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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Only 4 strains used. Less positive controls.
Principles of method if other than guideline:
Method according to Ames, B.N. et al.: Mutat. Res. 31, 347-364
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
2,2'-azobisisobutyronitrile; no data on purity of the compound
Specific details on test material used for the study:
common name: Porofor N, Pt. 23091979

Method

Target gene:
his
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver microsomes
Test concentrations with justification for top dose:
20; 100; 500; 2,500; 12,500 ug/plate
Vehicle / solvent:
- DMSO for Porofor N, Trypaflavin and 2-aminoanthracene
- deion. water for Endoxan
Controls
Untreated negative controls:
other: vehicle control
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Endoxan (Cyclophosphamid); Trypaflavin; 2-Aminoanthracene.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Remarks:
at 12,500 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Since precipitation of the test substance was observed at 12,500 µg/plate, this dose level could not be evaluated.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative

Based on the results of this study, the test substance Porofor N does not need to be classified according to EC/1272/2008 and 67/548/EEC.