Aluminium sulphate

Health surveillance data

Administrative data

Endpoint:

health surveillance data

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliable with restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Materials and methods

Study type:

human medical data

Endpoint addressed:

genetic toxicity

toxicity to reproduction / fertility

developmental toxicity / teratogenicity

neurotoxicity

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The mother had taken an average of 75 Maalox® tablets (containing 200 mg of aluminium hydroxide per tablet) each day during the pregnancy. These results suggested that the high levels of aluminium intake by the mother, during critical periods of the foetus’ brain development, resulted in neurological damage to the infant.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium hydroxide

EC Number:

244-492-7

EC Name:

Aluminium hydroxide

Cas Number:

21645-51-2

IUPAC Name:

aluminum trihydroxide

Test material form:

solid: compact

Details on test material:

- Name of test material :aluminium hydroxide
- Molecular formula :Al(OH)3,
- Molecular weight :78.00 g/mol
- Smiles notation :[Al+3].[OH-].[OH-].[OH-]
- InChl :1/Al.3H2O/h;3*1H2/q+3;;;/p-3
- Structural formula attached as image file : see Fig.1
- Substance type: inorganic
- Physical state: White amorphous powder
- Density :2.42 g/cm³, solid
- Melting point: 300 °C, 573 K, 572 °F
- Solubility in water: 0.0001 g/100 mL (20 °C)
-Solubility: soluble in acids, alkalis, HCl, H2SO4
-Acidity (pKa) >7
-Flash point: Non-flammable

Method

Type of population:

other:

Ethical approval:

not applicable

Details on study design:

The mother had taken an average of 75 Maalox® tablets (containing 200 mg of aluminium hydroxide per tablet) each day during the pregnancy. These results suggested that the high levels of aluminium intake by the mother, during critical periods of the foetus’ brain development, resulted in neurological damage to the infant.

Results and discussion

Results:

The case of a 9-year-old female who was found not to be progressing developmentally at the age of 2 months. At the age of 4 months the child was diagnosed with a neurodegenerative disorder with severe mental retardation. Congenital metabolic disorders were considered as a manifestation; however, all enzyme levels related to these disorders were within the normal range. The infant had a high Apgar score at birth and there was no recorded neonatal distress. The patient’s condition progressively worsened, resulting in death at the age of 9 years. Autopsy revealed CNS cortical atrophy, small basal ganglia, and hypomyelination of the spinal cord, cerebral cortex, subcortex and cerebellar white matter. Following autopsy it was discovered that the mother had taken an average of 75 Maalox® tablets (containing 200 mg of aluminium hydroxide per tablet) each day during the pregnancy. These results suggested that the high levels of aluminium intake by the mother, during critical periods of the foetus’ brain development, resulted in neurological damage to the infant.

Applicant's summary and conclusion

Conclusions:

These results suggested that the high levels of aluminium intake by the mother, during critical periods of the foetus’ brain development, resulted in neurological damage to the infant. It should also be considered that concurrent ingestion of aluminium-containing antacids with acid-containing foodstuffs can results in enhanced GI absorption of aluminium

Executive summary:

Gilbert-Barness et al. (1998) reported the case of a 9-year-old female who was found not to be progressing developmentally at the age of 2 months. At the age of 4 months the child was diagnosed with a neurodegenerative disorder with severe mental retardation. Congenital metabolic disorders were considered as a manifestation; however, all enzyme levels related to these disorders were within the normal range. The infant had a high Apgar score at birth and there was no recorded neonatal distress. The patient’s condition progressively worsened, resulting in death at the age of 9 years. Autopsy revealed CNS cortical atrophy, small basal ganglia, and hypomyelination of the spinal cord, cerebral cortex, subcortex and cerebellar white matter. Following autopsy it was discovered that the mother had taken an average of 75 Maalox® tablets (containing 200 mg of aluminium hydroxide per tablet) each day during the pregnancy. These results suggested that the high levels of aluminium intake by the mother, during critical periods of the foetus’ brain development, resulted in neurological damage to the infant. It should also be considered that concurrent ingestion of aluminium-containing antacids with acid-containing foodstuffs can results in enhanced GI absorption of aluminium . Pregnant women may be more likely to consume these types of foods (e.g. orange juice, yogurt), further adding to the concern of aluminium-containing antacid use during pregnancy.