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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant, similar to guideline study, available as unpublished report, adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-Dimethyl-1H-pyrazole
EC Number:
600-813-6
Cas Number:
1072-68-0
Molecular formula:
C5H8N2
IUPAC Name:
1,4-Dimethyl-1H-pyrazole
Details on test material:
- Name of test material (as cited in study report): 1,4-dimethylpyrazole
- Lot No.: DP9001
- Purity: 99.3%
- Appearance: colorless/light yellow liquid
- Storage: the test substance was stored in a cold, dark place in a test substance storage room

Method

Target gene:
- S. typhimurium: His-locus
- E.coli: Trp-locus
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Liver S9 fraction of phenobarbitone and ß-naphthoflavone induced rats
Test concentrations with justification for top dose:
Pre-test: 100, 500, 1000, 2000, 5000 µg/plate
Main test: 313, 625, 1250, 2500, 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: distilled water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide; 2-Methoxy-6-chloro-9-(3-(2-chloroethyl)-amionpropylamino)acridine 2HCl; 2-aminoanthracene
Remarks:
With metabolic activation: 2-AA (all strains); Without metabolic activation: 2-(2-Furyl)3-(5-nitro-2-furyl)acrylamide (TA 98, TA 100, WPr2 uvrA), sodium azide (TA 1535), 2-Methoxy-6-chloro-9-(3-(2-chloroethyl)-amionpropylamino)acridine 2HCl (TA 1537)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION : Exposure duration: 48 hours

NUMBER OF REPLICATIONS: 2 test plates per dose or control

DETERMINATION OF CYTOTOXICITY: growth inhibition
Evaluation criteria:
The main test was valid when the sterility test confirmed the absence of bacterial contamination and when the number of revertant colonies both for the solvent and positive controls was within the range of the background data. Then, the test substance was judged positive when the number of revertant colonies (mean value of two plates) was more than twice that of the solvent control and dose-related. When judgement the reproducibility for the test result was confirmed between a range-finding test and a main test.

Results and discussion

Test resultsopen allclose all
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
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
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