Aluminium sulphate

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: I.p. administration is generally not recommended.

Data source

Reference

Reference Type:

publication

Title:

Assessment of genotoxicity of aluminium acetate in bone marrow, male germ cells and fetal liver cells of Swiss albino mice

Author:

D'Souza, Sr.P. et al.

Year:

2014

Bibliographic source:

Mutat Res Genet Toxicol Environ Mutagen 766:16 - 22

Materials and methods

Principles of method if other than guideline:

A sperm-abnormality assay was performed by treating male mice with a single dose and determining the frequency of abnormalities in sperm cells harvested 5 weeks later.

GLP compliance:

not specified

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Bis(acetato-O)hydroxyaluminium

EC Number:

205-518-2

EC Name:

Bis(acetato-O)hydroxyaluminium

Cas Number:

142-03-0

IUPAC Name:

aluminum hydroxide diacetate

Details on test material:

- Name of test material (as cited in study report): aluminium acetate, C₆H₉AlO₆
- Physical state: white, light hygroscopic powder
- Analytical purity: no data
- Lot/batch No.: 1049

Test animals

Species:

mouse

Strain:

Swiss

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: departmental animal house of the Department of Applied Zoology, Mangalore University, Mangalagangothri, India
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 25 ± 2 g
- Diet: commercial food pellets (Amrutha feeds, Bangaloer, India), ad libitum
- Water: unspecified source, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

water

Remarks:

double distilled

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

single treatment

Frequency of treatment:

single treatment

Duration of test:

5 weeks

Doses / concentrations

Remarks:

Doses / Concentrations:
50, 100 and 150 mg/kg bw
Basis:
nominal conc.

No. of animals per sex per dose:

5 males

Control animals:

yes, concurrent vehicle

Details on study design:

Eight-week-old virgin male mice were used. Post-treatment sampling was done after five weeks considering the duration required for spermatogenesis, and for sperm reaching the cauda epididymis. Sperm suspensions were made in phosphate-buffered saline (pH7.2) from both caudae and stained with 1% eosin-Y.

A total of 2000 sperm per animal were scored to determine the frequency of sperm abnormalities, which include hookless, amorphous, banana-shaped, folded, double-headed and double-tailed. The frequency of abnormal sperm was expressed as percentage, calculated with the formula: [number of abnormal sperm - total number of normal and abnormal sperm scored] × 100. In addition, testes weight and sperm count per epididymis were determined.

The positive control was 0.2 mL cyclophosphamide via intraperitoneal injection (50 mg/kg bw).

Statistics:

Statistical analysis of the data was performed by means of the paired t-test. A P-value < 0.05 was considered to correspond with statistical significance.

Results and discussion

Effect levels

Dose descriptor:

LOAEL

Effect level:

50 other: mg/kg bw

Based on:

test mat.

Sex:

male

Basis for effect level:

other: Increased percentage abnormal sperm

Observed effects

Aluminium acetate induced a dose-dependent and statistically significant increase in the frequency of abnormal sperm when compared with the control (see Table 1 under 'Any other information on results incl. tables'). There was a dose-dependent reduction in sperm count, which was significant in the 100 and 150 mg/kg bw groups. The body and testis weights were not significantly affected at any of the doses tested. The positive control cyclophosphamide induced a significant increase in sperm abnormalities and a significant reduction in sperm count (P < 0.001).

Any other information on results incl. tables

Table 1: Frequency of different types of abnormal sperm induced in Swiss albino mice after five weeks of treatment with aluminium acetate*

Dose (mg/kg bw)	A	B	H	F	DH	DT	Total abnormal	% abnormal sperm ± SEM
Control	33	8	31	26	2	7	107	1.07 ± 0.26
50 CP	182	43	149	100	12	25	511	5.11 ± 0.59c
50 Al	89	28	46	36	6	12	217	2.17 ± 0.31a
100 Al	115	62	48	57	5	25	312	3.12 ± 0.76b
150 Al	121	52	54	79	22	23	351	3.51 ± 0.81b

A, amorphous; B, banana shaped; H, hookless, F, folded; DH, double headed; DT, double tailed. (a)P < 0.05, (b)P < 0.01, (c)P < 0.001 (paired t-test). * 2000 sperm/animal. Al = aluminium acetate.