Aluminium trilactate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-07-02 to 2012-07-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Version / remarks:

24 August 2009

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

adopted 22 July 2010

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium trilactate

EC Number:

242-670-9

EC Name:

Aluminium trilactate

Cas Number:

18917-91-4

Molecular formula:

C9H15AlO9

IUPAC Name:

Aluminium trilactate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Aluminiumtrilactat

Test animals

Species:

other: not applicable, in vitro test

Strain:

other: not applicable, in vitro test

Details on test animals or test system and environmental conditions:

TEST SYSTEM
EPISKIN Small ModelTM (EPISKIN-SM, 0.38 cm², Batch no.: 12-EKIN-028), SkinEthic Laboratories, Lyon, France

On the day of receipt the tissues were transferred to 12-well plates and preincubated with prewarmed Maintenance Medium for 24 hours at 37°C.

All incubations, with the exception of the test substance incubation of 15 minutes at room temperature, were carried out in a controlled environment, in which optimal conditions were a humid atmosphere of 80 - 100% (actual range 83 - 98%), containing 5.0 ± 0.5% CO2 in air in the dark at 37.0 ± 1.0°C (actual range 36.3 - 37.7°C). Temperature and humidity were continuously monitored throughout the experiment. The CO2 percentage was monitored once on each working day.

Test system

Type of coverage:

open

Preparation of test site:

other: not applicable, in vitro test

Vehicle:

unchanged (no vehicle)

Remarks:

moistened with water

Controls:

other: not applicable, in vitro test

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10.2 to 12.1 mg, moistened with 5 µL water

Duration of treatment / exposure:

15 min

Observation period:

44 h

Number of animals:

not applicable, in vitro test

Details on study design:

negative control: 25 μL PBS
positive control: 25 μL 5% SDS in PBS
3 replicates of test substance, negative and positive control

After the exposure period of 15 minutes at room temperature, the tissues were washed with phosphate buffered saline to remove residual test substance. After rinsing the cell culture inserts were each dried carefully and moved to a new well on 2 mL pre-warmed maintenance medium until all tissues were dosed and rinsed. Subsequently the skin tissues were incubated for approximately 44 hours at 37°C.

After incubation, cell culture inserts were dried carefully to remove excess medium and were transferred into a 12-wells plate prefilled with 2 mL MTT-medium (0.3 mg/mL). The tissues were incubated for 3 h at 37°C. The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate.
Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. Skin irritation potential of the test substance was classified according to remaining cell viability following exposure of the test substance.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: tissue viability

Value:

103

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 44 h. Reversibility: other: not applicable. (migrated information)

In vivo

Irritant / corrosive response data:

The tissue viability after treatment with the test substance was 103% compared to the negative control.

Other effects:

not applicable

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

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

Conclusions:

Aluminium trilactate is not irritating in the in vitro skin irritation test under the experimental conditions described in this report.

Executive summary:

In a dermal irritation study according to OECD Guideline 439 (In Vitro Skin Irritation), adopted 22 July 2010 and EU method B.46 (In vitro skin irritation: reconstructed human epidermis model test), 24 August 2009, Aluminium trilactate (93.0% a.i) was applied for 15 min to athree-dimensional human epidermis model (EPISKIN, SkinEthic Laboratories).

After the exposure period of 15 minutes at room temperature, the tissues were washed with phosphate buffered saline to remove residual test substance. Subsequently the skin tissues were incubated for approximately 44 h at 37°C. Cytotoxic (irritancy) was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.

The relative mean tissue viability obtained after 15 minutes treatment with Aluminium trilactate compared to the negative control tissues was 103%.

Since the mean relative tissue viability for the test substance was above 50% after 15 minutes treatment, Aluminium trilactate is considered to be not irritating.