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

Neurotoxicity

Administrative data

Endpoint:

neurotoxicity: oral

Remarks:

developmental

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:

Effects of prenatal aluminum treatment on development and behavior in the rat

Author:

Misawa, T. and Shigeta, S.

Year:

1993

Bibliographic source:

The Journal of Toxicological Sciences 18: 43-48

Materials and methods

Principles of method if other than guideline:

Developmental and behavioral effects of aluminum administration were studied in THA rats.

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, Wako Chemical Co., Japan
- Analytical purity: 98.0%

Test animals

Species:

rat

Strain:

other: THA

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

physiological saline

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

single dose

Frequency of treatment:

single treatment

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 900, 1800 mg/kg AlCl3
Basis:
nominal conc.

No. of animals per sex per dose:

3-4

Control animals:

yes, concurrent vehicle

Results and discussion

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

900 mg/kg bw/day (nominal)

Sex:

female

Remarks on result:

other: Generation: maternal (migrated information)

2

Dose descriptor:

LOAEL

Effect level:

900 mg/kg bw/day (nominal)

Sex:

male/female

Basis for effect level:

other: significant differences in body weight, timing of pinna detachment, eye opening, appearances of auditory startle, slower learning acquisition compared to controls

Remarks on result:

other: Generation: offspring (migrated information)

Any other information on results incl. tables

Dam data:

Two of three dams in the high dose group died immediately after administration. These dams were examined by autopsy without relevant findings. No significant difference in the body weight gain from the conception to parturition and other toxic signs by macroscopic examination were observed among the all survived groups. All survived dams delivered. No differences in the mean number of implantation sites, birth rate, mean litter size and maternal behaviors were observed among the three groups of rats.

Pup data:

Body weights of treatment rats were commonly lower than controls from birth to 28th day and significant differences were present between control and treatment groups.

Significant differences were observed between the aluminum treated offspring and controls in terms of body weight, timing of pinna detachment and eye opening, and appearnces of auditory startle. Slower learning acquisition was observed in 1800 mg/kg treated females.

These results suggest that single dose of aluminum chloride during prenatal period affects the development and behavior in rats.

Applicant's summary and conclusion

Conclusions:

Results from the present study indicated low avoidance rates during the initial stages of the test and apparent delay in learning acquisition among aluminum treated rats. This study was designed to clarify the developmental and behavioral effects of single dose of aluminum treatment during prenatalperiod in rats. The results suggest that the effects of single dose of 900 mg/kg and 1800 mg/kg aluminum administration on 15th day of gestation can induce long-term effects on the central nervous system.