Registration Dossier

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Modification of metal-induced micronuclei formation in mouse bone marrow erythrocytes by Phyllanthus fruit extract and ascorbic acid
Author:
Roy, A. K. et al.
Year:
1992
Bibliographic source:
Toxicology Letters 62: 9-17

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Animals were treated with aluminium sulphate and the frequency of micronucleated cells were determined.
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
7784-31-8
Cas Number:
7784-31-8
IUPAC Name:
7784-31-8
Details on test material:
- Name of test material (as cited in study report): aluminium sulphate Al2(SO4)3x18H2O from Sarabhai M. Chemicals, India
- Analytical purity: no data

Test animals

Species:
mouse
Strain:
Swiss
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: laboratory bred
- Age at study initiation: 6 weeks
- Diet: commercial pellet, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 50± 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: physiol. saline
Duration of treatment / exposure:
two single treatments
Frequency of treatment:
daily, every 24 h
Post exposure period:
24 and 48 h
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 250, 500 mg Al2(SO4)3x18H2O/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
12
Control animals:
yes, concurrent vehicle
Positive control(s):
mitomycin C
- Route of administration: intraperitoneal injection
- Doses / concentrations: 1.5 mg/kg bw

Examinations

Tissues and cell types examined:
Tissue: bone marrow
Celly type: bone marrow cells
Details of tissue and slide preparation:
METHOD OF ANALYSIS:
One thousand polychromatic erythrocytes (PCEs) were scored per animal for determining the frequency of micronucleated cells. In each optic field, a total of 1000 normochromatic erythrocytes (NCEs) were also counted in order to calculate the ratio of NCEs to PCEs to evaluate cytotoxic effects, if any.
Statistics:
Analysis was carried out following the two-way ANOVA test (with replication) and Duncan´s multiple range test to compare the significance of difference, if any, amongst the different experimental sets.

Results and discussion

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

Any other information on results incl. tables

The frequency of micronucleated cells increased with increasing doses of aluminium sulphate. The increase was significant (p < 0.05) only with the higher concentration (500 mg/kg bw) of the test chemical.

Table 1. Effect of intraperitoneally administered aluminium sulfate on the frequency of PCEs in bone marrow of cells of mice

 

Treatment group

Dose

[mg/kg]

Harvest time

[h]

Mean frequency of PCE with MN

 

NCE/PCE ratio

Vehicle control

0

24

0.23±0.06

0.98±0.02

 

0

48

0.17±0.06

1.01±0.02

Test substance

250

24

0.50±0.11

1.01±0.01

 

250

48

0.43±0.16

1.01±0.01

Test substance

500

24

1.23±0.10

1.01±0.02

 

500

48

1.13±0.16

1.01±0.01

Positive control (Mitomycin)

1.5

24

2.30±0.18

1.04±0.02

 

1.5

48

2.27±0.16

1.05±0.02

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): positive