Reaction mass of 2-methylpropan-1-ol and sodium O-isobutyl dithiocarbonate and sodium hydroxide

Genetic toxicity: in vitro

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:

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

Reference

Name:

Unnamed

Type:

Constituent

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