Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006/05/04-2006/07/31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was performed according to GLP and the methods applied are fully compliant with OECD TG 435.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Version / remarks:
(Corrositex)
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
N-butylpyridinium heptachlorodialuminate
IUPAC Name:
N-butylpyridinium heptachlorodialuminate
Details on test material:
Chemical Name: N-butylpyridinium heptachlorodialurninate
Description brown viscous liquid
Batch number C3319-I8
Date received 04 April 2006
Storage conditions room temperature in the dark, over silica gel, under nitrogen

Test animals

Species:
other: in vitro test
Strain:
other: in vitro test
Details on test animals or test system and environmental conditions:
NA

Test system

Type of coverage:
other: in vitro test
Preparation of test site:
other: in vitro test
Controls:
not required
Amount / concentration applied:
NA
Duration of treatment / exposure:
NA
Observation period:
NA
Number of animals:
NA
Details on study design:
NA

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: Breakthrough Time
Run / experiment:
1
Value:
32
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

In vivo

Irritant / corrosive response data:
NA
Other effects:
NA

Any other information on results incl. tables

  Vial 1  Vial 2  Vial 3  Vial 4 
Start time (hh:mm:ss)  00:00:00  00:06:00  00:07:00   00:08:00
Detection time (hh:mm:ss)  00:32:00  00:38:00  00:39:00   00:40:00
Breakthrough time (hh:mm:ss)  00:32:00  00:32:00  00:32:00   00:32:00

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: other: US DOT Packaging Group Criteria
Conclusions:
Under the conditions of the test the test material was considered to be CORROSIVE and assigned the US DOT Packing Group Criteria II. According to GHS criteria, the test material was considered to CORROSIVE and assigned to the corrosive subcategory 1B.
Executive summary:

Introduction.

The test material was assessed for its corrosivity potential using the CORROSITEX assay.

Method.

The assay consisted of::

I) a qualification screen with the Chemical Detection System

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

III) a definitive CORROSITEX assay

Results.

Sample qualified: YES

Sample category: I

Mean Breakthrough time: approximately 32 minutes

Conclusion.

Under the conditions of the test the test material was considered to be CORROSIVE and assigned the US DOT Packing Group Criteria II. According to GHS criteria, the test material was considered to CORROSIVE and assigned to the corrosive subcategory 1B.