Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
2-methylpropan-1-ol /Isobutyl alcohol/ is both reagents used in the manufacture of Reaction mass of 2-methylpropan-1-ol and sodium O-isobutyl dithiocarbonate and sodium hydroxide . Therefore, 2-methylpropan-1-ol /Isobutyl alcohol/ need to be considered in the assessment of Reaction mass of 2-methylpropan-1-ol and sodium O-isobutyl dithiocarbonate and sodium hydroxide

Data source

Reference
Reference Type:
publication
Title:
Evaluation of the genotoxic potential of some microbial volatile organic compounds (MVOC) with the comet assay, the micronucleus assay and the HPRT gene mutation assay
Author:
Kreja L, Seidel H-J
Year:
2002
Bibliographic source:
Mutation Research 513: 143-150

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Principles of method if other than guideline:
Clastogenic effects were studied by the micronucleus test using the Chinese hamster V79 cell line as a target.
GLP compliance:
not specified
Type of assay:
in vitro mammalian cell micronucleus test

Test material

Constituent 1
Chemical structure
Reference substance name:
disodium 2-methylpropan-1-ol [(2-methylpropoxy)methanethioyl]sulfanide hydroxide
EC Number:
904-290-8
Cas Number:
25306-75-6
Molecular formula:
C5H10OS2.Na
IUPAC Name:
disodium 2-methylpropan-1-ol [(2-methylpropoxy)methanethioyl]sulfanide hydroxide
Test material form:
solid: compact
Details on test material:
2-methylpropan-1-ol /Isobutyl alcohol/ is both reagents used in the manufacture of Reaction mass of 2-methylpropan-1-ol and sodium O-isobutyl dithiocarbonate and sodium hydroxide . Therefore, 2-methylpropan-1-ol /Isobutyl alcohol/ need to be considered in the assessment of Reaction mass of 2-methylpropan-1-ol and sodium O-isobutyl dithiocarbonate and sodium hydroxide
- Name of test material (as cited in study report): 2-Methylpropan-1-ol
- Analytical purity: Highest commercially available (typically >99%), from Riedel de Haen

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Details on mammalian cell type (if applicable):
- Type and identity of media: MEM Eagle medium (V79 cells) supplemented with 10% heat-inactivated fetal calf serum (FCS), 2 mM L-glutamine,
100 IU/ml penicillin and streptomycin.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data
Metabolic activation:
without
Test concentrations with justification for top dose:
11 and 53 mM
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: [no data]
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium


DURATION
- Exposure duration: 4 hours at 37 °C
- Expression time (cells in growth medium): additional 24 hours


NUMBER OF CELLS EVALUATED: 1000 cells/culture


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
The test compound was classified as a clastogen when it was able to enhance the spontaneous MN frequency at least three-fold or higher over that of the control for at least one dose tested.
Statistics:
no data

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No mutagenic activity of Isobutyl Alcohol detected.Isobutyl Alcohol is both reagents used in the manufacture, as well as decomposition products of Sodium isobutyl xanthate. Therefore, the health effects of Isobutyl Alcohol need to be considered in the assessment of sodium isobutyl xanthate. In addition, xanthates decompose on aging to form a number of byproducts, depending on the pH, temperature, etc. Risks associated with xanthate are, therefore, a function of the breakdown of the product or un-reacted raw materials remaining in the product.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results:negative

No mutagenic activity of Isobutyl Alcohol detected. 2-methylpropan-1-ol /Isobutyl alcohol/ is both reagents used in the manufacture of Reaction mass of 2-methylpropan-1-ol and sodium O-isobutyl dithiocarbonate and sodium hydroxide . Therefore, 2-methylpropan-1-ol /Isobutyl alcohol/ need to be considered in the assessment of Reaction mass of 2-methylpropan-1-ol and sodium O-isobutyl dithiocarbonate and sodium hydroxide