Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
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
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Lime Oxide
IUPAC Name:
Lime Oxide
Constituent 2
Reference substance name:
1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized
EC Number:
277-225-8
EC Name:
1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized
Cas Number:
73018-51-6
IUPAC Name:
1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized
Constituent 3
Reference substance name:
Reaction mass of (E)-5-(but-2-en-2-yl)-2,2-dimethyltetrahydrofuran and 1-isopropyl-4-methylcyclohexa-1,3-diene and 1-isopropyl-4-methylcyclohexa-1,4-diene and 1-methyl-4-(propan-2-ylidene)cyclohex-1-ene
IUPAC Name:
Reaction mass of (E)-5-(but-2-en-2-yl)-2,2-dimethyltetrahydrofuran and 1-isopropyl-4-methylcyclohexa-1,3-diene and 1-isopropyl-4-methylcyclohexa-1,4-diene and 1-methyl-4-(propan-2-ylidene)cyclohex-1-ene
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Lime Oxide
- Molecular formula: predominantly a mixture of monoterpenes C10H16 and cyclic monoterpene ethers C10H18O
- Molecular weight: monoterpenes C10H16 molecular weight 136.2, cyclic monoterpene ethers C10H18O molecular weight 154.2
- Physical state: clear colorless liquid
- Analytical purity: 61.8%, sum of 4 major peaks
- Impurities: Known impurities are similar in nature to the major components and have empirical formulae of either C10H16 or C10H18O
- Lot/batch No.: SC00009577
- Expiration date of the lot/batch: 13 October 2015
- Storage condition of test material: room temperature, in the dark
Specific details on test material used for the study:
Batch: 9000475443
Liquid

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Phenobarbitine and Beta Naphthoflavone
Test concentrations with justification for top dose:
Experiment 1: 33, 100, 333, 1000, 2500 and 5000 ug/plate.
Experiment 2: 10, 33, 100, 333, 1000 and 2500 ug/plate.
Base on bactericidal affects.
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
sodium azide
methylmethanesulfonate
other: 2-Aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION:
in agar (plate incorporation); preincubation.

DURATION
- Exposure duration:3 days

SELECTION AGENT (mutation assays): Histidine and Biotin

NUMBER OF REPLICATIONS: 3

Rationale for test conditions:
Assess the potential of the test item to induce gene mutations.
Evaluation criteria:
A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshol of twice (TA98, TA100, TA102) of thrise (TA1535, TA1537) the colony count of the corresponding solvent control observed.
Statistics:
None

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
In conclusion, it can be stated that during the mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshift in the genome of the strains used.
Executive summary:

Negative Ames test in the absence and presence of S9-mix in stains TA1535, TA1537, TA98, TA100 and TA102..