Hydroxylamine-O-sulphonic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hydroxylamine-O-sulphonic acid

EC Number:

220-971-6

EC Name:

Hydroxylamine-O-sulphonic acid

Cas Number:

2950-43-8

Molecular formula:

H3NO4S

IUPAC Name:

(aminooxy)(hydroxy)sulfane dioxide

Details on test material:

- Name of test material (as cited in study report):Hydroxylamine-O-sulphonic acid
- Physical state: soid/white
- Analytical purity: 96.8 g/100 g
- Lot/batch No.: 14-0007
- pH-value: Ca. 0.8 (100 g/L, information given from safety data sheet) Ca. 1 (undiluted test substance, moistened with water) (value determined with test strips in the laboratory)

Test animals

Species:

other: in vitro

Strain:

other: in vitro

Test system

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): undiluted

Duration of treatment / exposure:

up to 4 hours or until break through

Observation period:

Test substance: 3 min to 4 hours until break through
Negative control: 60 min
Positive control: continuosly until break through

Details on study design:

4 tests were performed for the test item, one test for the positive, negative and the color (blank) control. The experimental design of this study consisted of a qualification screen with the CDS (to determine if a color change can be detected) and a categorization screen (to categorize weak acids/bases and strong acids/bases), which were performed as a pretest, and a definitive Corrositex® assay.
The Corrositex® assay was evaluated on the basis of the color change of the CDS. The time that a color change was observed was recorded manually and the breakthrough times of the four replicates was used to determine the corrosive potential of the test substance. For the qualification screen, 100 mg of the test substance was added to the CDS screening tube. If the test substance failed to produce a color change in the CDS within one minute, the test substance could not be analyzed in this system, and no further testing was required.
In addition, one vial was used for the PC, NC and for the color (blank) control, each. A membrane disc coated with the biobarrier matrix was placed into one vial containing the CDS and 500 mg of the undiluted test substance was added onto the membrane disc. An electronic time clock was started with the application. The vial was observed for three minutes for any change in the CDS.
If no color change was observed within three minutes, the remaining membranes were treated with the test substance. An electronic time clock was started with each application. The vials were observed continuously for the first ten minutes. Thereafter the vials were observed for approximately ten minutes around the time points relevant for evaluation or until breakthrough of the test substance occurred. The elapsed time between test-substance application and the first change in the indicator solution (i.e. barrier penetration) was recorded.

The categorization screen was used to assess the appropriate scoring scale for the test substance. he categorization screen was performed by adding 100 mg of test substance to each tube A and B. Each tube was mixed and the resulting color observed. If required, 2 drops of the "confirm" reagent were added to tube B, the tube mixed, and the resulting color observed. The categorization kit and color chart provided by InVitro International were used to determine the category. The test substance was scored as category 1 (high acid/alkaline reserve) or category 2 (low acid/alkaline reserve)

Results and discussion

Any other information on results incl. tables

 Breakthrough times of the test substance and the PC and NC

Test substance	Break Through Time[min:s]
	Vial 1	Vial 2	Vial 3	Vial 4	Mean
03/0169-3	5:18	5:19	4:51	4:18	4:57
Controls:
PC: Sodium hydroxide, solid	10:44	-	-	-	-
NC: 10% citric acid	NB	-	-	-	-

NB = no breakthrough within maximum observation period (60 min)