[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-06-12 till 2008-06-16

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 423 (In vitro skin corrosion: Human Skin Model Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

- public name of test material:
Reaction mass of 6,13-dichloro-3,10-bis{[2-({[(2-chloroethyl)sulfonyl]alkanoyl}amino)ethyl]-amino}- polycarboheterocyclo 4,11-disulfonic acid, mono and/or disodium salt and 6,13-dichloro-3-{[2-({[(2-chloroethyl)sulfonyl]alkanoyl}amino) ethyl]amino}-10-[(2-{[4-(ethenylsulfonyl)alkanoyl]amino}ethyl)amino] polycarboheterocyclo -4,11-disulfonic acid, mono and/or di sodium salt
- Physical state: solid, dark blue powder
- Analytical purity: approx. 86.6%
- Lot/batch No.: VER 2108 BOP 02/07
- Expiration date of the lot/batch: November 30, 2012

Test animals

Species:

other: human skin model: EpiDerm(TM)

Strain:

other: human skin model: EpiDerm(TM)

Details on test animals or test system and environmental conditions:

not applicable, in vitro test

Test system

Type of coverage:

other: not applicable, in vitro test

Preparation of test site:

other: not applicable, in vitro test

Vehicle:

other: not applicable, in vitro test

Controls:

other: not applicable, in vitrot test

Amount / concentration applied:

25 mg of test item

Duration of treatment / exposure:

2 treatment intervals: 3 minutes and 1 hour

Number of animals:

not applicable, in vitro test

Details on study design:

Duplicate EpiDerm™ tissues were treated with the test item, positive, and negative
controls for 2 different treatment intervals: 3 minutes and 1 hour.
After pre-incubation of EpiDerm™ tissues was completed (1 hour 15 minutes for the 3
minutes treatment, 1 hour 5 minutes for the 1 hour treatment) medium was replaced by
0.9 mL fresh assay medium in all four 6-well plates. 50 μL deionised water (negative
control) were added into the first insert atop the EpiDerm tissue. The procedure was
repeated with the second tissue. It was proceeded with test item and the positive control
in the same manner until all tissues of the same treatment interval were dosed. The 6-well
plates were placed into the incubator (37 ± 1.5 °C, 5 ± 0.5% CO2).
After the end of the treatment interval the first insert was removed immediately from the 6-
well plate. Using a wash bottle the tissue was gently rinsed with PBS to remove any
residual test material. Excess PBS was removed by gently shaking the insert and blotting
the bottom with blotting paper. The insert was placed in the prepared holding plate. It was
proceeded with test

Results and discussion

In vivo

Irritant / corrosive response data:

In the present study the test item test material was tested for its potential to induce
skin corrosion in a human skin model. The test allows the discrimination between
corrosive and non-corrosive chemical substances and mixtures. It does not provide
information on skin irritation, nor does it allow the subcategorisation of corrosive
substances according to GHS.

Any other information on results incl. tables

Results after Treatment with test material

Dose group	Treat-ment Interval	Absorbance 570 nm Tissue 1*	Absorbance 570 nm Tissue 2*	Mean Absorbance of 2 Tissues	Rel. Absorbance [% of Negative Control]**
Negative Control	3 min	1.375	1.338	1.356	100.0
Positive Control	3 min	0.258	0.278	0.268	19.8
FAT 40841/A TE	3 min	1.410	1.254	1.332	98.2
Negative Control	1 hour	1.411	1.341	1.376	100.0
Positive Control	1 hour	0.111	0.120	0.115	8.4
FAT 40841/A TE	1 hour	1.261	1.393	1.327	96.5

* Mean of three replicate wells after blank correction

** relative absorbance [rounded values]: 100 x (absorbancetest item) / (absorbancenegative control)

Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent blue colour could not be observed, since the test item was strongly coloured by itself.

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Conclusions:

It can be stated that in this study (human skin model) and under the experimental conditions
reported, the test item test material is non corrosive to skin.

Executive summary:

This in vitro study was performed to assess the corrosive potential of test material by means of the Human Skin Model Test.

Two tissues of the human skin model EpiDerm™ were treated with either the test item, the negative or the positive control for 3 minutes and 1 hour, respectively.

About 25 mg of the test item were applied to each tissue, wetted with 25 μL deionised water, and spread to match the tissue size. 50 μL of either the negative control (deionised water) or the positive control (8.0 N KOH) were applied to each tissue. After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD ≥ 0.8 for both treatment intervals thus showing the quality of the tissues.

Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control both for the 3 minutes treatment interval and for the 1 hour treatment interval thus ensuring the validity of the test system.

After treatment with the test item test material the relative absorbance values were not relevantly decreased both after 3 minutes and after 1 hour treatment. Therefore, the test item is not considered corrosive.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item test material is non corrosive to skin.