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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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Administrative data

in vivo mammalian germ cell study: cytogenicity / chromosome aberration
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
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication which meets basic scientific principles

Data source

Reference Type:
Effects of aluminium salts on bone marrow chromosomes in rats in vivo
Roy, AK et al.
Bibliographic source:
Cytobios 66: 105-111

Materials and methods

Test guideline
no guideline followed
Principles of method if other than guideline:
Aluminium sulphate was orally administered to rats daily for 7, 14 or 21 days. Bone marrow chromosomes were analysed for aberrations.
GLP compliance:
Type of assay:
chromosome aberration assay

Test material

Constituent 1
Reference substance name:
7784-31-8 (Aluminium sulphate)
7784-31-8 (Aluminium sulphate)
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Aluminium sulphate Al2(SO4)3 x 18H2O
- Analytical purity: no data

Test animals

not specified

Administration / exposure

Route of administration:
oral: unspecified
- Vehicle(s)/solvent(s) used: deionised water
Duration of treatment / exposure:
7, 14 or 21 d
Frequency of treatment:
once daily
Post exposure period:
24 h
Doses / concentrationsopen allclose all
Doses / Concentrations:
0, 212, 265, 353, 530, 1060, 2120 mg Al2(SO4)3x18H2O/kg bw/d
nominal conc.
Doses / Concentrations:
0, 17, 22, 28, 43, 85, 172 mg Al/kg bw/d
nominal conc.
No. of animals per sex per dose:
5 for each time point
Control animals:
yes, concurrent vehicle
Positive control(s):


Tissues and cell types examined:
bone marrow chromosomes
Details of tissue and slide preparation:
Colchicine (0.04%) was injected intraperitoneally, 90 min before sacrifice.
From each animal, 2000 cells were scored for the mitotic index and 60 well scattered metaphase plates for chromosomal aberration, making a total of 10000 cells and 300 metaphases per set, respectively. For the calculation of breaks/cell, chromatid breaks were taken as a single break, dicentrics and translocations as two breaks. Gaps, polyploid and pulverised cells were recorded separately and not included in the calculation of breaks per cell.
The data were analysed statistically by comparing each group with controls by Student´s t-test and further using the Cochran-Armitage trend test (dose response).

Results and discussion

Test results
Vehicle controls validity:
Negative controls validity:
not applicable
Positive controls validity:
not applicable

Applicant's summary and conclusion

Interpretation of results (migrated information): positive
Oral administration of Aluminium sulphate to rats for 7, 14 or 21 d induced a dose dependent inhibition of dividing bone marrow cells and an increase in chromosomal aberrations. The effect was not influenced by the duration of exposure.
Executive summary:

In a rat bone marrow micronucleus assay, 5 male rats/dose were treated orally with Aluminium sulphate ( Al2(SO4)3 x 18H2O) at doses of

0, 212, 265, 353, 530, 1060, 2120 mg Al2(SO4)3x18H2O/kg bw/d, corresponding to 0, 17, 22, 28, 43, 85, 172 mg Al/kg bw/d

daily for 7, 14 or 21 days.  Bone marrow cells were harvested at 24 h post-treatment.  The vehicle was deionised water.

In the bone marrow cells, the mitotic index decreased in direct proportion to the dose used. The decrease was highly pronounced in animals treted with the two higher doses.

The frequency of abnormal cells increased with dose and duration of exposure to Aluminium sulphate. During all three sampling times the trend test p value was found to be highly significant. A duration dependent effect was not found with the lowest (7 mg Al/kg bw/d) dose. Most aberrations were chromatid breaks. Translocations were recorded in higher doses.


There was a significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after any treatment time.