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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
Study period:
13 June 2017 - 20 July 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Version / remarks:
July 29, 2016
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized
EC Number:
308-415-1
EC Name:
9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized
Cas Number:
97953-16-7
IUPAC Name:
9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
unchanged (no vehicle)
Details on test system:
EpiDerm™ Kit
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
25 ± 2 mg (39.7 mg/cm2 according to guideline)
Duration of treatment / exposure:
3 min or 1 hour
Number of replicates:
Duplicate

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 minute exposure
Value:
107.1
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:
1 hour exposure
Value:
92.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
The acceptance criteria are met:

• the mean OD of the tissue replicates treated with the negative control is ≥ 0.8 and ≤ 2.8 for every exposure time (range: 1.369 to 1.766)
• the mean viability of the tissue replicates treated with the positive control for 1 hour, is <15% compared to the negative control (4.8%)
• the Coefficient of Variation (CV) in the range 20 – 100% viability between tissue replicates is ≤ 30% (range: 2.5% to 9.1%)

Any other information on results incl. tables

Results after treatment with the substance and the controls

 

Dose

Group

 

Exposure

Interval

 

Mean Absorbance

(OD) of 2

Tissues

 

CV

[%]

Mean Rel.

Absorbance

[%]**

 
 

Negative

Control

 3 minutes  1.388    
 

Positive

Control

   0.298    
 Test Item    1.487    
  

Negative

Control

 60 minutes 1.683     
  

Positive

Control

   0.080    
  Test Item    1.553    

3 Minutes Treatment Historical Data:

 Positive Control    Negative Control  
 Mean Viability [%]  22.65  Mean OD  1.67
 Stand. Dev.  8.84  Stand. Dev.  0.13
 Range of Viabilities [%]  4.60 – 39.83  Range of ODs  1.34 – 1.93

60 Minutes Treatment Historical Data:

 Positive Control    Negative Control  
 Mean Viability [%]  6.72  Mean OD  1.64
 Stand. Dev.  3.01  Stand. Dev.  0.15
 Range of Viabilities [%]  2.30 – 14.77  Range of ODs 1.32 – 1.85

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not considered to be corrosive.
Executive summary:

An in vitro study was performed to assess the corrosive potential of the substance by means of the Human Skin Model Test with EpiDerm™ tissues models. 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 (21.4%) and for the 1 hour exposure period 4.8%) thus confirming the validity of the test system and the specific batch of tissue models. After 3 minutes exposure to the substance the relative absorbance value was not reduced (107.1%). After 1 hour exposure the relative absorbance value decreased to 92.3%. Both values did not exceed the threshold for corrosivity which is defined to be 50% after the 3 minutes exposure and 15% after the 1 hour exposure. Therefore, the substance is not considered to be corrosive.

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