Registration Dossier
Registration Dossier
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EC number: 414-420-0 | CAS number: - SPE 93279
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- 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:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test using the Hprt and xprt genes)
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian cell gene mutation (B17)
Test material
- Reference substance name:
- A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside
- EC Number:
- 414-420-0
- EC Name:
- A mixture of: 2-ethylhexyl mono-D-glucopyranoside; 2-ethylhexyl di-D-glucopyranoside
- Cas Number:
- 125590-73-0
- Molecular formula:
- (C6H10O5)n, C8H18O n = 1,2
- IUPAC Name:
- Reaction mass of 2-ethylhexyl mono-D-glucopyranoside and 2-ethylhexyl di-D-glucopyranoside
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 1000 ... 1700 µg/ml
Concentration range in the main test (without metabolic activation): 1000 ... 1651 µg/ml - Vehicle / solvent:
- Dimethyl sulphoxide
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 3 hours
Exposure period (without metabolic activation): 24 hours
Expression time: Three days
Selection time: Eleven days.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 1750 µg/ml)
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 750 µg/ml)
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 1700 µg/ml)
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
There were no significant or dose dependent increases in the mutant frequency in the absence or in the presence of S9 metabolic activation in independent repeat experiments.
In cultures treated with positive control, mutant frequencies increased significantly in all three experiments. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
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