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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04/09/2002 - 14/02/2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to guidline under GLP
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Principles of method if other than guideline:
not relevant
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4-amino-2-methylpyrimidine-5-methylamine
EC Number:
202-384-7
EC Name:
4-amino-2-methylpyrimidine-5-methylamine
Cas Number:
95-02-3
Molecular formula:
C6H10N4
IUPAC Name:
5-(aminomethyl)-2-methylpyrimidin-4-amine
Details on test material:
- Name of test material (as cited in study report): Grewe-diamine

Method

Target gene:
TA97a: hisD6610, TA 98: hisD3052; TA 100 and TA 1535 hisG46, TA102: hisG428
Species / strain
Species / strain / cell type:
other: TA97a, TA 98; TA 100, TA 1535, TA102
Details on mammalian cell type (if applicable):
not applicable
Additional strain / cell type characteristics:
other: TA97a, TA98 and TA100: uvrB; TA100 & 102: pKM 101 (TA97a, TA98, TA100 and TA 102 are rfa)
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
5, 1.5, 0.5, 0.15, 0.005 mg/ plate
Controls
Untreated negative controls:
yes
Remarks:
pure solvent
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
Migrated to IUCLID6: Aminoanthracene, NaN3

Results and discussion

Test results
Species / strain:
other: TA97a, TA 98; TA 100, TA 1535, TA102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

no additional remarks

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Grewe-diamin can be considered as not mutagenic and not cytotoxic in the Ames test under the described experimental conditions.
Executive summary:

Grewe-diamin was evaluated for mutagenic activity in the Ames test. A standard plate incorporation and a preincubation modification assay in absence and in presence of an exogenous metabolic activation system (S9) were performed. Five Salmonella typhimurium

tester strains (TA1535, TA97a, TA98, TA100, and TA102) were employed. The activity of the S9 -mix and the responsiveness of the tester strains were verified by including appropriate controls into each experiment. The substance was dissolved in water. Five different concentrations up to 5 mg/plate were chosen for the main experiment.

No significant increase in the number of revertant colonies was apparent in all five tester strains (TA1535, TA97a, TA98, TA100, and TA102) using both methods, after treatment with Grewe-diamin.

Based on these data Grewe-diamin can be considered as not mutagenic and not cytotoxic in the Ames test under the described experimental conditions.