Aluminum chloride, basic

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

No data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Study was not conducted according to a guideline or under GLP conditions. Detailed methods and results not reported.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1959

Materials and methods

Test guideline

Qualifier:

no guideline followed

GLP compliance:

no

Remarks:

pre-GLP

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Aluminum chlorohydroxide complex, 22 %

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 4 months
- Weight at study initiation: 1500-2500 g

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

No data

Frequency of treatment:

No data

Doses / concentrations

Remarks:

Doses / Concentrations:
Subcutaneous: 110 mg; intracutaneous: 22 mg of Aluminum chlorohydroxide complex, 22 %
Basis:
nominal per unit area

No. of animals per sex per dose:

No data

Control animals:

no

Positive control:

None

Examinations

Observations and examinations performed and frequency:

- Reactions from the injections were measured after 24 and 48 h, 1, 2, 3 and 4 weeks. The diameter of the inflammatory infiltrate was determined and used as an index of the severity of the reaction.
- Biopsy specimens were taken at intervals to correlate the gross and microscopic findings.

Other examinations:

None

Statistics:

None

Results and discussion

Results of examinations

Clinical signs:

not examined

Dermal irritation:

effects observed, treatment-related

Mortality:

not examined

Body weight and weight changes:

not examined

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

not examined

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

Acute inflammatory reactions with tissue necrosis and ulceration were noted in association with the subcutaneous and intracutaneous injection of the aluminum compounds. There was a more marked reaction at the injection sites in areas that had been previously injured. Repeated injections, either subcutaneously or intracutaneously, resulted in the same type of cutaneous ulcers, but these were not felt to be more severe than those following the original injections. Granulomas were seen only after the subcutaneous injection of aluminum chlorohydroxide complex. All lesions went on to normal, although delayed, healing. The percutaneous application of these chemical compounds failed to produce any significant lesions.
- See the attached document for detailed results.

Effect levels

Dose descriptor:

NOAEL

Remarks on result:

not determinable

Remarks:

no NOAEL identified

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

See the attached document for tables of results

Applicant's summary and conclusion

Conclusions:

Acute inflammatory reactions with tissue necrosis and ulceration were noted in association with the subcutaneous and intracutaneous injection of the aluminum compounds. There was a more marked reaction at the injection sites in areas that had been previously injured. Repeated injections, either subcutaneously or intracutaneously, resulted in the same type of cutaneous ulcers, but these were not felt to be more severe than those following the original injections. Granulomas were seen only after the subcutaneous injection of aluminum chlorohydroxide complex. All lesions went on to normal, although delayed, healing. The percutaneous application of these chemical compounds failed to produce any significant lesions.

Executive summary:

Study was conducted to determine the tissue reactions to subcutaneous and intracutaneous injections and to percutaneous application of a variety of aluminum salts. Aluminum salts were administered as follows:

Subcutaneous (0.5 mL), using the skin of the rabbit's back; intracutaneous (0.1 mL), using the skin on the inner aspect of the rabbit's ear; percutaneous using cotton pads saturated with test solution and held to the skin of the rabbit’s ear by Scotch tape. The three basic routes of administration were modified further by being applied to intact undamaged skin, damaged skin and finally by repeated applications.

Aluminum chlorohydroxide complex, 22 %: Subcutaneous - 110 mg; intracutaneous - 22 mg

Aluminum sulfate, 17 %: Subcutaneous - 85 mg; intracutaneous - 17 mg

 

Acute inflammatory reactions with tissue necrosis and ulceration were noted in association with the subcutaneous and intracutaneous injection of the aluminum compounds. There was a more marked reaction at the injection sites in areas that had been previously injured. Repeated injections, either subcutaneously or intracutaneously, resulted in the same type of cutaneous ulcers, but these were not felt to be more severe than those following the original injections. Granulomas were seen only after the subcutaneous injection of aluminum chlorohydroxide complex. All lesions went on to normal, although delayed, healing. The percutaneous application of these chemical compounds failed to produce any significant lesions.