Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 22, 2010 to October, 18, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted GLP guideline study
Cross-reference
Reason / purpose:
reference to same study

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:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: ICCVAM Minimum Performance Standards: In vitro Membrane Barrier Test Systems for Skin Corrosion, June 23, 2003
Deviations:
no
Qualifier:
according to
Guideline:
other: ICCVAM Recommended Performance Standard for in vitro Test Methods for Skin Corrosion (May 2004)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Details on test animals and environmental conditions:
TEST SYSTEM
- test kit: Name: Corrositex™
Supplier: Transia GmbH, 61239 Ober-Mörlen, Germany
Catalogue No.: 99302
Lot No.: CT040110
- preparation of the bio-barrier: Preparation of the bio-barrier matrix was completed one day prior to testing and stored at 4 -8 °C until assay performance. The bio-barrier powder was solved in the bio-barrier diluent and heated for 20 +/- 2 minutes at 68 – 70 °C in a water bath under continuous stirring. The temperature did not exceed 70 °C. The mixture was allowed to cool in the turned-off water bath for another 10 minutes. The mixture was then filled into the membrane holders, 200 μL per membrane holder. Air bubbles were avoided. The filled membrane holders were sealed with parafilm and were stored at 4 – 8 °C until further use.

Test system

Amount / concentration applied:
500 µL applied per bio-barrier
Duration of treatment / exposure:
1 - 4 hours
Number of animals:
Not applicable

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Remarks on result:
other:
Remarks:
Basis: other: Test item. Time point: 77 minutes 41 seconds. Remarks: DOT Packing group III; R34; GHS 1C. (migrated information)
Irritation / corrosion parameter:
other:
Remarks on result:
other:
Remarks:
Basis: other: Positive control. Time point: 1 minute 7 seconds. Remarks: DOT Packing group I; R35, GHS 1A. (migrated information)
Irritation / corrosion parameter:
other:
Remarks on result:
other:
Remarks:
Basis: other: Negative control. Remarks: Colour change was not observed after 240 minutes. (migrated information)

In vivo

Irritant / corrosive response data:
The test item was classed corrosive

Any other information on results incl. tables

Qualify test

The test item induced a change in colour in the qualify test after 1 minute incubation. Since a change in colour was visible in the “Qualify Test Vial”, the test item was considered to be suitable for the next step.

Categorisation Test

The test item induced a change in colour in the Category B vial but not in the Category A vial after 1 minute incubation. Therefore, the test item was classified as category I.

Classification Test

Test Group

Time to colour change (minutes)

DOT Packing Group

R-Sentence

GHS

Negative Control

Colour change was not observed after 240 minutes

-

-

-

Positive Control

1 minutes 7 seconds

I

R35

1A

Test Item

77 minutes 41 seconds

III

R34

1C

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions reported, the test item is corrosive to skin and classified in Category 1C according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and C; R34 according to the criteria of the Council Directive 67/548/EEC (and subsequent adaptations).
Executive summary:

An in vitro study was performed to assess the corrosive potential of the test item by means of the In Vitro Membrane Barrier Test for Skin Corrosion using the Corrositex™ test kit.

The test item passed the qualify test and was considered as suitable for testing with the Corrositex™ test kit.

The test item induced a colour change in the category B vial, but not in the Category A vial after 1 minute incubation. Therefore, the test item was classified according to category I.

500 μL of the test item were applied on quadruplicate bio-barriers for the classification test. The bio-barriers were placed at top vials containing the CDS reagent. The time needed to corrode the bio-barrier and induce a distinct change in the colour of the CDS reagent was monitored for each of the vials.

500 μL of the negative control (10% citric acid) or 500 µL the positive control (Sulfuric acid 95-98%) was placed atop one bio-barrier and the colour change of the CDS reagent was monitored up to 240 minutes. The negative control did not induce a change in the colour of the CDS reagent after 240 minutes. The positive control showed a distinct change in the colour of the CDS reagent after 1minute 7 seconds incubation. These results ensured the validity of the test.

 

The mean time needed to change the colour of the CDS reagent after treatment of the bio-barriers with the test item was 77 minutes 41 seconds leading to conclusion as corrosive.

 

In conclusion, under the experimental conditions reported, the substance is corrosive to skin, and classified in Category 1C according to the criteria of the Regulation (EC) N°1272/2008 (CLP) and C; R34 according to the criteria of the Council Directive 67/548/EEC (and subsequent adaptations).

This study is considered as acceptable as it satisfied the criteria of OECD guidelines for skin irritation/corrosivity.