Reaction mass of tetramethylammonium hypochlorite and tetramethylammonium chloride

Endpoint summary

Description of key information

Skin irritation: Corrosive (in vitro)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

GLP compliance:

no

Species:

other: in vitro

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.

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)

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

The pH of the Halo Salt was determined by electrometric measurement using a pH meter equipped with a glass electrode as the sensor. The pH at 19 deg. C is 12.3 for 10 % water solution, and 14.2 for the neat sample (Williams, C. 2014). In case classification is based upon consideration of pH alone Skin Corr. 1A should be applied. However, in vitro test has been conducted to confirm an appropriate corrosive hazard class (Skin Corr. 1C H314) (Shu, A. 2003).

Skin irritation

The Halo Salt was analysed by the Corrositex method (OECD 473) to determine its corrosive potential (Shu, A. 2003). The original objective of the study was to analyse the corrosive potential of target substance 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 was required to destroy the synthetic biobarriers. Based on this result, the Halo Salt is classified as Corrosive category 1C according to GHS. The study was considered reliable and was conducted according to the guideline OECD 473 but not in compliance with GLP.

Eye irritation

No data available. Based on the Corrositex study result of the Halo Salt solution the substance is classified as corrosive to skin (Skin Corr. 1C) with the risk of eye damage. According to the column 2 of REACH Annex VIII no testing for eye irritation is required.

Respiratory irritation

In general, a classification for corrosivity is considered to implicitly cover the potential to cause respiratory tract irritation. As there is no evidence from animal studies or from human experience that the Halo Salt would cause respiratory tract irritation when inhaled at exposure concentrations below those causing frank respiratory tract corrosion no STOT-SE Category 3 (respiratory tract irritation) classification is warranted. In fact, exposure of humans via inhalation to the target substance is not likely due to its low vapour pressure.

Justification for selection of skin irritation / corrosion endpoint:
The reliable in vitro guideline study (Corrositex) is conducted for the target substance

Justification for selection of eye irritation endpoint:
The substance is classified as Skin. Corr. 1C with risk of eye damage based upon the result of Corrositex study.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the in vitro study result, the Halo Salt has to be classified as a hazard class Skin Corr. 1C H3134 with the risk of serious damage to the eyes according to CLP Regulation 1272/2008 and as C; R34 according to Directive 67/548/EEC.