Registration Dossier
Registration Dossier
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EC number: 500-295-0 | CAS number: 106233-09-4 1 - 2.5 moles ethoxylated
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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with CAS 68439-49-6. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.”
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Alcohols, C16-18, ethoxylated
- EC Number:
- 500-212-8
- EC Name:
- Alcohols, C16-18, ethoxylated
- Cas Number:
- 68439-49-6
- IUPAC Name:
- 68439-49-6
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Ethoxylation degree: 1
- Physical state: White waxy solid
- Analytical purity: > 98%
- Lot/batch No.: B 230 N
- Storage condition of test material: No data
Constituent 1
Method
- Target gene:
- n.a.
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- +S9: 313, 625, 1250, 2500, 5000 µg/mL
-S9: 1.25, 2.5, 5, 10, 20, 39, 78 µg/mL - Vehicle / solvent:
- 1% ethanol
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated cells
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 1% ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: methylmethanesulfonate (10-40 µg/mL), cyclophosphamide (20-60 µg/mL)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
- Evaluation criteria:
- According to Guideline.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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