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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 11 - October 6, 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

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

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9 liver microsomal fraction from male Sprague Dawley rats
Test concentrations with justification for top dose:
A preliminary toxicity test was performed on strain TA98 without metabolic activation. The following concentrations were tested : 0. 005 - 0. 01 -0.05 - 0.1 - 0.5 - 1 - 5 mg/plate. As the concentration of 5 mg/plate
was very toxic and 1 mg/plate affected the bacterial lawn, the following range was adopted for the definitive study : 0. 01 - 0. 05 - 0.1 - 0. 5 - 1 mg/plate.
Vehicle / solvent:
Acetone
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
ethylmethanesulphonate
methylmethanesulfonate

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium, other: TA 100, TA 1535, TA1537, TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Values obtained in the presence of test article was greater than twice the value obtained with the solvent control on strain TA 98.

Applicant's summary and conclusion

Conclusions:
PNCl2 is mutagenic on strain TA 98, with and without metabolic activation, not mutagenic on the others strains.
The mutagenic potency of test compound decreases in presence of metabolic activation.

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