Aluminium sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: 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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

10124-27-3

Cas Number:

10124-27-3

IUPAC Name:

10124-27-3

Constituent 2

Reference substance name:

aluminium chloride hexahydrate

EC Number:

917-806-1

IUPAC Name:

aluminium chloride hexahydrate

Details on test material:

- Name of test material :other- 20% aluminium chloride hexahydrate in ethanol
Name of test material: aluminium chloride hexahydrate
- CAS Number: :10124-27-3
- Molecular formula (if other than submission substance): AlCl3•6H2O
- Molecular weight (if other than submission substance): 241.43 g/mol
- Smiles notation (if other than submission substance): [Al](Cl)(Cl)Cl
- Substance type:inorganic
- Physical state:solid
- Appearance: white or pale yellow solid, hygroscopic
- Density – 1.3 g/cm3
- Melting point- 0 °C
- Solubility in water - 43.9 g/100 ml (0 °C), 44.9 g/100 ml (10 °C), 45.8 g/100 ml (20 °C),46.6 g/100 ml
(30 °C), 47.3 g/100 ml (40 °C), 48.1 g/100 ml (60 °C), 48.6 g/100 ml (80 °C), 49 g/100 ml (100 °C
- Solubility: soluble in hydrogen chloride, ethanol, chloroform, carbon tetrachloride slightly soluble in benzene

Test animals

Species:

other: humans

Test system

Type of coverage:

open

Preparation of test site:

shaved

Vehicle:

other:

Controls:

not required

Amount / concentration applied:

aluminium chloride hexahydrate 20% W/W ethanol

Duration of treatment / exposure:

4 weeks.

Observation period:

4 weeks.

Number of animals:

12 patients.

Details on study design:

The efficacy of topical aluminium chloride hexahydrate 20% W/W ethanol (ACH) in the treatment symptomatic palmar hyperhidrosis was studied in 12 patients. A half-sided control single blind (assessor blind) study was done. Patients applied ACH on one palm daily for 4 weeks. The response to treatment was measured objectively with an evaporimeter. There was significant fall of skin water vapor loss (SVL) on treated palms compared with untreated palms.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

4 patients developed skin irritation from aluminium chloride hexahydrate (ACH)

Time point:

other: 1, 2, 3, and 4 week

Score:

0 - 1

Max. score:

1

Reversibility:

fully reversible within: 1 week

Remarks on result:

other: daily application of 20% aluminium chloride hexahydrate in ethanol to the palm produced skin irritation in 4 of 12 patients, which disappeared in 3 of these patients after 1 week

Irritant / corrosive response data:

daily application of 20% aluminium chloride hexahydrate in ethanol to the palm produced skin irritation in 4 of 12 patients, which disappeared in 3 of these patients after 1 week

Other effects:

There was significant fall of skin water vapor loss (SVL) on treated palms compared with untreated palms.
The basal mean SVL of treated palms and untreated palms were 79.9 and 77.9 g water/m2/h, respectively (n.s.).
The mean SVLs of treated vs. untreated palms at week 1, 2, 3, and 4 were 66.4 vs. 79.7 (p less than 0.05), 56.6 vs. 72.2 (p less than 0.001), 58.2 vs. 72.5 (p = 0.1), and 51.4 vs. 72.7 (p less than 0.001) g water/m2/h, respectively.

Any other information on results incl. tables

The efficacy of topical aluminium chloride hexahydrate 20% W/W ethanol (ACH) in the treatment symptomatic palmar hyperhidrosis was studied in 12 patients. A half-sided control single blind (assessor blind) study was done. Patients applied ACH on one palm daily for 4 weeks. The response to treatment was measured objectively with an evaporimeter. There was significant fall of skin water vapor loss (SVL) on treated palms compared with untreated palms. The basal mean SVL of treated palms and untreated palms were 79.9 and 77.9 g water/m2/h, respectively (n.s.). The mean SVLs of treated vs. untreated palms at week 1, 2, 3, and 4 were 66.4 vs. 79.7 (p less than 0.05), 56.6 vs. 72.2 (p less than 0.001), 58.2 vs. 72.5 (p = 0.1), and 51.4 vs. 72.7 (p less than 0.001) g water/m2/h, respectively. The mean SVL of treated palms returned near basal rate within 1 week of stopping treatment. Four patients developed skin irritation from ACH; in three this disappeared after 1 week and they were able to continue with treatment; one withdrew from the study because of the severe irritation. All patients reported that the ACH reduced palmar sweating within 48 hours of application; its effect disappeared within 48 hours after stopping treatment. ACH appeared to be useful in rapid control of palmar hyperhydrosis

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

daily application of 20% aluminium chloride hexahydrate in ethanol to the palm produced skin irritation in 4 of 12 patients, which disappeared in 3 of these patients after 1 week

Executive summary:

The efficacy of topical aluminium chloride hexahydrate 20% W/W ethanol (ACH) in the treatment symptomatic palmar hyperhidrosis was studied in 12 patients. A half-sided control single blind (assessor blind) study was done. Patients applied ACH on one palm daily for 4 weeks. The response to treatment was measured objectively with an evaporimeter. There was significant fall of skin water vapor loss (SVL) on treated palms compared with untreated palms. The basal mean SVL of treated palms and untreated palms were 79.9 and 77.9 g water/m2/h, respectively (n.s.). The mean SVLs of treated vs. untreated palms at week 1, 2, 3, and 4 were 66.4 vs. 79.7 (p less than 0.05), 56.6 vs. 72.2 (p less than 0.001), 58.2 vs. 72.5 (p = 0.1), and 51.4 vs. 72.7 (p less than 0.001) g water/m2/h, respectively. The mean SVL of treated palms returned near basal rate within 1 week of stopping treatment. Four patients developed skin irritation from ACH; in three this disappeared after 1 week and they were able to continue with treatment; one withdrew from the study because of the severe irritation. All patients reported that the ACH reduced palmar sweating within 48 hours of application; its effect disappeared within 48 hours after stopping treatment. ACH appeared to be useful in rapid control of palmar hyperhydrosis.