Indium trinitrate

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:

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 trinitrate

EC Number:

237-393-5

EC Name:

Indium trinitrate

Cas Number:

13770-61-1

Molecular formula:

HNO3.1/3In

IUPAC Name:

indium(3+) trinitrate

Details on test material:

Product name: Indium trinitrate
Synonym: Indium nitrate solid
Molecular formula: In(NO3)3.xH2O
Batch number: SD6039
CAS number: 13770-61-1
Appearance: white to off-white, granular
Expiry date: 03 February 2013
Storage conditions: Room Temperature, beside silica
Safety Precautions: Routine safety precautions (gloves, goggles, face mask, lab coat) for unknown materials were applied to assure personnel health and safety.

The pH of Test Item was measured as 3.5.

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): 12-EKIN-015
- Expiry Date: 16 April 2012
- Date of initiation of testing: 12 April 2012

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:

% tissue viability

Run / experiment:

1

Value:

78

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)		OD after adjustment*	Viability (%)
Negative Control: NaCl (9g/L saline)	1	0.315		100
	2	0.238
	3	0.206
	mean	0.253
Positive Control: Glacial acetic acid	1	0.015		5.9
	2	0.035		14
	3	0.013		5.1
	mean	0.021		8.3
Test Item: Indium trinitrate	1	0.239	0.202	80
	2	0.234	0.197	78
	3	0.229	0.192	76
	mean	0.234	0.197	78

 

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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