N-[3-({[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}methyl)-3,5,5-trimethylcyclohexyl]-2,2-dimethyl-3-(morpholin-4-yl)propan-1-imine

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2011-04-06 to 2011-05-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Version / remarks:

EU-Method B.40 BIS. „IN VITRO SKIN CORROSION: HUMAN SKIN MODEL TEST“ , 31 May 2008

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Version / remarks:

OECD 431; 13 April 2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

[2,2-dimethyl-3-(morpholin-4-yl)propylidene][(5-{[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}-1,3,3-trimethylcyclohexyl)methyl]amine

EC Number:

700-584-3

Cas Number:

1217271-02-7

Molecular formula:

C28H52N4O2

IUPAC Name:

[2,2-dimethyl-3-(morpholin-4-yl)propylidene][(5-{[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}-1,3,3-trimethylcyclohexyl)methyl]amine

Test material form:

other: liquid

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

Amount/concentration applied:

50 µL of the liquid test item were applied to each tissue and spread to match the tissue size.

Duration of treatment / exposure:

3 minutes and 1 hours.

Results and discussion

In vitro

Results

Remarks on result:

no indication of irritation

Remarks:

Sika Hardener MI was not considered corrosive in the Human Skin Model Test.

Other effects / acceptance of results:

After three minutes treatment with the test item, the relative absorbance values were reduced to 82.3 %. This value is well above the threshold for corrosion potential (50 %). After one hour treatment, relative absorbance values were reduced to 42.5 %. This value, too, is well above the threshold for corrosion potential (15 %). Therefore, Sika Hardener MI was not considered corrosive in the Human Skin Model Test.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Sika Hardener MI was not considered corrosive in the Human Skin Model Test.

Executive summary:

The determination of Skin Corrosion Potential of Sika Hardener MI was performed in the Human Skin Model Test following OECD Guideline 431 and EU Method B.40-BIS. One valid experiment was performed. Two tissues of the human skin model EpiDermTM were treated with Sika Hardener MI for three minutes and one hour, respectively. 50 µL of the liquid test item were applied to each tissue and spread to match the tissue size. Deionised water was used as negative control, 8 M KOH was used as positive control.

After three minutes treatment with the test item, the relative absorbance values were reduced to 82.3 %. This value is well above the threshold for corrosion potential (50 %). After one hour treatment, relative absorbance values were reduced to 42.5 %. This value, too, is above the threshold for corrosion potential (15 %). Therefore, Sika Hardener MI was not considered corrosive in the Human Skin Model Test.