Sodium 2-hydroxypropane-2-sulphonate

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, FRG
- Age at study initiation: About 8 months
- Weight at study initiation: 3.86 - 3.99 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

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: undiluted

Duration of treatment / exposure:

The substance was washed out with tap water about 24 hours after application (before 24 hours reading).

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 (2 females, 1 male)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with tap water
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to OECD gudeline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Slight conjunctival redness (grade 1) was observed in 1 animal only 24 hours after application. No other ocular findings were noted. The ocular reaction was reversible in the animal within 48 hours after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, iris lesions and chemosis and 0.0, 0.0 and 0.3 for redness of the conjunctiva.

Any other information on results incl. tables

Individual ocular examinations and mean values (24, 48, 72 hours):

Readings	Animal	Cornea		Iris	Conjunctiva
		Opacity	Area of cornea involved		Redness	Chemosis	Discharge
1 h	01	0	0	0	0	0	0
	02	0	0	0	0	0	0
	03	0	0	0	0	0	0
24 h	01	0	0	0	0	0	0
	02	0	0	0	0	0	0
	03	0	0	0	1	0	0
48 h	01	0	0	0	0	0	0
	02	0	0	0	0	0	0
	03	0	0	0	0	0	0
72 h	01	0	0	0	0	0	0
	02	0	0	0	0	0	0
	03	0	0	0	0	0	0
Mean	01	0.0		0.0	0.0	0.0
	02	0.0		0.0	0.0	0.0
	03	0.0		0.0	0.3	0.0
Mean		0.0		0.0	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 eye under the test conditions chosen.

Executive summary:

The potential of Natrium-2-hydroxypropan-2-sulfonat to cause damage to the conjunctiva, iris or cornea was assessed in 3 White New Zealand rabbits, subjected to a single ocular application of 0.1 ml of the test substance. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Slight conjunctival redness was observed in 1 animal only 24 hours after application. No other ocular findings were noted. The ocular reaction was reversible in the animal within 48 hours after application. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis and 0.1 for conjunctival redness. Considering the described ocular reaction as well as the average score for irritation, Natrium-2-hydroxypropan-2-sulfonat does not give indication of an irritant property to the eye under the test conditions chosen.