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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06/1982 - 07/1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: good test description available, no GLP oder OECD guidlines followed

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4-amino-2-methylpyrimidine-5-carbonitrile
EC Number:
211-814-2
EC Name:
4-amino-2-methylpyrimidine-5-carbonitrile
Cas Number:
698-29-3
Molecular formula:
C6H6N4
IUPAC Name:
4-amino-2-methylpyrimidine-5-carbonitrile

Method

Target gene:
all 5 strains contain the deep rough (rfa) mutation, which deletes the polysaccharide side chain of the lipopolysaccharide coat of the bacterial cell surface
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Additional strain / cell type characteristics:
other: mutations in the histidine operon. TA 1538 was used intead of TA 1535
Metabolic activation:
with and without
Metabolic activation system:
mixed function oxidase system
Test concentrations with justification for top dose:
5, 50, 500 and 5000 ug/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
yes
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
Migrated to IUCLID6: 9-aminoacridine, N-ethyl-N-nitro-N-nitroso-guanidine, 2-aminoanthracene, benzo-(a)pyrene, 2- (2-furyl)-3- (5- nitro-2-fury1 acrylamide

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not specified
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

it is concluded that Pynitril itself nor its metabolites produced by rat liver enzymes are mutagenic under the conditions emploid.
Executive summary:

the Ames test with Pynitril was performed in 1980 according to the (at that time) state of the art practices. None of the revertant colonies increased over the back ground (negative control) in the dose range from 5 to 5000 pg/plate with or without metabolic activation by a rat liver homogenate (S-9 Mix.).

On the other hand, positive control compounds were clearly mutagenic under the conditions employed