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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9 mixture
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
mitomycin C
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Conclusions:
From the overall results, it was concluded that Cyanogen Bromide did not induce any mutation and considered as NON-MUTAGENIC upto the concentration of 4.88 μg/plate, under the test conditions employed.
Executive summary:

The mutagenic effect of Cyanogen Bromide Sponsored by Libor Bachura vyzkum a vyroba, Czech Republic, was evaluated by Ames Salmonella typhimurium - Reverse mutation assay. This study was conducted as per the OECD Guideline No. 471, Adopted 21st July, 1997 at Bioscience Research Foundation, India.

The five tester strains (TA98, TA100, TA102, TA1535 and TA1537) were assessed to be intact. The test substance was dissolved in Distilled water. During precipitation test, no precipitation was observed even at the highest concentration of 5000 μg / plate in the top agar mix.

In the range finding study, two tester strains TA98 and TA100 was selected for cytotoxic analysis. Preincubation method was followed and seven test concentrations along with the solvent control (Distilled water) were treated both in the presence and absence of metabolic activation (S9 mix). Based on the precipitation test, the following concentrations were selected viz., 78.13, 156.25, 312.5, 625, 1250, 2500 and 5000 μg / plate (separated by factor 2 spacing). There was no contamination found in the control and the treated test concentrations. Duplicate culture was set for all test concentrations. Intact background lawn was observed in the concentration of 78.13 μg/plate in +S9 and –S9 of both TA 98 and TA 100 strains. The background lawn of the controls of both tester strains were found to be intact. In TA 98 Extreme inhibition was observed in test concentration 625, 1250, 2500 and 5000 μg/plate in both +S9 and –S9. Moreover, TA 100 extreme inhibition was observed test concentrations 312.5, 625, 1250, 2500 and 5000 μg/plate in both the +S9 and –S9. The revertant colonies of cultures were not comparable to the solvent control in both the strains with the presence and absence of S9 mix.

Based on the range finding results, the mutagenic effect was tested in the main study. Five tester strains (TA98, TA100, TA102, TA1535 and TA1537) were tested in preincubation method followed by plate incorporation method. Five concentrations 4.88, 9.76, 19.53, 39.06 and 78.13μg/plate in the presence and absence of S9 mix along with the solvent and concurrent positive controls were treated. Triplicate cultures were set for all the test concentrations.

There was no contamination found in the controls and the test concentrations treated. Intact background lawn was observed in all the test concentrations and the control plates in the presence and absence of S9 mix in all the five tester strains. The revertant colonies of the solvent controls in all the tester strains are comparable to the historical control values. In the treated cultures, the revertant colonies are comparable to the solvent control in all the strains except TA 102 in which concentration related increase in the revertant colonies was observed at the concentration of 9.76 and 19.53 μg/plate. On the contrary, 4.88 μg/plate was comparable with that solvent control. The results obtained from preincubation method were identical in plate incorporation method. The strain specific positive controls with the presence and absence of S9 mix exhibited multifold increase of the revertant colonies over the solvent control tested in both the preincubation and plate incorporation method.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification