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Toxicological information

Genetic toxicity: in vitro

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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:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material as cited in study report: Fatty alcohol ethyleneglycolether (C16-18, alcohol, ethoxylated)
- Ethoxylation degree: 1
- Physical state: Waxy, slightly yellowish
- Analytical purity: > 98%
- Lot/batch No.: B 230 N
- Storage condition of test material: At ambient temperature.

Method

Target gene:
HPRT locus
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:
dose finding test: 0, 1 - 100 µg/mL (solubility limit)
main test: 0, 1.8, 6, 18, 60, 100 µg/mL
Vehicle / solvent:
H0 medium with 1% ethanol
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
H0 medium with 1% ethanol
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: ethylmethanesulfonate (300 µg/mL), 3-methylcholanthrene (10 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:
not examined
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