Sodium 2-hydroxypropane-2-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-hydroxypropane-2-sulphonate

EC Number:

208-761-2

EC Name:

Sodium 2-hydroxypropane-2-sulphonate

Cas Number:

540-92-1

Molecular formula:

C3H8O4S.Na

IUPAC Name:

sodium 2-hydroxypropane-2-sulphonate

Details on test material:

- Name of test substance: Natrium-2-hydroxypropan-2-sulfonat
- CAS No.: 540-92-1
- Batch No.: 13./14.01.2001
- Date of manufacturing: Jan. 13/14, 2001
- Physical state/appearance: Liquid/colorless-clear
- Degree of purity/content: The degree of purity of the test substance was found to be 13 g/100 g. The content of water was found to be 87.2 g/100 g.
- Homogeneity: The test substance was homogeneous by visual inspection.
- Stability: The stability of the test substance has not been determined by reanalysis, because the study and the characterization were performed in the same time period.
- Storage conditions: Room temperature, exclusion of oxygen (storage under nitrogen)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, FRG
- Age at study initiation: About 8 months
- Weight at study initiation: 3.80 - 3.92 kg
- Housing: Single housing in wire mesh cages with grating, floor area 3000 cm²
- Diet: Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: undiluted

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: Upper third of the back or flanks, area of 2.5 cm x 2.5 cm
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece; Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Slight erythema (grade 1) was observed in all animals on the day of application and persisted only in 1 animal up to day 1. No edema was noted. The cutaneous reactions were reversible in all animals within 48 hours after removal of the patch at latest. Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema.

Any other information on results incl. tables

Individual cutaneous examinations and mean values:

Readings	Animal	Exposure period: 4 h
		Erythema	Edema
1 h	01	1	0
	02	1	0
	03	1	0
24 h	01	1	0
	02	0	0
	03	0	0
48 h	01	0	0
	02	0	0
	03	0	0
72 h	01	0	0
	02	0	0
	03	0	0
Mean (24, 48, 72 h)	01	0.3	0.0
	02	0.0	0.0
	03	0.0	0.0
Mean (24, 48, 72 h)		0.1	0.0

Applicant's summary and conclusion

Conclusions:

Natrium-2-hydroxypropan-2-sulfonat does not give indication of an irritant property to the skin under the test conditions chosen.

Executive summary:

The potential of Natrium-2-hydroxypropan-2-sulfonat to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 ml of the test substance to the intact skin of 3 White New Zealand rabbits for 4 hours under semiocclusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed approximately 1, 24, 48 and 72 hours after removal of the patch. Slight erythema was observed in all animals on the day of application. No edema was observed. The cutaneous reactions were reversible in all animals within 48 hours after removal of the patch at latest.

The average score (24 to 72 hours) for irritation was calculated to be 0.1 for erythema and 0.0 for edema. Considering the described cutaneous reactions as well as the average score for irritation, Natrium-2-hydroxypropan-2-sulfonat does not give indication of an irritant property to the skin under the test conditions chosen.