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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
key study
Study period:
not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: HaloSalt was evaluated with the Corrositex test method to determine its corrosive potential. The study was considered reliable and was conducted according to the guideline OECD 473 but not in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Not applicable
EC Number:
940-936-5
Molecular formula:
C4H12NCl.C4H12NOCl
IUPAC Name:
Not applicable
Details on test material:
- Name of test material (as cited in study report): XM-224
- Physical state: liquid
- Analytical purity: 100 %
- Lot/batch No.: C2618
- Other: pH 11.6

Test animals

Species:
other: in vitro

Test system

Details on study design:
The Corrositex test was performed in three steps. First, a qualification test was done to insure that the test sample and the chemical detection system (CDS) reagent are compatible. This was achieved by placing either 150 ul of a liquid into an aliquot of the CDS reagent and observing it for the presence of any detectable change. If a physical or color change is observed, the sample is judged to be compatible with the detection solution and the remainder of the test is performed. The second step of the Corrositex test utilizes appropriate indicator solutions to permit categorization of the test sample as either a Category 1 or Category 2 material. Category 1 materials are typically strong acids/bases, while Category 2 materials are typically weak acids/bases. The third step in the test is performed by applying the test sample to the biobarrier. When the chemical permeates through or destroys the full thickness of this biobarrier, it comes into contact with the CDS which then undergoes a simple color change. This color change is visually observed and the time required for the color change to occur is recorded. The time required to destroy the biobarrier is recorded for four sample replicates and the mean of these replicates is utilized to designate the UN Packing Group classification as I (severe corrosivity), II (moderate corrosivity), III (mild corrosivity), or Noncorrosive (NC). Positive and negative controls were analyzed concurrently to confirm the test’s validity.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: other: Colour change in a chemical detection system
Value:
> 60
Remarks on result:
other:
Remarks:
Basis: other: Replicate 1. Remarks: The time required to colour change to occur (min). (migrated information)
Irritation / corrosion parameter:
other: other: Colour change in a chemical detection system
Value:
> 60
Remarks on result:
other:
Remarks:
Basis: other: Replicate 2. Remarks: The time required to colour change to occur (min). (migrated information)
Irritation / corrosion parameter:
other: other: Colour change in a chemical detection system
Value:
> 60
Remarks on result:
other:
Remarks:
Basis: other: Replicate 3. Remarks: The time required to colour change to occur (min). (migrated information)
Irritation / corrosion parameter:
other: other: Colour change in a chemical detection system
Value:
> 60
Remarks on result:
other:
Remarks:
Basis: other: Replicate 4. Remarks: Time required to colour change to occur (min9. (migrated information)

In vivo

Other effects:
The results of this study indicated that the sample was compatible with the Corrositex system and was classified as a Category 2 material.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
HaloSalt was analyzed by the Corrositex method to determine its corrosive potential. The result of this study demonstrated a mean time of > 60 minutes is required to destroy the synthetic biobarrier.
Executive summary:

The original objective of the study was to analyze the corrosive potential of HaloSalt by the Corrositex method and to determine its packing group designation. The results obtained from the evaluation of four replicate samples were highly reproducible, demonstrating that a mean time of > 60 minutes required to destroy the synthetic biobarriers. These findings lead to the designation of this sample as a non-corrosive.

Corrositex method has been granted regulatory approval (OECD test guideline 435) and is used to rank chemicals with respect to their corrosive potential according to globally harmonised system of classification and labelling of chemicals (GHS). Based on the available study result (> 60 min), HaloSalt is classified as Corrosive category 1C according to GHS.

The study is considered as a key study in hazard assessment.