Reaction mass of aluminium hydroxide and aluminium nitrate and aluminium sulphate

Genetic toxicity: in vivo

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

Test material information

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