Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
The following information concerning identity and composition of the test item was pro-vided by the sponsor.
Name Methyl Cyclopentenolone
Batch no. D270001706002
Appearance white, crystal powder
Composition Methyl Cyclopentenolone
Purity >99.0%
Homogeneity homogeneous
Expiry date 07. Jun. 2018
Storage Room Temperature (20 ± 5°C)

The following additional information was relevant to the conduct of the study, according to
OECD 471:

CAS No. 80-71-7
EINECS-No. 201-303-2
Stability H2O: unknown; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Solubility H2O: < 0,1 g/L; EtOH: >1 g/L; acetone: >1 g/L; CH3CN: >1 g/l; DMSO: >1 g/l

Method

Species / strain
Species / strain / cell type:
other: TA97a TA98 TA100 TA102 TA1535
Test concentrations with justification for top dose:
5000 µg/plate
Vehicle / solvent:
Acetone
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Details on test system and experimental conditions:
All Salmonella typhimurium strains were obtained from TRINOVA BioChem GmbH (batch: TA97a: 4997D, TA98: 5011D, TA100: 4996D, TA102: 4982D, TA1535: 5012D) and were stored as lyophilizates in the refrigerator at 2-8 °C.
The lyophilizates were used to prepare permanent cultures which were filled into vials and stored at < - 75 °C.

Eight hours before the start of each experiment, an aliquot of a permanent culture per strain to be used was taken from the deep freezer to inoculate a culture vessel containing nutrient broth. After incubation overnight for eight hours at 37 ± 1 °C, the cultures were used in the experiment. During the test, the cultures were stored at room temperature as to prevent changes in the titre.

Results and discussion

Test results
Key result
Species / strain:
other: TA97a, TA98, TA100, TA102 and TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion