Indium trihydroxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Version / remarks:

version 13 April 2004

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Indium trihydroxide

EC Number:

243-947-7

EC Name:

Indium trihydroxide

Cas Number:

20661-21-6

Molecular formula:

H3InO3

IUPAC Name:

indium trihydroxide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Product name: Indium trihydroxide
Molecular Formula: In(OH)3
Batch number: OH-1306
CAS number: 20661-21-6
Appearance: white, powder
Expiry date: 02 November 2013
Storage conditions: Room Temperature, in the dark
Safety Precautions: Routine safety precautions (gloves, goggles, face mask, lab coat) for unknown materials were applied to assure personnel health and safety.

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

skin obtained from plastic surgery from multiple donors

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN-SM (Manufacturer: SkinEthic, France, Catalogue Number: EPISKIN/S/13
- Tissue batch number(s): 11-EKIN-042
- Expiry date: 21 November 2011
- Date of initiation of testing: 17 November 2011

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 18-28°C
- Temperature of post-treatment incubation (if applicable): not applicable

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 1wahsing step: rinsing thoroughly with PBS 1x solution (0.9%)

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 2.2 mL of 0.3 mg/mL MTT
- Incubation time: 3h
- Spectrophotometer: 96-well plate spectrophotometer
- Wavelength: 540nm

NUMBER OF REPLICATE TISSUES:3

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE (see any other info on mat and meth)


PREDICTION MODEL / DECISION CRITERIA (choose relevant statement):

- The test substance is considered to be corrosive to skin, if the mean relative viability after 4 hours of exposure is below 35% of the negative control.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg

VEHICLE
- Amount(s) applied (volume or weight with unit): na; no formulation was required

NEGATIVE CONTROL: NaCI (9 g/l saline)
- Concentration (if solution): 50µl

POSITIVE CONTROL: glacial acetic acid
- Concentration (if solution): 50µl

Duration of treatment / exposure:

4h

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: % viability

Run / experiment:

1

Value:

96

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

The results of the optical density (OD) measured at 540 nm of each extract and the calculated % viability of the cells is presented below:

 

Substance	Optical Density (OD)		Viability (%)
Negative Control: NaCl (9g/L saline)	1	0.208	100
	2	0.188
	3	0.192
	mean	0.196
Positive Control: Glacial acetic acid	1	0.011	6
	2	0.008	4
	3	0.025	13
	mean	0.015	8
Test Item: Indium trihydroxide	1	0.195	99
	2	0.191	98
	3	0.181	92
	mean	0.189	96

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this in vitro EPISKIN model test with Indium trihydroxide, the results indicate that the test item is not a skin corrosive.

Executive summary:

Disks of EPISKIN (three units / chemical) were treated with test item Indium trihydroxide and incubated for 4 hours at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution (0.9 %). The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution. The formazan precipitated was then extracted using acidified isopropanol and quantified spectrophotometrically. NaCI (9 g/l saline) and glacial acetic acid treated epidermis were used as negative and positive controls respectively. For each treated tissue viability was expressed as a % relative to negative control.

The test substance is considered to be corrosive to skin, if the mean relative viability after 4 hours of exposure is below 35% of the negative control.

The test item did not show significantly reduced cell viability in comparison to the negative control. All test item results were far above 35% of the mean negative control value.

In this in vitro EPISKIN model test with Indium trihydroxide, the results indicate that the test item is not a skin corrosive.