Phosphinic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2013/11/22 to 2013/12/19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study following OECD guideline without deviation

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2013

Report date:

2013

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)

Remarks:

2012/11/30

Test material

Test material information

Constituent 1

Reference substance name:

Phosphinic acid

EC Number:

228-601-5

EC Name:

Phosphinic acid

Cas Number:

6303-21-5

Molecular formula:

H3O2P

IUPAC Name:

phosphinic acid

Test material form:

other: 50% aqueous solution of Hypophosphorous acid

Test animals

Species:

other: Biobarrier membrane (reconstituted collagen matrix)

Strain:

not specified

Test system

Amount / concentration applied:

500 µL

Duration of treatment / exposure:

240 minutes

Observation period:

The vials were observed continuously for the first 10 minutes, and at approximate 5 minute intervals for 240 minutes (Category 1 test items) or until breakthrough of the test item had occurred.

Details on study design:

Negative Control: Citric Acid, prepared as a 10% w/v solution
+ Batch: 117130
+ Purity: 99.5%
+ Expiry Date: 15 March 2015
+ Storage Conditions: room temperature

Positive Control: Sulphuric Acid
+ Batch: 1331156
+ Purity: >95%
+ Expiry Date: 15 March 2018
+ Storage Conditions: room temperature

Qualification Screen
The qualification screen was used to determine whether the assay was suitable for the test item. For the qualification screen 150 μL of the test item was added to the "Qualify" test tube. If the test item failed to produce a color or physical change in the qualifying test within five minutes, it cannot be analyzed with the CORROSITEX®.

Categorization Screen
The categorization screen was used to enable the test item to be measured against the appropriate classification scale. Test items having high acid/alkaline reserves are defined as ‘Category 1’ items, while those with low acid/alkaline reserves are defined as ‘Category 2’ items.
The screen was performed by adding 150 μL of the test item to each tube (A and B). Each tube was agitated and the resulting colours observed. The categorisation kit and colour chart provided by In Vitro International were used to determine the category.

Biobarrier Preparation
The membrane discs were prepared three days prior to the assay and were refrigerated at 2 to 8 °C overnight before use. Biobarriers are stable for seven days if wrapped and stored at 2 to 8 °C.
A scintillation vial containing the biobarrier matrix powder was placed in a water bath on a hot plate set at 68 to 70 °C, with the stir switch set to maintain a steady rate for the stir-bar. The entire contents of the biobarrier diluent vial were added slowly to the biobarrier matrix powder to ensure complete and uniform solubilisation. The solution was warmed to 68 to 70 °C to solubilise the biobarrier matrix.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: Breakthrough Time

Value:

12

Remarks on result:

other:

Remarks:

Basis: other: cells viability. Max. score: 240.0. Reversibility: not reversible. Remarks: the test was stopped after 12 minutes and 5 secondes because of the corrosion effects. (migrated information)

Any other information on results incl. tables

Qualification Screen

The test item produced an immediate color change and therefore qualified for use in the CORROSITEX® assay.

Categorization Screen

The test item was assigned into Category 1

The results of the test:

	Vial 1	Vial 2	Vial 3	Vial 4
Start time (hr:min:sec)	00:00:00	00:04:00	00:05:00	00:06:00
Detection time (hr:min:sec)	00:12:00	00:17:30	00:16:30	00:17:20
Breakthrough time (hr:min:sec)	00:12:00	00:13:30	00:11:30	00:11:20

Mean Breakthrough time of the four test item replicates: 12 minutes 05 seconds

Positive/Negative Controls Quality Criteria

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 (weight %)	Breakthrough Time (hr:min:sec)
Positive control	Sulphuric acid	95-98	00:01:08
Negative control	Citric Acid	10	No breakthrough observed

 

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was considered to be CORROSIVE. The following classification criteria apply:
UNITED NATIONS PACKING GROUP II.
EU CLP code H314 hazard category 1B

Executive summary:

The Corrositex® assay is a standardized and quantitative in vitro corrosivity test. The potential corrosivity of the test item was assessed by measuring the time that is required for the test item to pass through a biobarrier membrane and produce a change in a Chemical Detection System (CDS).

4 vials of 50% Hypophosphorous acid solution used in the test. According to the results (average breakthrough point: 12 min 05 sec) the substance is considered to be CORROSIVE. The following classification criteria apply:

UNITED NATIONS PACKING GROUP II.

EU CLP code H314 hazard category 1B