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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
Reference substance name:
Indium trichloride
EC Number:
233-043-0
EC Name:
Indium trichloride
Cas Number:
10025-82-8
Molecular formula:
Cl3In
IUPAC Name:
indium trichloride
Details on test material:
Name of test material: Indium trichloride
Chemical name: Indium(III) chloride
Molecular formula: InCl3
Batch number: ICsub-28
Physical state: white crystalline 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 / 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

Results and discussion

In vitro

Resultsopen allclose all
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

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

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.

Applicant's summary and conclusion

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.