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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

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

Materials and methods

Test guideline
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:
9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
EC Number:
272-379-2
EC Name:
9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
Cas Number:
68815-51-0
Molecular formula:
C18 H34 O2 . C4 H12 N2 O
IUPAC Name:
2-(2-aminoethylamino)ethanol; (Z)-octadec-9-enoic acid
Details on test material:
- Name of test material (as cited in study report): Kerocom F 100 Test-substance No.: 07/0395-1
- Analytical purity: 100%
- Purity test date: 18.06.07
- Lot/batch No.: GV33754-L2927
- Stability under storage conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: room temperature
- Homogeneity: The test substance was homogeneous by visual inspection.

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 min exposure
Value:
93
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1 h exposure
Value:
95
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Findings:

Exposure: 3 min

Test-article

OD570

tissue 1

OD570

tissue 2

OD570

kc

mean OD570

mean OD570

kc-corrected

viability [% of negative ctrl]

negative ctrl

1.950

1.688

0.136

1.819

-

100

07/0395-1

1.623

1.761

0.158

1.692

-

93

positive ctrl

0.289

0.444

-

0.366

-

20

kc: killed control for MTT reduction control

OD: optical density

Exposure: 1 h

Test-article

OD570

tissue 1

OD570

tissue 2

OD570

kc

mean OD570

mean OD570

kc-corrected

viability [% of negative ctrl]

negative ctrl

1.850

1.839

0.191

1.844

-

100

07/0395-1

1.788

1.700

0.181

1.744

-

95

positive ctrl

0.122

0.174

-

0.148

-

8

kc: killed control for MTT reduction control

OD: optical density

Due to the ability of the test substance to reduce MTT directly, a KC was introduced. However, the result of the KC did not indicate an increased MTT reduction; therefore the KC was not used for viability calculation.

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive