Registration Dossier
Registration Dossier
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EC number: 233-058-2 | CAS number: 10026-11-6
Skin irritation / corrosion
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:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Zirconium tetrachloride
- EC Number:
- 233-058-2
- EC Name:
- Zirconium tetrachloride
- Cas Number:
- 10026-11-6
- Molecular formula:
- Cl4Zr
- IUPAC Name:
- zirconium tetrachloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test system
- Duration of treatment / exposure:
- from 0 to 240 minutes
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: mean breakthrough time
- 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 |
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.
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