Aluminium sulphate

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

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

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.7600 (Dermal Penetration)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Dialuminium chloride pentahydroxide

EC Number:

234-933-1

EC Name:

Dialuminium chloride pentahydroxide

Cas Number:

12042-91-0

IUPAC Name:

dialuminium chloride pentahydroxide

Constituent 2

Reference substance name:

Aluminium chlorohydrate

IUPAC Name:

Aluminium chlorohydrate

Test material form:

solid: compact

Details on test material:

- Name of test material-other-Aluminium chlorohydrate (ACH)

-Name of test material : Aluminium chlorohydrate
-EC name: dialuminium chloride pentahydroxide
- CAS mumber: 12042-91-0
- EC number: 234-933-1
- Molecular formula : Al2Cl(OH)5
- Molecular weight : 174.452776 g/mol
- Smiles notation – Al]([Al](O)(O)Cl)(O)(O)O
- InChI notation- 1/2Al.ClH.5H2O/h;;1H;5*1H2/q2*+3;;;;;;/p-6/rAl2ClH5O5/c3-1(4,5)2(6,7)8/h4-8H
- Structural formula attached as image file : see Fig.1
- Substance type:inorganic
- Physical state: solid
- Density: 1,35g/cm3
- Melting point: >100 °C
- Boiling point: 110-115 °C
- Solubility in water: 500 g/l at 20 o C

Radiolabelling:

yes

Remarks:

radioisotope 26Al.

Test animals

Species:

other: human

Strain:

other: one man and one woman

Sex:

male/female

Administration / exposure

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Duration of exposure:

43 days

Doses:

84 mg

Control animals:

yes

Details on study design:

Aluminium chlorohydrate (ACH), the active ingredient in many antiperspirants, was labeled with the radioisotope 26Al. The labeled ACH was then fractionated into about 100 samples using gel filtration chromatography. Each fraction was analyzed for 26Al and total aluminium content. Aluminium-26 was only detected in the fractions that also contained aluminium, which verified that the ACH was uniformly labeled. 84 mg of the labeled ACH was then applied to a single underarm of two adult subjects with blood and urine samples being collected over 7 weeks. Tape-stripping and mild washings of the skin were also collected for the first 6 days.
Results indicate that only 0.012% of the applied aluminium was absorbed through the skin.

Results and discussion

Signs and symptoms of toxicity:

no effects

Dermal irritation:

no effects

Absorption in different matrices:

26Al-chlorohydrate (aluminum complex in antiperspirant) was applied to a single underarm of one man and one woman. The cumulative urinary excretion after 43 days following the application accounted for 0.0082% (male) and for 0.016% (female) of the applied dose.
After correcting this fraction for the aluminum not excreted in urine (15% of the absorbed dose), this application was estimated to result in a dermal bioavailability of about 0.012%.

Total recovery:

Guillard et al. (2004) reported on one clinical case in which a woman who used an antiperspirant cream with aluminum chlorohydrate over four years showed elevated levels of aluminum in plasma and urine (10.47 μg/dL in plasma12).
When the woman discontinued use, concentrations in her urine and plasma dropped to reported normal values after the third and eighth months, respectively.
References: Olivier Guillard PhD, Bernard Fauconneau PhD, Didier Olichon PhD, Geneviève Dedieu and Roger Deloncle PhD,
Hyperaluminemia in a woman using an aluminum-containing antiperspirant for 4 years ,The American Journal of Medicine,Volume 117, Issue 12, 15 December 2004, Pages 956-959 ,

Percutaneous absorption

Percutaneous absorption 1

Dose:

84 mg

Parameter:

percentage

Absorption:

0 %

Remarks on result:

other: 43 days

Remarks:

0.0082% (male)

Percutaneous absorption 2

Dose:

84 mg

Parameter:

percentage

Absorption:

0 %

Remarks on result:

other: 43 days

Remarks:

0.016% (female)

Applicant's summary and conclusion

Conclusions:

One-time use of Aluminium chlorohydrate (ACH) applied to the skin is not a significant contribution to the body burden of aluminium.
Results indicate that only 0.012% of the applied aluminium was absorbed through the skin. At this rate, about 4 microg of aluminium is absorbed from a single use of ACH on both underarms. This is about 2.5% of the aluminium typically absorbed by the gut from food over the same time period.

Executive summary:

Aluminium chlorohydrate (ACH), the active ingredient in many antiperspirants, was labeled with the radioisotope 26Al. The labeled ACH was then fractionated into about 100 samples using gel filtration chromatography. Each fraction was analyzed for 26Al and total aluminium content.

Aluminium-26 was only detected in the fractions that also contained aluminium, which verified that the ACH was uniformly labeled. 84 mg of the labeled ACH was then applied to a single underarm of two adult subjects with blood and urine samples being collected over 7 weeks. Tape-stripping and mild washings of the skin were also collected for the first 6 days.

Results indicate that only 0.012% of the applied aluminium was absorbed through the skin. At this rate, about 4 microg of aluminium is absorbed from a single use of ACH on both underarms. This is about 2.5% of the aluminium typically absorbed by the gut from food over the same time period. Therefore, a one-time use of ACH applied to the skin is not a significant contribution to the body burden of aluminium.