Reaction mass of aluminium and magnesium oxide and spinel (Mg(AlO2)2)

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

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

Adequacy of study:

supporting study

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:

Experimental Studies on the Effects of Aluminum on Pregnancy and Fetal Development

Author:

Benett, R. W. et al.

Year:

1975

Bibliographic source:

Anat. Anz. 138: 365-378

Materials and methods

Principles of method if other than guideline:

The present report describes experimental studies carried out in the rat in order to determine the effects of aluminum on pregnancy and fetal development.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium chloride

EC Number:

231-208-1

EC Name:

Aluminium chloride

Cas Number:

7446-70-0

IUPAC Name:

aluminum trichloride

Details on test material:

- Name of test material (as cited in study report): Aluminum chloride
- Analytical purity: no data

Test animals

Species:

rat

Strain:

other: Holtzman

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

water

Analytical verification of doses or concentrations:

not specified

Details on mating procedure:

Female albino rats of the Holtzman strain were caged overnight with fertile males of the same strain, using one male for three females. At 10 a.m. the following morning, mating was determined by the presence of spermatozoa in the vaginal smears, and this was considered to be first day of pregnancy.

Duration of treatment / exposure:

acute treatment: 1 single day
chronic treatment: 5 days (GD 9-13 or GD 14-18)

Frequency of treatment:

acute: single treatment
chronic: once daily

Duration of test:

~20 days

No. of animals per sex per dose:

5-10

Control animals:

yes, concurrent vehicle

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

1

Dose descriptor:

LOAEL

Effect level:

15.2 mg/kg bw/day (nominal)

Basis for effect level:

other: maternal toxicity

2

Dose descriptor:

LOAEL

Effect level:

15.2 mg/kg bw/day (nominal)

Basis for effect level:

other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:yes

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Any other information on results incl. tables

Acute treatment:

Maternal weight gain was not different from control. Mean weights of fetuses were not significantly different from those of the controls. The number of dead fetuses was low and not significantly different from the controls. The incidence of resorption was not significantly increased. Fetuses showed no apparent abnormalities.

Chronic treatment:

A high incidence of maternal death followed treatment with high dose-levels of the substance. Maternal weight gain during the entire gestational period was less in treated animals, compared to controls. In many cases, maternal liver was severely damaged as a result of the treatment. The offspring of mothers treated with aluminum chloride showed significant growth retardation as well as skeletal defects. In addition the incidence of fetal deaths and resorption was significantly increased.