Indigofera tinctoria, ext.

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Under in vitro conditions Indigofera tinctoria did generally not induce gene mutations in bacteria nor in mammalian cells. In one gene mutation test inbacteria with limited value due to a bad performance of the test an induction of the number of revertants was observed. This positive finding was considered not biologically relevant. Indigofera tinctoria induced an increase in the number of cells with chromosome aberrations in one chromosome aberration test with limited value whereas in a well performed test it was not genotoxic.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

other: SCCS opinion 1439/11

Adequacy of study:

key study

Study period:

20 December 2005 – 24 April 2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1997

Deviations:

not specified

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

Content of the main active ingredient Indican (indoxyl-β-D-glucosid): 3.56% (HPLC) respectively 2.01% after autoclaving

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium TA 102

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

0, 3, 10, 33, 100, 333, 1000, 2500 and 5000 g/plate, without and with S9-mix

Vehicle / solvent:

DMSO

Untreated negative controls:

yes

Negative solvent / vehicle controls:

other: according to OECD guideline

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

not specified

Details on test system and experimental conditions:

experiment 1: direct plate incorporation with at least 48 h incubation,without and with S9-mix
experiment 2: pre-incubation method with 60 minutes pre-incubation and at least 48 h incubation, without and with S9-mix

Rationale for test conditions:

not specified

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

not determinable

Conclusions:

Under the experimental conditions used Indigofera tinctoria was not genotoxic (mutagenic) in this gene mutation tests in bacteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

Indigofera tinctoria exposure of mice did not result in an increase in erythrocytes with micronuclei. Indigofera tinctoria leaf powder is not genotoxic in vivo.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

SCCS Comment:

Consequently based on the present reports Indigofera tinctoria can be considered to have

no in vivo genotoxic potential and additional tests are unnecessary.

Justification for classification or non-classification

Not classified.

Under in vitro conditions Indigofera tinctoria did generally not induce gene mutations in bacteria nor in mammalian cells.

The positive finding in the single in vitro chromosome aberration test was not confirmed in a well performed in vivo experiment. Indigofera tinctoria exposure of mice did not result in an increase in erythrocytes with micronuclei.