Registration Dossier
Registration Dossier
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EC number: 700-291-0 | CAS number: 1000701-92-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD 471 + GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-hexyloxyethanol
- EC Number:
- 203-951-1
- EC Name:
- 2-hexyloxyethanol
- Cas Number:
- 112-25-4
- Molecular formula:
- C8H18O2
- IUPAC Name:
- 2-(hexyloxy)ethanol
- Reference substance name:
- Hexylglycol (EGHE)
- IUPAC Name:
- Hexylglycol (EGHE)
- Details on test material:
- purity > 99.2%
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 20 μg - 5 000 μg/plate (Standard Plate Test)
312.5 μg - 5 000 μg/plate (Preincubation Test) - Vehicle / solvent:
- DMSO
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 2500 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- NEGATIVE
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
According to the results of the present study, the test substance did not lead to an increase in
the number of revertant colonies either without S9 mix or after adding a metabolizing system
in two experiments carried out independently of each other (standard plate test and
preincubation assay).
Besides, the results of the negative as well as the positive controls performed in parallel
corroborated the validity of this study, since the values fulfilled the acceptance criteria of this
study.
In this study with and without S9 mix, the number of revertant colonies in the negative
controls was within the range of the historical negative control data for each tester strain.
In addition, the positive control substances both with and without S9 mix induced a significant
increase in the number of revertant colonies within the range of the historical positive control
data or above
Applicant's summary and conclusion
- Conclusions:
- negative
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