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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: NTP study, performed following official guideline. No GLP reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Principles of method if other than guideline:
Standard NTP protocol. See below for further information
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
No data
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9
Vehicle / solvent:
Acetone
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Acetone

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

 

Strain: TA100

S9 Activation

S9 Species

Concentration

No Activation

N/A

N/A

30% RLI

Rat

30%

30% HLI

Hamster

30%

10% RLI

Rat

10%

10% HLI

Hamster

10%

 

Strain: TA1535

S9 Activation

S9 Species

Concentration

No Activation

N/A

N/A

30% RLI

Rat

30%

30% HLI

Hamster

30%

10% RLI

Rat

10%

10% HLI

Hamster

10%

 

Strain: TA97

S9 Activation

S9 Species

Concentration

No Activation

N/A

N/A

30% RLI

Rat

30%

30% HLI

Hamster

30%

10% RLI

Rat

10%

10% HLI

Hamster

10%

 

Strain: TA98

S9 Activation

S9 Species

Concentration

No Activation

N/A

N/A

30% RLI

Rat

30%

30% HLI

Hamster

30%

10% RLI

Rat

10%

10% HLI

Hamster

10%

 

Concentration denotes the the percentage of S9 in the S9 mixture (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) that was added to cultures

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative