 100, 500, 1000 en 5000 ug/plate
Vehicle / solvent:
Solvent control.
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Positive controls:
yes
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Positive controls:
yes
Positive control substance:
9-aminoacridine

Results and discussion

Test results
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Negative