Aluminium nitrate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

Not relevant

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Limited experimental data are presented in this published study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Effects of aluminium salts on bone marrow chromosomes in rats in vivo

Author:

Roy AK, Talukder G & Sharma A

Year:

1991

Bibliographic source:

Cytobios. 66 (1991) 105-111

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The effects of Aluminium sulphate (Aluminium Sulphate 18 H20) was tested on bone marrow chromosomes in rats in vivo at six dose levels: 2.120, 1.060, 530, 353, 265, and 212 mg/kg/bw. For each concentration, fifteen animals were used and five animals were sacrificed at the end of each week. 3 sampling times occurred at 7, 14 and 21 days. Bone marrow chromosomes were prepared by the standard protocol. From each animal, 2,000 cells were scored for the mitotic index and 60 well scattered metaphase plates for chromosomal aberration, making a total of 10,000 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.

GLP compliance:

not specified

Type of assay:

chromosome aberration assay

Test material

Test material information

Constituent 1

Reference substance name:

aluminium sulphate 18 H2O

IUPAC Name:

aluminium sulphate 18 H2O

Test material form:

not specified

Details on test material:

No information available

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No information

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

No information

Details on exposure:

The effects of Aluminium sulphate (Aluminium Sulphate 18 H20) was tested on bone marrow chromosomes in rats in vivo dosed orally at six dose levels: 2.120, 1.060, 530, 353, 265, and 212 mg/kg/bw. For each concentration, fifteen animals were used and five animals were sacrificed at the end of each week. 3 sampling times occurred at 7, 14 and 21 days.

Duration of treatment / exposure:

Five animals were sacrificed at the end of each week. 3 sampling times occurred at 7, 14 and 21 days.

Frequency of treatment:

daily

Post exposure period:

five animals were sacrificed at the end of each week. 3 sampling times occurred at 7, 14 and 21 days.

Doses / concentrations

Remarks:

Doses / Concentrations:
2.120, 1.060, 530, 353, 265, and 212 mg/kg/bw.
Basis:

No. of animals per sex per dose:

15 per group

Control animals:

not specified

Positive control(s):

No data

Examinations

Tissues and cell types examined:

For each concentration, fifteen animals were used and five animals were sacrificed at the end of each week. 3 sampling times occurred at 7, 14 and 21 days. Bone marrow chromosomes were prepared by the standard protocol. From each animal, 2,000 cells were scored for the mitotic index and 60 well scattered metaphase plates for chromosomal aberration, making a total of 10,000 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.

Details of tissue and slide preparation:

For each concentration, fifteen animals were used and five animals were sacrificed at the end of each week. 3 sampling times occurred at 7, 14 and 21 days. Bone marrow chromosomes were prepared by the standard protocol. From each animal, 2,000 cells were scored for the mitotic index and 60 well scattered metaphase plates for chromosomal aberration, making a total of 10,000 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.

Evaluation criteria:

No information given in publication

Statistics:

No data

Results and discussion

Test results

Sex:

not specified

Genotoxicity:

positive

Toxicity:

not specified

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

Oral administration of Aluminium sulphate to rats for prolonged periods induced dose dependent inhibition of dividing cells and an increase in chromosomal aberrations. The effect was not influenced by the duration of exposure

Any other information on results incl. tables

Bone marrow chromosomes were prepared by the standard protocol. From each animal, 2,000 cells were scored for the mitotic index and 60 well scattered metaphase plates for chromosomal aberration, making a total of 10,000 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.

Oral administration of Aluminium sulphate to rats for prolonged periods induced dose dependent inhibition of dividing cells and an increase in chromosomal aberrations. The effect was not influenced by the duration of exposure.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): ambiguous
Oral administration of Aluminium sulphate to rats for prolonged periods induced dose dependent inhibition of dividing cells and an increase in chromosomal aberrations. The effect was not influenced by the duration of exposure.

Executive summary:

The effects of Aluminium sulphate (Aluminium Sulphate 18 H20) was tested on bone marrow chromosomes in rats in vivo at six dose levels: 2.120, 1.060, 530, 353, 265, and 212 mg/kg/bw. For each concentration, fifteen animals were used and five animals were sacrificed at the end of each week. 3 sampling times occurred at 7, 14 and 21 days. Bone marrow chromosomes were prepared by the standard protocol. From each animal, 2,000 cells were scored for the mitotic index and 60 well scattered metaphase plates for chromosomal aberration, making a total of 10,000 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.

Oral administration of Aluminium sulphate to rats for prolonged periods induced dose dependent inhibition of dividing cells and an increase in chromosomal aberrations. The effect was not influenced by the duration of exposure.