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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2009-10-06
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

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:
Corrositex TM is a quantitative in vitro corrosivity test. The model is based on the time required for the test substance to pass through a biobarrier membrane and produce a change in a chemical detection system.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium Hydroxide monohydrate
EC Number:
603-454-3
Cas Number:
1310-66-3
Molecular formula:
H3LiO2
IUPAC Name:
Lithium Hydroxide monohydrate
Details on test material:
- Name of test material: Lithium hydroxide monohydrate
- Physical state: solid
- Analytical purity: 58.1 %;

In vitro test system

Test system:
artificial membrane barrier model
Details on test system:
SOURCE AND COMPOSITION OF MEMBRANE BARRIER USED
- Was the Corrositex® test kit used: Yes

WAS THE COMPATIBILITY TEST PERFORMED: Yes, test substance produced a change in colour when applied directly into the vial with CDS.

WAS THE TIMESCALE CATEGORY TEST PERFORMED: The test substance was placed into Vial A (containing an acid buffer) and Vial B (containing a base buffer), and the vials were observed for a colour change. A colour change observed in either vial is matched to a colour chart. Vial A showed a yellow color and vial B a grey colour. Based on the colour the substance was considered as category 2 substance and therefore was tested according to Category 2 test criteria.

METHOD OF DETECTION
- Indicator solution: Chemical Detection System (CDS) is composed of water and pH indicator dyes.

NUMBER OF REPLICATES: 4

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the test substances penetrates the membrane barrier in up to 60 min.
- The test substance is considered to be non-corrosive to skin if the penetration time is below 60 min.
- Justification for the selection of the cut-off point(s): According to Corrositex packing group assignment (please also refer to "any other information on materials and methods incl. tables")
Control samples:
yes, concurrent vehicle
yes, concurrent positive control

Test system

Details on study design:
The international Corrositex assay kit is an In vitro method for determining the corrosive potential of chemical substances. The results of this assay were used to determine the United Nations Transport Regulations Packaging Group. For detailed test procedure see Sect. "Any other information on materials and methods incl. tables"

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
A
Value:
21.93
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
B
Value:
19.88
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

Any other information on results incl. tables

Two runs have been performed:

Run C:

Sample Nr.

1

2

3

4

Detection Time hr:min:sec

00:21:55

00:22:27

00:22:07

00:22:13

Start Time

00:00:00

00:00:10

00:00:20

00.00:30

CORROSITEX Time

00:21:55

00:22:17

00:21:47

00:21:43

Convert to Minutes

21.92

 22.28

21.78

21.72

Mean of 4 Replicates

21.93

 

Run D:

Sample Nr.

1

2

3

4

Detection Time hr:min:sec

00:23:10

00:24:24

00:22:22

00:25:52

Start Time

00:03:45

00:03:58

00:04:08

00.04:25

CORROSITEX Time

00:19:25

00:20:26

00:18:14

00:21:27

Convert to Minutes

19.42

 20.43

18.23

21.45

Mean of 4 Replicates

19.88

 

According to the results of the Corrositex TM Assay, the test article, lithium hydroxide monohydrate, has to be classified as corrosive and allocated to packing group II according to the UN Dangerous Goods Transport Regulations

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
A Corrositex TM Assay with Lithium hydroxide monohydrate was performed. Lithium hydroxide monohydrate was found to be corrosive.
Executive summary:

The potential of lithium hydroxide monohydrate to cause dermal corrosion was assessed by a single topical application of the test substance to the Corrositex® Biobarrier Membrane (Corrositex® assay) equivalent or similar to OECD guideline 435. The Corrositex® Biobarrier Membrane is a test system consisting of a reconstituted collagen matrix. The assay is based on the time that is required for the test substance to penetrate through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection System (CDS). In addition to the test substance a positive and a negative control were assessed. The Corrositex® assay showed the following results: The qualification screen demonstrated that the test substance is able to react with the CDS and produce a visible color change. Therefore the membrane barrier test method was determined to be suitable for the evaluation of the corrosive potential of the test substance. In each test run four Corrositex® Biobarrier Membranes were treated with the test substance. The mean breakthrough time of the test substance was below 30 min. Based on the observed results it was concluded, that lithium hydroxide monohydrate was found to be corrosive. Lithium hydroxide monohydrate has to be classified as corrosive Cat . 1B (H314) according to Regulation (EC) No 1272/2008 (CLP).