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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Studies conducted to recognised testing guidelines with GLP certification.

Link to relevant study records

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Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 liver homogeneate fraction
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 5 ... 500 µg/plate
Concentration range in the main test (without metabolic activation): 5 ... 500 µg/plate
Vehicle / solvent:
Solvent: DMSO
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 500 µg/plate.
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 5000 µg/plate)
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 500 µg/plate)
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 5000 µg/plate)
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 500 µg/plate)
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 5000 µg/plate)
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 500 µg/plate)
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 5000 µg/plate)
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 500 µg/plate)
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 5000 µg/plate)
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 500 µg/plate)
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 5000 µg/plate)
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
(> 500 µg/plate)
Additional information on results:
Observations:
At the concentration range investigated, ESACURE 1001 did not show any mutagenic activity with or without the addition of S9 liver homogeneate fraction.
Conclusions:
Interpretation of results (migrated information):
- Negative with metabolic activation
- Negative without metabolic activation
Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to
Guideline:
EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Metabolic activation system:
S9 tissue homogenate with protein content ca.37.1 mg/ml and Aminopyrine demethylase activity (uM/g liver/5 min, formadeyde production) ca.3.89
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 25 ... 100 µg/ml
Concentration range in the main test (without metabolic activation): 25 ... 100 µg/ml
Vehicle / solvent:
DMSO
Details on test system and experimental conditions:
Exposure period (with metabolic activation): 3 hours
Exposure period (without metabolic activation): 20 hours
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
other: >= 100 µg/ml
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
other: >= 25 µg/ml
Additional information on results:
Observations:
No statistically significant increase in the incidence of cells bearing aberrations including and excluding gaps, compared with the relevant control values, was observed at any dose level selected for the scoring in the absence or presence of S9 metabolism.

The positive controls Cyclophoshamide and Mitomycin-C shown a statistically significant increase of aberrant cells confirmed the correct functioning of the assay system.
Conclusions:
Interpretation of results (migrated information):
- Negative with metabolic activation
- Negative without metabolic activation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification