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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
no
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyloxirane
EC Number:
200-879-2
EC Name:
Methyloxirane
Cas Number:
75-56-9
Molecular formula:
C3H6O
IUPAC Name:
2-methyloxirane
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