Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene toxicity in-vitro:

The test result was considered to be negative in the presence and absence of metabolic activation for the test substance .Hence the substance cannot be classified as genetox in vitro

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Experimental data of structurally similar chemicals
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar chemicals
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
WoE report is based on two in vitro gene toxicity studies
1.To evaluate the mutagenic potential of test chemical in Salmonella typhimurium TA98, TA100, TA1535, TA1537, and TA1538.
2. To evaluate the mutagenic potential of test chemical in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 by Salmonella microsome assay.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Target gene:
1.& 2. Histidine
Species / strain / cell type:
S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538.
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium, other: strains TA1535, TA100, TA1537, TA1538 and TA98 bacteria
Remarks:
2
Details on mammalian cell type (if applicable):
Not applicable.
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
Liver S9 homogenate was prepared from male Sprague-Dawley rats and Syrian golden hamsters that had been injected with Aroclor 1254 at 500 mg/kg body weight.
Test concentrations with justification for top dose:
1.of 10-10000 µg /plate
2. 0,50,100and 500μg/plate
Vehicle / solvent:
1. - Vehicle(s)/solvent(s) used: Not specified
2. - Vehicle(s)/solvent(s) used: DMSO
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
not specified
Untreated negative controls:
yes
Remarks:
Historical value provided for comparison.
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Ethylmethanesulfonate Methylmethanesulfonate 9-Aminoacridine Anthragallol 2-Anthramine
Remarks:
2
Details on test system and experimental conditions:
1. METHOD OF APPLICATION: Plate incorporation method
2. METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period:
- Exposure duration: 3 days
Rationale for test conditions:
Not specified.
Evaluation criteria:
1. A positive result in the Ames test, which is defined as a reproducible, dose-related, at least twofold increase in the number of revertants over background was not observed with any of the azo dyes or their metabolites either before or after incubation with S-9.
2. Number of HIS + Revertants/plate were observed for test substance and compared with positive and negative control.
Statistics:
1. Standard deviation was observed.
2.Rounded mean _+ standard deviation was observed.
Species / strain:
S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538.
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium, other: strains TA1535, TA100, TA1537, TA1538 and TA98 bacteria
Remarks:
2.
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:
valid
Additional information on results:
2. COMPARISON WITH HISTORICAL CONTROL DATA: Historical Negative control values were compared with the test substance value.
Remarks on result:
other: No mutagenic effect were observed
Conclusions:
The test result was considered to be negative in the presence and absence of metabolic activation for test substance.
Executive summary:

Data available for the target chemical was reviewed to determine the mutagenic nature of the test chemical .The studies are as mentioned below:

The mutagenic potency of test chemicalwas tested by the plate incorporation method usingSalmonella typhimuriumstrainTA98, TA100, TA1535, TA1537, and TA1538. When the test bacterial strain is exposed with the test chemical for 48hrs, no mutagenic response was seen in any of the strains of Salmonella typhimurium(with and without metabolic activation system).Therefore the test substance was considered to be not classified for gene mutation.

Test chemical was assessed for its possible mutagenic potential. For this purpose bacterial reverse mutation assay was performed on Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98. The test material was exposed at the concentration of 0, 50,100and 500µg/plate in the presence and absence of S9 mix. Number of HIS + Revertants/plate was observed for test substance and compared with positive and negative control. No mutagenic effect were observed in any of the strain, both in the presence and absence of S9.Therefore, test chemical was considered to be non mutagenic in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 by bacterial reverse mutation assay. Hence the substance cannot be classified as gene mutant in vitro.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Gene toxicity in-vitro:

Gene mutation in vitro:

Data available for the target chemical was reviewed to determine the mutagenic nature of the test chemical .The studies are as mentioned below:

Ames test:

The mutagenic potency of test chemicalwas tested by the plate incorporation method usingSalmonella typhimuriumstrainTA98, TA100, TA1535, TA1537, and TA1538. When the test bacterial strain is exposed with the test chemical for 48hrs, no mutagenic response was seen in any of the strains of Salmonella typhimurium(with and without metabolic activation system).Therefore the test substance was considered to be not classified for gene mutation.

Test chemical was assessed for its possible mutagenic potential. For this purpose bacterial reverse mutation assay was performed on Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98. The test material was exposed at the concentration of 0, 50,100and 500µg/plate in the presence and absence of S9 mix. Number of HIS + Revertants/plate was observed for test substance and compared with positive and negative control. No mutagenic effect were observed in any of the strain, both in the presence and absence of S9.Therefore, test chemical was considered to be non mutagenic in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 by bacterial reverse mutation assay. Hence the substance cannot be classified as gene mutant in vitro.

Based on the data available from the test chemical does not exhibit gene toxicity in in the presence and absence of metabolic activation.. Hence the substance cannot be classified as genetox in vitro.

Justification for classification or non-classification

Based on the data available from the test chemical and CLP criteria test chemical does not exhibit gene toxicity in in the presence and absence of metabolic activation.. Hence the substance cannot be classified as genetox in vitro.