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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Lawsonia Inermis (Henna) is not genotoxic in gene mutation tests in bacteria. All these studies are performed according to GLP. Two of these studies are performed according to the OECD guideline 471 and 476.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
other: SCCS /1511/13
Adequacy of study:
key study
Study period:
11.9.1990-15.10.1990
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:
1983
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 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
50, 100, 500, 1000, 2500 and 5000 μg/plate with and without metabolic activation
Vehicle / solvent:
DMSO
Untreated negative controls:
yes
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
not specified
Remarks:
Appropriate negative and po sitive controls were included.
Key result
Species / strain:
S. typhimurium TA 1535
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 TA 1537
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 TA 98
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 TA 100
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 TA 1538
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
Conclusions:
No bacteriotoxic effect was observed. Henna Rot did not induce an increase in revertants in the bacterial strains in the tested concentration range between 50 to 5000 μg/plate. The sensitivity and validity of the test system used was demonstrated by the significant induction of revertants by the positive controls. Under the experimental conditions used, Henna Rot was not mutagenic in this gene mutation tests in bacteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Link to relevant study records
Reference
Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
other: Mutation Research, 2003
Adequacy of study:
key study
Study period:
na
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Version / remarks:
1997
GLP compliance:
yes
Type of assay:
mammalian bone marrow chromosome aberration test
Species:
mouse
Strain:
CD-1
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified
Route of administration:
intraperitoneal
Vehicle:
Methylcellulose. Positive control; Vehicle was water
Details on exposure:
300mg/kg
Duration of treatment / exposure:
not specified
Frequency of treatment:
once
Dose / conc.:
300 mg/kg diet
No. of animals per sex per dose:
not specified
Control animals:
yes
Positive control(s):
cyclophosphamide (CPA) 50 mg/kg
Key result
Sex:
not specified
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Conclusions:
The results of a further mouse bone marrow MN test with Henna containing HNQ did not indicate an increase in MN frequency at any dose, even though bone marrow toxicity was induced.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Active substance, Lawsone, has a complex toxicity and genetic toxicity profile. It was haematotoxic in an oral subchronic rodent study and positive or borderline-positive in the mouse lymphoma assay and a chromose aberration test in CHO cells, but negative in Salmonella, a CHO-HRPT test and a SHE assay (Kirkland and Marzin, 2003). On the basis of these data, Lawsone, was considered to have getoxic potential in vivo. A non-genotoxic mechanism was supported by the results of an addional micronucleus test, which confirmed haematotoxicity 72h after a single oral dose of Lawsone, and a 24- and 72 h bone marrow chromosome aberration study in mice all of which had negative results. Kirkland and Marzin 2003).

In the literature we found some reported cases which have some indication of positive genotoxic potential and even SCCS reported further consideration on this endpoint is desirable.

Justification for classification or non-classification