Arsenic

Genetic toxicity: in vivo

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

Test material information

Constituent 1

Reference substance name:

Sodium dioxoarsenate

EC Number:

232-070-5

EC Name:

Sodium dioxoarsenate

Cas Number:

7784-46-5

IUPAC Name:

sodium dioxoarsenate(1-)

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 / concentrations

Doses / concentrations 1

Dose / conc.:

0.2 mg/kg bw/day (nominal)

Remarks:

sodium arsenite

Doses / concentrations 2

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).