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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP near-guideline study performed according to scientific standards, published in peer reviewed literature, acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Responses of the L5178Y mouse lymphoma forward mutation assay: V. Gases and vapours.
Author:
McGregor D, Brown AG, Cattanach P, Edwards I, McBride D, Riach C, Shepherd W, Caspary WJ
Year:
1991
Bibliographic source:
Environ. Molec. Mutagen., 17:122-129

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
no
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
1,2 propylene oxide (volatile liquid),
supplied by the National Toxicolgy Programm Chemical Repository, Radian Corporation Austin, TX.

Method

Target gene:
Thymidine Kinase locus
Species / strain
Species / strain / cell type:
mouse lymphoma L5178Y cells
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 (rat liver)
Test concentrations with justification for top dose:
0.04% up to 1.25%
0.63 %-30%
Vehicle / solvent:
- Vehicle(s)/solvent(s) used:none
Controlsopen allclose all
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Remarks:
without S9
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
Remarks:
without S9
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
3-methylcholanthrene
Remarks:
with S9
Evaluation criteria:
Mutation factor was calculated as: MF= 200 x mutant clones per plate (usually as a mean of 3) divided by total clones per plate (usually mean of 3)=
mutants/10E6 clonable cells.
Statistics:
Based upon the mathematical model proposed for this system (Lee and Caspary, 1983) and consited of a dose trend test (Barlow, 1972) and a
variance analysis of pairwise comparison of each dose against the vehicle control.

Results and discussion

Test results
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion