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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientific and detailed study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
his, tryp
Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9 (Arcoclor 1254 induced)
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9 (Arcoclor 1254 induced)
Test concentrations with justification for top dose:
0.033, 0.1, 0.33, 1, 3.33 and 5 mg
Controls
Negative controls:
no
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
benzo(a)pyrene

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
other: a minimum of three non-toxic doses were required to evaluate assay data.
Vehicle controls valid:
yes
Negative controls valid:
not examined
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

The results of the Salmonella-Escherichia coZi/Mammalian-Microsome Reverse Mutation Assay
with a Confirmatory Assay indicate that under the conditions of this study, Roche Colorado
Corporation’s test article, Ro 40-8168/002 (PE Salt), did not cause a positive increase in the mean
number of revertants per plate with any of the tester strains either in the presence or absence of
microsomal enzymes prepared from AroclorTM-induced rat liver (S9).
Executive summary:

Under the conditions of the study, Ro 40-8168/002 did not cause a positive increase in the number of

revertants per plate in any of the tester strains either in the presence or absence of metabolic activation.

Based on these results, it can be concluded that neither Ro 40-8168/002 THL-PE Salt per se, nor any of the formed

metabolites is mutagenic in the Ames test under the described experimental conditions.