Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the current OECD 435 guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test system

Duration of treatment / exposure:
from 0 to 240 minutes

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other:
Remarks on result:
other:
Remarks:
Remarks: fields not applicable for Corrositex test. (migrated information)

In vivo

Irritant / corrosive response data:
mean breakthrough time: 6 minutes 50 seconds

Any other information on results incl. tables

Qualification screen: the test item produced an immediate colour change and therefore qualified for use in the CORROSITEX assay.

results:

 

Test Item Breakthrough Time

 

Vial 1

Vial 2

Vial 3

Vial 4

Start Time (hr:min:sec)

00:02:00

00:06:00

00:07:00

00:08:00

Detection Time (hr:min:sec)

00:10:30

00:12:10

00:14:00

00:14:40

Breakthrough Time (hr:min:sec)

00:07:30

00:06:10

00:07:00

00:06:40


hr=    hour(s)

min =  minute(s)

sec =  second(s)

Mean Breakthrough time of the four test item replicates:       6 minutes 50 seconds

CORROSITEX CLASSIFICATION:                    CORROSIVE PACKING GROUP II.

The results of the assay were accepted on condition of adherence to the positive and negative control item ranges given in the following table:

 

Chemical

Concentration
(weight %)

Breakthrough Time (hr:min:sec)

Positive Control

Sulphuric Acid

95 – 98

00:00:52

Negative Control

Citric Acid

10

No breakthrough observed

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Executive summary:

The test item was assessed for its corrosivity potential using the CORROSITEX assay. The method was designed to be compatible with the following: OECD Guidelines for the Testing of Chemicals No. 435 “In VitroMembrane Barrier Test Method for Skin Corrosion” (adopted 19 July 2006).

The assay consisted of:

a qualification screen with the Chemical Detection System

a categorisation screen to identify test items as having either a high or low acid/alkaline reserve

a definitive CORROSITEX assay

Results:

Sample qualified:  YES / Sample category:  1

Mean Breakthrough time  :   6 minutes 50 seconds

Conclusion: The test item was considered to be CORROSIVE and can be assigned the UN Packing Group Criteria II.