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Description of key information

In accordance with column 2 of REACH Regulation 1907/2006/EC Annex VII section 8.1 and 8.2 in-vitro studies for skin corrosion/ irritation and eye irritation do not need to be conducted if the available information indicates that the criteria are met for classification as corrosive to the skin and eyes. Lithium hydroxide anhydrous and its monohydrate are corrosive due to their chemical properties (strong alkaline substances). Thus, respective studies are not required.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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)
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 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
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"
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

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

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).

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2009-10-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar 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 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
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"
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
A
Value:
25.42
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:
21
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

Two runs have been performed:

Run A:

Sample Nr.

1

2

3

4

Detection Time hr:min:sec

00:25:50

00:25:50

00:25:50

00:25.50

Start Time

00:00:00

00:00:48

00:01:55

00.02:57

CORROSITEX Time

00:25.50

00:25:02

00:23:55

00:22:53

Convert to Minutes

25.83

 25.03

23.92

22.88

Mean of 4 Replicates

24.42

 

Run B:

Sample Nr.

1

2

3

4

Detection Time hr:min:sec

00:26:00

00:28:30

00:28:30

00:26.00

Start Time

00:04:36

00:05:43

00:06:52

00.07:50

CORROSITEX Time

00:21:24

00:22:47

00:21:38

00:18:10

Convert to Minutes

21.40

 22.78

21.63

18.17

Mean of 4 Replicates

21.00

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

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
A Corrositex TM Assay with lithium hydroxide anhydrous was performed. Lithium hydroxide anhydrous was found to be corrosive. Based on this data, this substance is found to be classified.
Executive summary:

The potential of lithium hydroxide anhydrous 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 anhydrous was found to be corrosive. Lithium hydroxide anhydrous has to be classified as corrosive Cat . 1B (H314) according to Regulation (EC) No 1272/2008 (CLP).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In accordance with column 2 of REACH Regulation 1907/2006/EC Annex VII section 8.1 and 8.2 in-vitro studies for skin corrosion/ irritation and eye irritation do not need to be conducted if the available information indicates that the criteria are met for classification as corrosive to the skin and eyes.

Lithium hydroxide anhydrous and its monohydrate are corrosive. Thus, respective studies are not required.

For classification, the results of CORROSITEX assays with lithium hydroxide anhydrous and lithium hydroxide monohydrate were considered.

Based on this data, lithium hydroxide anhydrous and lithium hydroxide are to be classified

- corrosive: Cat . 1B (H314 - causes severe skin burns and eye damage) according to Regulation (EC) No 1272/2008 (CLP)

Lithium hydroxide anhydrous and its monohydrate were found to be corrosive to skin and eye and assigned to packing group II.

Justification for classification or non-classification

Based on the available data, lithium hydroxide anhydrous and lithium hydroxide monohydrate are to be classified as

- corrosive to skin: Cat . 1B (H314) according to Regulation (EC) No 1272/2008 (CLP) and

- corrosive to eyes: Cat 1 (H318) according to Regulation (EC) No 1272/2008 (CLP) and