Registration Dossier
Registration Dossier
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EC number: 500-075-4 | CAS number: 31694-55-0 1 - 6.5 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in accordance to GLP and OECD guideline 473.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Glycerol, propoxylated
- IUPAC Name:
- Glycerol, propoxylated
- Reference substance name:
- 25791-96-2
- Cas Number:
- 25791-96-2
- IUPAC Name:
- 25791-96-2
- Reference substance name:
- Glycerol, propoxylated
- EC Number:
- 500-044-5
- EC Name:
- Glycerol, propoxylated
- IUPAC Name:
- 500-044-5
- Reference substance name:
- alpha, alpha', alpha''-1,2,3-propanetriyltris[w-hydroxypoly(oxy-(methyl-1,2-ethanediyl)]
- IUPAC Name:
- alpha, alpha', alpha''-1,2,3-propanetriyltris[w-hydroxypoly(oxy-(methyl-1,2-ethanediyl)]
- Details on test material:
- - Name of test material (as cited in study report): Voranol CP 260
- Analytical purity: >99%
- Lot/batch No.: TA18083021
- Storage condition of test material: Room Temperature under nitrogen over silica in the dark.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Method
- Target gene:
- Not Applicable
- Statistics:
- The frequency of cells with abberrations excluding gaps and the frequency of polypoid cells was compared where necessary with the concurrent vehicle control value using Fisher's Exact test.
Results and discussion
Test results
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material was considered to be non-clastogenic to human lymphocytes under the conditions tested.
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