Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methylcrotonic acid
EC Number:
208-782-7
EC Name:
3-methylcrotonic acid
Cas Number:
541-47-9
Molecular formula:
C5H8O2
IUPAC Name:
3-methylbut-2-enoic acid
Test material form:
other: Yellow, cristalline powder
Details on test material:
Purity: 98.7 % , Storage: at 4 °C

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S-9 fraction (Male Sprague Dawley rats)
Test concentrations with justification for top dose:
6 different doses from 4 µg/ plate to 5000 µg/plate.
0,4,20,100,500, 2500, 5000 µg/plate
Preliminary toxicity testswere performed with all test strains using small number of plates to calculate an appropriate dose range.
Vehicle / solvent:
At the day of the experiment the test substance was dissolved with DMSO at the appropriate concentrations.
Controls
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
N-ethyl-N-nitro-N-nitrosoguanidine
benzo(a)pyrene
other: 2-Aminoanthracene
Details on test system and experimental conditions:
Sufficient S-9 fraction is thawed immediately before each test at room temperature. Bacteria are grown overnight in nutrient broth at 37 °C. Male Sprague Dawley rats (200-300g) received a single intraperitoneal injection of Aroclor 1254 (500 mg/kg bw) 5 days before sacrafice.

Results and discussion

Additional information on results:
Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies.

Applicant's summary and conclusion

Conclusions:
Mutagenicity: In the absence of the metabolic activation system the test compound did not show a dose dependend increase in number of revertants in any of the bacterial strains. Also in the presence of the metabolic system, treatment of the cells did not show an increase in the number of revertant colonies. 3-Methylcrotonic acid is not mutagenic.