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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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
No details on the concentrations used

Data source

Reference
Reference Type:
publication
Title:
Inhibition of Metabolic Cooperation in Chinese Hamster V79 Cells by Various Organic Solvents and Simple Compounds
Author:
Chen TH, et al.
Year:
1984
Bibliographic source:
Cell Biol. Toxicol. 1 (1):155- 171

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method described in Trosko et al., 1984 (In Handbook of Carcinogen Testing) is based on metabolic cooperation between 6-thioguanine sensitive (HGPRT+) cells and 6-thioguanine resistant (HGPRT-) cells in vitro.
GLP compliance:
no
Type of assay:
in vitro mammalian cell gene mutation test using the Hprt and xprt genes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Details on mammalian cell type (if applicable):
- Type and identity of media: Modified Eagle's medium
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data
Additional strain / cell type characteristics:
other: with and without HGPRT deficiency
Metabolic activation:
without
Test concentrations with justification for top dose:
not indicated
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 12-tetra-decanoyl-1-phorbol-13-acetate (TPA)

Results and discussion

Test results
Key result
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion