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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Chemical structure
Reference substance name:
2,2'-dimethyl-2,2'-azodipropiononitrile
EC Number:
201-132-3
EC Name:
2,2'-dimethyl-2,2'-azodipropiononitrile
Cas Number:
78-67-1
Molecular formula:
C8H12N4
IUPAC Name:
2,2'-dimethyl-2,2'-azodipropiononitrile
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.