Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD guideline 431 and EC method B40

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
GLP compliance:
yes (incl. QA statement)
Remarks:
Harlan cytotest cell research GmbH

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
orange solid powder

Test animals

Details on test animals or test system and environmental conditions:
Human skin model test.

Test system

Amount / concentration applied:
25 mg test material per tissue.
Duration of treatment / exposure:
3 minutes and 1 hour.

Results and discussion

In vivo

Results
Irritation parameter:
other: Relative absorbance
Basis:
mean
Time point:
other: 3
Score:
> 50
Max. score:
80
Reversibility:
no data
Remarks on result:
other: In vitro study
Irritant / corrosive response data:
Not corrosive to skin according UN GHS / EU CLP Cat.1 / DSD

Any other information on results incl. tables

 Dose group  Exposure 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  1.345  1.377  1.361  100
 Positive control  3 min  0.073  0.090  0.081  6.0
 D-100  3 min  1.074  0.904  0.989  72.7
           
Negative control   1 hour 1.152  1.229  1.190  100.0
 Positive control  1 hour  0.021  0.011  0.016  1.3
 D-100  1 hour  1.005  0.916  0.960  80.7
           

* Mean of three replicate wells after blank correction

**relative absorbance: = 100 x (absorbance of test item)/ (absorbance of negative control)

The optical evaluation of the MTT-reducing capacity of the test item after one hour incubation with MTT-reagent did not show evidence of a blue colour and thereby was not considered to be a MTT reducer.

The test item D-100 is considered to be non-corrosive to skin:

- since the viability after 3 minutes exposure is greater than 50 % and

- the viability after 1 hour exposure is greater than 15%.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Not corrosive to skin according UN GHS / EU CLP Cat.1 / DSD
Executive summary:

This in vitro study was performed to assess the corrosive potential of D-100 by means of the Human Skin Model Test. Independent duplicate tissues of the human skin model EST-1000™ were exposed to the test item, the negative control or the positive control for 3 minutes and 1 hour, respectively. About 25 mg of the solid test material were applied to the tissues and wetted with 50 μL deionised water. A volume of 50 μL of either the negative control (deionised water) or the positive control (8.0 N KOH) was applied to each tissue. After exposure to the negative control the absorbance values exceeded the required acceptability criterion of mean OD570 ≥ 0.8 for both treatment intervals thereby confirming the acceptable quality of the tissues. Exposure to the positive control induced a decrease in the relative absorbance as compared to the negative control, both for the 3 minutes exposure period and for the 1 hour exposure period thus confirming the validity of the test system. After exposure to the test item D-100 the relative absorbance values decreased to 72.7% after 3 minutes. After the 1 hour exposure relative absorbance values were reduced to

80.7%. Nevertheless, both values are well above the threshold of 50% for the 3 minutes exposure and above 15% for the 1 hour exposure. Therefore, the test item was considered to be not corrosive. In conclusion, it can be stated that in this study and under the reported experimental conditions, the test item D-100 was non corrosive to skin according to UN GHS / EU CLP Cat.1 / DSD (67/548/EEC).