Sodium 2-hydroxypropane-2-sulphonate

Endpoint summary

Description of key information

skin: not irritating

eye: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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

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

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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

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

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

3

Reversibility:

fully reversible within: 48 hours

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.

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

 

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

skin irritation:

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.

eye irritation:

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.

Justification for classification or non-classification

Based on the results, the test item is no subject to classification and labelling according to Regulation (EC) No 1272/2008 (CLP).