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Description of key information

In the in vitro EPISKIN model test, Indium trichloride did not show significantly reduced cell viability in comparison to the negative control after 3 minutes and 1 hour exposure. All indium trichloride results were above 35% of the mean negative control value. Indium trichloride showed significantly reduced cell viability in comparison to the negative control (< 35 %) after four hours exposure (Kiss, 2012)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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 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 / 12-EKIN-005
- Expiry date: 21 November 2011 / 06 February 2012
- 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:
3 minutes, 1 hour and 4 hours
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
4h time point
Value:
10
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1h time point
Value:
68
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 min time point
Value:
87
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

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

Exposure time

Optical Density (OD)

OD after adjustment*

Viability (%)

Negative Control:

4 hours (Day 0)

1

0.208

 

100

NaCI (9 g/l saline)

2

0.188

 

3

0.192

 

mean

0.196

 

1 hour (Day 76)

1

0.156

 

100

2

0.155

 

3

0.179

 

mean

0.163

 

Positive Control:

4 hours (Day 0)

1

0.011

 

6

Glacial acetic acid

2

0.008

 

4

3

0.025

 

13

mean

0.015

 

8

1 hour (Day 76)

1

0.021

 

13

2

0.035

 

21

3

0.010

 

6

mean

0.022

 

13

Test Item:

4 hours (Day 0)

1

0.035

0.016

8

Indium trichloride

2

0.043

0.024

12

3

0.038

0.019

10

mean

 

0.020

10

1 hour (Day 76)

1

0.147

0.116

71

2

0.097

0.066

40

3

0.181

0.150

92

mean

 

0.111

68

3 minutes (Day 76)

1

0.159

 

98

2

0.141

 

87

3

0.126

 

77

mean

0.142

 

87

 

*For the test item, the material had a residual colour which was expected to cause an OD of 0.019 and 0.031 after 4 hours and 1 hour exposure in the final solutions. This was subtracted from the measured OD values.

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
In this in vitro EPISKIN model test with Indium trichloride, the results indicate that the test item is corrosive after 4 hours exposure and not corrosive after 3 minutes and 1 hour exposure. The test item should be classified as Corrosive GHS Class 1C.


Executive summary:

Disks of EPISKIN were treated with test item Indium trichloride and incubated for3 minutes, 1 hour and 4 hoursat room temperature.The viability of each disk was assessed by quantification of formazan precipitate after incubation in MTT solution.NaCI (9 g/l saline) and glacial acetic acid treated epidermis were used as negative and positive controls respectively.An additional disk was used to provide an estimate of colour contribution from the test item.For each test item treated disk,Optical Density (OD)was calculated and the tissue viability was expressed as a % relative to negative control.

The test item did not show significantly reduced cell viability in comparison to the negative control after 3 minutes and 1 hour exposure. All test item results were above 35% of the mean negative control value.

The test item showed significantly reduced cell viability in comparison to the negative control (< 35 %) after four hours exposure.

All validity criteria were within acceptable limits and therefore the study can be considered as valid.

In this in vitro EPISKIN model test with Indium trichloride, the results indicate that the test item is corrosive after 4 hours exposure and not corrosive after 3 minutes and 1 hour exposure. The test item should be classified as Corrosive GHS Class 1C.


 

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The results of Kiss I, 2012, indicate with the in vitro EPISKIN model test that indium trichloride is corrosive after 4 hours exposure and not corrosive after 3 minutes and 1 hour exposure.

This is confirmed by the Szakmary et al 2001 study, which evaluated according to OECD guideline 404, the skin irritation potential of indium trichloride in 3 male New Zealand White rabbits. The dose level of 500mg of indium chloride applied on an intact, and clean-shaven skin surface for 4h, caused severe irreversible dermal damages, i.e. it proved to be irritative and corrosive. Observations were made 1, 24, 48 and 72 h after exposure.

Justification for classification or non-classification

Indium trichloride is corrosive after 4 hours exposure and not corrosive after 3 minutes and 1 hour exposure and should therefore be classified as Corrosive GHS Class 1C.