Cyperus scariosus, ext.

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test:

Cyperus scariosus, ext (CAS no 91771-62-9) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation. 

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:

weight of evidence approach based on structurally similar chemicals

Justification for type of information:

Weight of evidence approach based on structurally similar chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

AMES salmonella/microsome mutagenesis assay

Principles of method if other than guideline:

WoE based on two in-vitro gene toxicity studies1 In – vitro Bacterial reverse mutation assay of test chemical in S. typhimurium 2. In – vitro Bacterial reverse mutation assay of test chemical in S. typhimurium

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium, other: TA 98 and 100, UTH8414 and UTH8413

Remarks:

1

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium, other: TA1535, TA1537, TA1538, TA98, TA100

Remarks:

2.

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

Rat liver microsome fraction S9 from Aroclor induced male

Test concentrations with justification for top dose:

1. 10-1000 ug/plate 2. 25000 ug/plate

Vehicle / solvent:

1. DMSO

Untreated negative controls:

not specified

Remarks:

1.

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

sodium azide

other: cisplatin (10 ug/plate) was the positive control for UTH8414 and UTH 8413 without S9. 2-Aminoanthracene (10 ug/plate) was the positive control for TA98 with S9.

Details on test system and experimental conditions:

1. METHOD OF APPLICATION: in agar (plate incorporation)DURATION- Preincubation period:- Exposure duration: 48 hours 2. METHOD OF APPLICATION: in agar (plate incorporation)DURATION- Preincubation period:- Exposure duration: two days

Evaluation criteria:

1. Number of colonies per plate were counted. 2. Revertant colonies were counted.

Species / strain:

S. typhimurium, other: TA 98 and 100, UTH8414 and UTH8413

Remarks:

1.

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

S. typhimurium, other: TA1535, TA1537, TA1538, TA98, TA100

Remarks:

2.

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: Non mutaginc

Conclusions:

Cyperus scariosus, ext (CAS no 91771-62-9) does not exhibit gene mutation in vitro.

Executive summary:

Ames test:

Study 1:

Gene toxicity test was performed to determine the mutagenic nature of test chemical. The study was performed using Salmonella Typhimurium TA 98 and 100, UTH8414 and UTH8413 both in the presence and absence of mammalian S-9 microsomal fraction. The test material did not induce reverse mutations. Therefore, Test chemical did not induce mutation in Salmonella Typhimurium TA 98 and 100, UTH8414 and UTH8413 with and without mammalian S-9 microsomal fraction. Hence it is not likely to classify as a gene mutant in vitro.

 Study 2:

Gene toxicity test was performed to determine the mutagenic nature oftest chemical. The study was performed usingS. typhimurium TA1535, TA1537, TA1538, TA98, TA100in the presence of mammalian S-9 microsomal fraction. The test material did not induce reverse mutations. Therefore,Test chemical did not induce mutation inSalmonella TyphimuriumS. typhimurium TA1535, TA1537, TA1538, TA98, TA100 with mammalian S-9 microsomal fraction.Hence it is not likely to classify as a gene mutant in vitro.

Based on the data available from the read across, Cyperus scariosus, ext (CAS no 91771-62-9) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation. 

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

Data available for target and the read across chemicals was reviewed to determine the in- vitro gene toxicity of Cyperus scariosus, ext (CAS no 91771-62-9). The studies are as mentioned below:

Ames test:

Study 1:

Gene toxicity test was performed to determine the mutagenic nature of test chemical. The study was performed using Salmonella Typhimurium TA 98 and 100, UTH8414 and UTH8413 both in the presence and absence of mammalian S-9 microsomal fraction. The test material did not induce reverse mutations. Therefore, Test chemical did not induce mutation in Salmonella Typhimurium TA 98 and 100, UTH8414 and UTH8413 with and without mammalian S-9 microsomal fraction. Hence it is not likely to classify as a gene mutant in vitro.

 Study 2:

Gene toxicity test was performed to determine the mutagenic nature oftest chemical. The study was performed usingS. typhimurium TA1535, TA1537, TA1538, TA98, TA100in the presence of mammalian S-9 microsomal fraction. The test material did not induce reverse mutations. Therefore,Test chemical did not induce mutation inSalmonella TyphimuriumS. typhimurium TA1535, TA1537, TA1538, TA98, TA100 with mammalian S-9 microsomal fraction.Hence it is not likely to classify as a gene mutant in vitro.

Based on the data available from the read across, Cyperus scariosus, ext (CAS no 91771-62-9) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation. 

Justification for classification or non-classification

Based on the data available from the read across, Cyperus scariosus, ext (CAS no 91771-62-9) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.