Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain:
S. typhimurium TA 98
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 rat liver
Species / strain:
S. typhimurium TA 100
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 rat liver
Vehicle:
Not specified, but unchanged phosgene was detected in the incubation medium by GC analysis only above a gaseous concentration of 10,000 ppm.
Statistics:
Not specified, although data points in graphs have brackets to indicate variability.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Additional information on results:
Phosgene is non-mutagenic under the conditions of the S. typhimurium test system, because it
reacts rapidly in the test medium. We detected unchanged phosgene in the solution only above a
gaseous concentration of 10,000 ppm.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
other: immeasurable

Phosgene would not be mutagenic under the conditions of liquid suspension in the Ames assay,
because this volatile gas reacts rapidly and completely with the components of the incubation
system. This does not allow measurable exposure concentrations of phosgene to be attained in
the test system. Thus, the extreme reactivity and toxicity of phosgene obviates the feasibility of
further genetic toxicity testing.