Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-01-22 to 2015-03-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
Principles of method if other than guideline:
In vitro; highly differentiated 3D tissue model consisting of normal, human-derived epidermal keratinocytes
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): Tantalum pentachloride
- Physical state: solid
- Analytical purity: 99.9 %
- Lot/batch No.: 144217
- Expiration date of the lot/batch: 2016-05-11
- Storage condition of test material: at room temperature, protected from humidity
- Other: Hydrolysis in water at room temperature

Test system

Type of coverage:
open
Preparation of test site:
other: dried thoroughly by patting
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20+/- 2 mg (52.6 mg/cm²)

VEHICLE
- No vehicle due to the instability of the test substance in the presence of water
Duration of treatment / exposure:
3 min, 1 and 4 h
Observation period:
not applicable
Number of animals:
not applicable
Details on study design:
TEST SITE
- Area of exposure: directly atop

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 15 times with 25 ml PBS
- Time after start of exposure: 3 min, 1 h and 4 h

SCORING SYSTEM:
Corrosivity potential of the test item will be predicted from the relative mean tissue viabilities obtained after 3 min, 1 h and 4 h treatment compared to the negative control tissues concurrently treated with 0.9% NaCl solution (=100%).
A test item is classified "non-corrosive" if relative tissue viability after 4 h treatment is not decreased to less than 35 % of the corresponding negative control tissues.
A test item is classified "corrosive" (in accordance with UN GHS "Category 1") in any case, if the relative tissue viability after 4 h treatment is decreased below 35%; if viability is reduced to less than 35% after 4 h treatment and to more than 35% after 1 h treatment, or to less than 35% viability after 1 h but not more than 35% after 3 min treatment, the test item is classified as corrosive, in accordance with optional UN GHS sub-category 1b/C.
A test item with decreases viability below 35% after 3 min treatment is classified as corrosive in accordance with optional UN GHS sub-category 1A.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: other: mean relative tissue viability [%]
Value:
74
Remarks on result:
other:
Remarks:
Basis: mean duplicates. Time point: 3 min. Max. score: 100.0. Remarks: max score = 100 % viability, obtained by negative control. (migrated information)
Irritation / corrosion parameter:
other: other: mean relative tissue viability [%]
Value:
29
Remarks on result:
other:
Remarks:
Basis: mean duplicates. Time point: 1 h. Max. score: 100.0. Remarks: max score= 100% viability, obtained by negative control. (migrated information)
Irritation / corrosion parameter:
other: other: mean relative tissue viability
Value:
4
Remarks on result:
other:
Remarks:
Basis: mean duplicates. Time point: 4 h. Max. score: 100.0. Remarks: max score = 100% viability, obtained by negative control. (migrated information)
Irritation / corrosion parameter:
other: other: mean relative tissue viability [%]
Value:
5
Remarks on result:
other:
Remarks:
Basis: mean duplicates. Time point: 4h. Max. score: 100.0. Remarks: positive control; max score= 100% viability, obtained by negative control. (migrated information)

Any other information on results incl. tables

Pre-Experiments:

The mixture of 20 mg Tantalum pentachloride per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The medium turned yellow and insoluble residues of the test item were observed. The test item was coloured slightly pink but the mixture did not turn blue/purple.

The mixture of 10 mg Tantalum pentachloride per 300 mL water showed no colouring as compared to the solvent.

Results of the experiment:

Table 1: Results of 3 min. Experiment

Name

Negative Control

Test Item

Tissue

1

2

1

2

Absolute OD570– values (raw data)

1.118

0.999

0.793

0.807

1.102

0.965

0.765

0.794

Mean OD570
(mean of 2 aliquots per tissue)

1.110

0.982

0.779

0.800

Mean OD570
(blank corrected)

1.064

0.937

0.733

0.755

Total mean OD570
(mean of 2 replicate tissues, blank corrected)

1.000*

0.744

Relative tissue viability (%)

106.4

93.6

73.3

75.5

Mean relative tissue viability (%)

100

74

Difference of relative tissue viability (%)

12.8

2.2

* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability

*** difference between each two replicates is ≤ 30% (in the range of 20-100% viability and for ODs >0.3)

Table 2: Results of 60 min. Experiment

Name

Negative Control

Test Item

Tissue

1

2

1

2

Absolute OD570– values (raw data)

1.036

1.002

0.089

0.575

1.030

1.012

0.092

0.575

Mean OD570
(mean of 2 aliquots per tissue)

1.033

1.007

0.090

0.575

Mean OD570
(blank corrected)

0.988

0.961

0.045

0.530

Total mean OD570
(mean of 2 replicate tissues, blank corrected)

0.975*

0.287

Relative tissue viability (%)

101.3

98.7

4.6

54.3

Mean relative tissue viability (%)

100

29

Difference of relative tissue viability (%)***

2.7

49.7

* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability

*** difference between each two replicates is ≤ 30% (in the range of 20-100% viability and for ODs >0.3) – (criterion failed for the test item treated replicates)

               Table 3: Results of 4h Experiment

Name

Negative Control

Test Item

Positive Control

Tissue

1

2

1

2

1

2

Absolute OD570– values (raw data)

0.983

0.939

0.085

0.075

0.091

0.093

0.963

0.887

0.084

0.083

0.095

0.096

Mean OD570(mean of 2 aliquots per tissue)

0.973

0.913

0.084

0.079

0.093

0.094

Mean OD570(blank corrected)

0.927

0.867

0.039

0.034

0.047

0.049

Total mean OD570(mean of 2 replicate tissues, blank corrected)

0.897*

0.036

0.048

Relative tissue viability (%)

103.4

96.6

4.3

3.7

5.3

5.5

Mean relative tissue viability (%)

100

4

5**

Difference of relative tissue viability (%)***

6.7

0.6

0.2

* corrected mean OD570of the negative control corresponds to 100% absolute tissue viability

** mean relative tissue viability of the two positive control tissues of the 4h treatment period is ≤ 20%

*** difference between each two replicates is ≤ 30% (in the range of 20-100% viability and for ODs >0.3)

Table 4: Test acceptance criteria

 

value

cut off

pass/fail

Mean OD570 nmblank

0.046

<0.1

pass

Mean absolute OD570 nmNC
(4h experiment)

0.897

0.6-1.5

pass

Mean absolute OD570 nmNC
(60 min. experiment)

0.975

0.6-1.5

pass

Mean absolute OD570 nmNC
(3 min. experiment)

1.000

0.6-1.5

pass

Mean relative viability PC (%)
(4h experiment)

5%

≤20%

pass

Max. difference of tissue viability

49.7%

≤30%

fail

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tantalum pentachloride was classified as corrosive under conditions of a validated EPISKIN-SM in vitro test.
Executive summary:

In an in vitro skin corrosion study, the reconstituted three-dimensional human skin model EPISKIN-SMTM was topically exposed to 20 mg of Tantalum pentachloride (99.9%) for 3 min, 1 h and 4 h according to OECD guideline 431. After exposure the tissue was washed with PBS and tissue viability was assessed using the MTT reduction assay.

Physiological saline served as negative control, corresponding to 100 % tissue viability. As a positive control glacial acetic acid was used. Measurements were performed in duplicates and mean values were calculated.

In this study, Tantalum pentachloride is skin corrosive, based on a mean tissue viability of less than 35% after 60 min, but not after 3 min. Tantalum pentachloride is classified as corrosive in accordance with CLP sub-category 1B/C.