Aluminum sodium oxide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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:

Development and Validation of an Alternative Dermal Sensitization Test: The Mouse Ear Swelling Test (MEST)

Author:

Gad, S.C. et al.

Year:

1986

Bibliographic source:

Toxicol Appl Pharmacol. 84(1):93-114

Materials and methods

Principles of method if other than guideline:

Mouse Ear Swelling Test (MEST)

GLP compliance:

not specified

Type of study:

mouse ear swelling test

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

Molecular formula:

AlCl3

IUPAC Name:

aluminum trichloride

Details on test material:

- Name of test material (as cited in study report): Aluminum chloride
- Analytical purity: at least 98%

In vivo test system

Test animals

Species:

mouse

Strain:

CF-1

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, open

Vehicle:

other: 70% ethanol

Concentration / amount:

10%

Day(s)/duration:

Day 0-3

Challenge

No.:

#1

Route:

epicutaneous, open

Vehicle:

other: 70% ethanol

Concentration / amount:

10%

Day(s)/duration:

Day 10

No. of animals per dose:

Control group: at least 5
Test group: at least 10

Details on study design:

RANGE FINDING TESTS: concentration was reported to have been selected on the basis of irritation.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Exposure period: -
- Test groups: test substance in vehicle
- Control group: vehicle
- Site: clipped abdomen (after intradermal injection of Freund's Complete Adjuvant and tape-stripping)
- Frequency of applications: once per day
- Duration: days 0-3
- Concentrations: 10%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 10
- Exposure period: -
- Test groups: test substance in vehicle on the left ear; vehicle on the right ear
- Control group: test substance in vehicle on the left ear; vehicle on the right ear
- Site: ears
- Concentrations: 10%
- Evaluation (hr after challenge): 24 and 48 h

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Group:

test chemical

Dose level:

10%

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

Table 1. Results from the topical study

 

	MEST results		GPMT results	Closed patch results	Human results
	% sensitised	% swelling
Aluminum chloride	0	103	0 (1, 2)	0 (1, 2)	0 (1, 2)

 

(1) Results are percentage sensitised

(2) Reported as literature value cited from Magnusson, B. and Kligman, A.M. (1969) J Invest Dermatol 52:268-276.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Conclusions:

This publication describes the development and validation of the Mouse Ear Swelling Test for a number of known sensitisers and non-sensitisers and compares the results with available data from other testing systems (GPMT, Closed Patch Test, Human data). Under the conditions described in this study, aluminium chloride at 10% in 70% ethanol was not sensitising in the Mouse Ear Swelling Test, corroborating negative results previously published by Magnusson and Kligman (1969).