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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-02-27 till 2008-03-03
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: OECD 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
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 40840/A TE
- Substance type: colouring dye
- Physical state: solid, dark red powder
- Analytical purity: approx. 78.9% org. part (NA-salt), MC: 37.7%, Oligomers: 19.2%
- Lot/batch No.: ROE 358 BOP 01/07
- Expiration date of the lot/batch: June 30, 2012
- Storage condition of test material: At room temperature at about 20°C

Test animals

Species:
other: human skin model: EpiDerm
Details on test animals 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:
not required
Amount / concentration applied:
25 mg of test item
Duration of treatment / exposure:
2 treatment intervals: 3 minutes
1 hour
Number of animals:
no animals
Details on study design:
After pre-incubation of EpiDerm™ tissues was completed (1 hour for each 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 item and the positive control in the same manner until all EpiDerm™
tissues were dosed.

Results and discussion

In vivo

Irritant / corrosive response data:
In the present study the test item FAT 40840/A TE 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 FAT 40841/A TE:

 Dose group  Treatment Interval  Absorbance 570nm Tissue 1*  Absorbance 570 nm Tissue 2*  Mean Absorbance of 2 Tissues  Rel.Absorbance (% of negative control)**
 Negative Control  3 min  1.777  1.739  1.758  100.0
 Positive Control  3 min  0.325  0.444  0.385  21.9
 FAT 40840/A TE  3 min  1.535  1.509  1.522 86.6 
 Negative Control  1 hour  1.612  1.454  1.533  100.0
 Positive Control  1 hour  0.120  0.130  0.125  8.2
 FAT 40840/A TE  1 hour  1.253  1.040  1.147  74.8

* Mean of three replicate wells after blank correction

** relative absorbance (rounded values): 100 x (absorbance testitem) / (absorbance negativ control)

Optical evaluation of tje MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue color

Applicant's summary and conclusion

Interpretation of results:
other: non corrosive
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item FAT 40840/A TE is non corrosive to
skin.
Executive summary:

This in vitro study was performed to assess the corrosive potential of FAT 40840/A TE 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 FAT 40840/A TE the relative absorbance values were

decreased to 86.6% after 3 minutes treatment. After 1 hour treatment relative absorbance

values were reduced to 74.8%. Both values are well above the threshold for corrosivity

(50% for 3 minutes treatment and 15% for 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 FAT 40840/A TE is non corrosive to skin.