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Toxicological information

Genetic toxicity: in vivo

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Administrative data

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

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2003
Report date:
2013

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
mouse
Strain:
CD-1
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified

Administration / exposure

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
Doses / concentrations
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

Results and discussion

Test results
Key result
Sex:
not specified
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

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.