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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 7-8, 2010
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

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)

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids C10-20, reaction product with diethylenetriamine
EC Number:
940-308-0
IUPAC Name:
Fatty acids C10-20, reaction product with diethylenetriamine
Test material form:
liquid: viscous
Details on test material:
Test substance: Fatty acids, C10-20 neo, reaction product with diethylenetriamine
Old name of the test material: MK195KSF
Sample description: orange/brown hazy solid
Volatile: no
Storage conditions: at room temperature

Test system

Controls:
no
Duration of treatment / exposure:
3 and 60 minutes
Number of animals:
none

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: relative tissue viability (OD550)
Basis:
mean
Time point:
other: 3 min
Score:
1.639
Remarks on result:
other: 89%
Irritation parameter:
other: relative tissue viability (OD550)
Basis:
mean
Time point:
other: 60 min
Score:
1.408
Remarks on result:
other: 85%

Any other information on results incl. tables

3 min.

Negative control

Test item

Positive Control

Tissue 1

Tissue 2

Tissue 1

Tissue 2

Tissue 1

Tissue 2

absolute OD550-value

 

1.808

1.853

1.630

1.619

0.402

0.426

 

1.764

1.894

1.651

1.662

0.396

0.417

 

1.808

1.907

1.646

1.624

0.410

0.421

OD550

(mean of 3 aliquots)

1.793

1.885

1.642

1.635

0.403

0.421

OD550

(mean of 2 replicate tissue)

1.839*

1.639

0.412

Mean relativetissue viability[%]

100

89

22**

Inter tissue viability

difference [%]***

5.0

0.4

4.5

* mean OD550= 0.8

** mean relative tissue viability of the 3min. positive control =30%

*** inter tissue viability difference =30%

 

60 min.

Negative control

Test item

Positive Control

Tissue 1

Tissue 2

Tissue 1

Tissue 2

Tissue 1

Tissue 2

absolute OD550-value

 

1.667

1.678

1.524

1.267

0.183

0.183

1.681

1.679

1.536

1.290

0.185

0.186

1.651

1.641

1.551

1.280

0.185

0.182

OD550

(mean of 3 aliquots)

1.666

1.666

1.537

1.279

0.184

0.184

OD550

(mean of 2 replicate tissue)

1.666*

1.408

0.184

Mean relativetissue viability[%]

100

85

11

Inter tissue viability

difference [%]***

0.0

18.3

0.3

* mean OD550= 0.8

*** inter tissue viability difference =30%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance showed no corrosive effects