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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
publication
Title:
Arsenic and smokeless tobacco induce genotoxicity, sperm abnormality as well as oxidative stress in mice in vivo
Author:
Das, S. et al.
Year:
2016
Bibliographic source:
Genes and Environment 38:4
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: No guideline was followed
GLP compliance:
not specified
Type of assay:
mammalian bone marrow chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Sodium arsenite (CAS 7784-46-5)

Test animals

Species:
mouse
Strain:
Balb/c
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Pasteur Institute, Shillong, Meghalaya, India
- Age at study initiation: 10–12 weeks
- Weight at study initiation: 20–25 g body weight
- Assigned to test groups randomly: yes, n = 6, 3 males and 3 females in each group
- Diet (e.g. ad libitum): Amrut Laboratory Animal Feeds, New Delhi
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 ± 5°C
- Photoperiod (hrs dark / hrs light): 12 L:12 D cycles

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
The mode of administration of sodium arsenite was through drinking water.
Duration of treatment / exposure:
90 d
Doses / concentrationsopen allclose all
Dose / conc.:
0.2 mg/kg bw/day (nominal)
Remarks:
sodium arsenite
Dose / conc.:
2 mg/kg bw/day (nominal)
Remarks:
sodium arsenite

Examinations

Details of tissue and slide preparation:
MN test in femur bone marrow cells were carried according to the method of Schmid with minor modifications.

Results and discussion

Test results
Key result
Sex:
male/female
Genotoxicity:
positive
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Under the study conditions, both tested doses of sodium arsenite induced statistically significant micronucleated polychromatic erythrocytes as compared to the control group.

Executive summary:

A study was conducted to determine the genotoxicity of sodium arsenite by using the bone marrow micronucleus assay in Balb/c mice. The test substance was given to animals for a period of 90 days through drinking water at doses of 0.2 and 2 mg/kg bw/d. Genotoxicity was evaluated by studying the incidence of micronucleated polychromatic erythrocytes from bone marrow. Under the study conditions, both tested doses of sodium arsenite induced statistically significant micronucleated polychromatic erythrocytes as compared to the control group (Das, 2016).