Aluminium trilactate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication which meets basic scientific principles; although pre-guideline study, equivalent to later adopted OECD guideline

Data source

Reference

Reference Type:

publication

Title:

Identification of Metal Allergens in the Local Lymph Node Assay

Author:

Basketter DA, et al.

Year:

1999

Bibliographic source:

American Journal of Contact Dermatitis, Vol 10, No 4 (December), 1999: pp 207-212

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

7784-13-6 (Aluminium chloride hexahydrate)

IUPAC Name:

7784-13-6 (Aluminium chloride hexahydrate)

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Aluminium chloride hexahydrate

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/Ca

Sex:

not specified

Details on test animals and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 to 12 weeks
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Study design: in vivo (LLNA)

Vehicle:

other: Petrolatum

Concentration:

5.0, 10.0, 25.0%

No. of animals per dose:

4

Details on study design:

Mice were treated with 25 µL of test material, or with an equal volume of the vehicle alone, on the dorsum of both ears. Treatment was performed once daily for 3 consecutive days. Five days after the initiation of exposure, all mice were injected by the tail vein with 250 µL of phosphate buffered saline (PBS) containing 20 µCi of tritiated thymidine. Mice were killed 5 hours later and the draining lymph nodes excised and pooled for each experimental group. A single-cell suspension of lymph node cells was prepared by mechanical disaggregation. The lymph node cell suspension was washed twice in an excess of PBS and then precipitated with 5% trichloroacetic acid (TCA) at 4°C for 18 h. Pellets were resuspended in TCA and the incorporation of tritiated thyrnidine measured by P-scintillation counting. A substance was regarded as a skin sensitiser if, at any test concentration, the proliferation in treated lymph nodes was threefold or greater than that in the concurrent vehicle treated controls.

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: 5.0%: 0.8 10.0%: 0.8 25.0%: 0.7

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: no data

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

Aluminium chloride hexahydrate is not sensitising in the LLNA.

Executive summary:

In a dermal sensitisation study equivalent to OECD guideline 429 with Aluminium chloride hexahydrate (99% a.i) in petrolatum, groups of 4 young adult CBA/Ca mice were tested using the LLNA method.

The test substance was applied in concentrations of 5.0, 10.0 and 25.0%. The resulting stimulating indices (SI) were 0.8, 0.8 and 0.7, respectively.  

In this study, Aluminium chloride hexahydrate is not a dermal sensitiser.