Registration Dossier

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:
2010
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Principles of method if other than guideline:
Commercial name: CORROSITEX ®
Supplier: InVitro INTERNATIONAL
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The membrane barrier (biobarrier) consists of two components: a proteinaceous macromolecular aqueous gel and a permeable supporting membrane. The proteinaceous gel should be impervious to liquids and solids but it could be corroded and made permeable.
The proteinaceous gel serves as the target for the test item and is placed on the surface of the supporting membrane and is allowed to gel, prior to placing the membrane barrier over the indicator solution.
The proteinaceous gel should be of equal thickness and density on the entire surface and with no air bubbles or defects that could affect its functional integrity.
The permeable supporting membrane provides mechanical support to the proteinaceous gel during the gelling process and exposure to the test item. The supporting membrane prevents sagging or shifting of the gel and is readily permeable to all test substances.

Results and discussion

Any other information on results incl. tables

The results of main assay are showed in Table:

Test or control item

Sample code

Chemical/physical change

Breakthrough observation time (min)

 

Value

observed

Mean ± SD

 

CYCLOHEXANEDIACETIC ACID

 

1

No change

65.00

N/A

2

No change

65.00

3

No change

60.00

4

No change

65.00

Valeroyl Chloride

 

+

Colour change: red

11.97

N/A

Citric Acid 10%

 

-

No change

60.00

N/A

The test item did not show the ability to pass the membrane in the four replicates within the maximum observation time (65 minutes).

Positive and negative control results indicated a good functioning of the test system.

Positive control was corrosive at 11.97 minutes, in agreement with the RTC historical control value.

Negative control was not corrosive at 60 minutes.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test item is not defined as corrosive to the skin.