Cyclohexanediacetic acid

Skin irritation / corrosion

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

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

Test material information

Constituent 1

Reference substance name:

Cyclohexanediacetic acid

EC Number:

224-427-9

EC Name:

Cyclohexanediacetic acid

Cas Number:

4355-11-7

Molecular formula:

C10H16O4

IUPAC Name:

2-[1-(carboxymethyl)cyclohexyl]acetic acid

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.