Potassium 3-sulphonatopropyl acrylate

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating

Eye irritation (OECD 405): 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

Study period:

31 Jul - 03 Aug 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: animals were individually housed in suspended metal cages
- Diet: STANRAB SQC Rabbit Diet (Special Diets Services Limited, Witham, Essex, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

the test substance was moistened with 0.5 mL distilled water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): the test material was moistened with 0.5 mL distilled water

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: the test site was covered with a 2.5 x 2.5 cm cotton gauze patch that was held in place with a strip of surgical adhesive tape. The trunk of the rabbits was then wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing: the test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system. The test sites were examined 1, 24, 48 and 72 hours after the exposure ended.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

There were no skin irritation effects observed in any of the animals at reference time points 1, 24, 48 and 72 h. All scores for erythema and edema were 0 at all reference time points.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of the study, the test substance was not irritating to the skin of New Zealand White rabbits.

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

Study period:

07 - 22 Aug 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: animals were individually housed in suspended metal cages
- Diet: STANRAB SQC Rabbit Diet (Special Diets Services Limited, Witham, Essex, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL, weighing approximately 88 mg

Duration of treatment / exposure:

The treated eye was not washed

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48 and 72 h, and 7 days

Number of animals or in vitro replicates:

3

Details on study design:

Initially, 1 animal was treated. After assessing the ocular response in the first animal, 2 additional animals were treated. In order to minimise pain on application of the test material, one drop of local anaesthetic (Amethocaine hydrochloride 0.5%, Chauvin Pharmaceuticals, Romford, Essex, UK) was instilled into both eyes of these animals 1-2 minutes before treatment.

The test substance was placed into the conjunctival sac of the right eye and the upper and lower lids were then held together for 1 second to prevent loss of the test substance. The left eye remained untreated and was used as a control. Immediately after the treatment, the pain reaction was assessed using a 6 point scale. Assessment of ocular damage was made approximately 1, 24, 48 and 72 hours and 7 days after treatment.

REMOVAL OF TEST SUBSTANCE
- Washing: the eye was not washed after treatment

SCORING SYSTEM: Draize scoring system.

TOOL USED TO ASSESS SCORE: opthalmoscope

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 72 h

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

A dulling of the normal lustre of the cornea was noted in all treated eyes at the 1-hour time point. Diffuse corneal opacity was noted in two treated animals 24 hours after treatment and in one animal at the 48-hour time point. Iridial inflammation was seen in all treated eyes at the 1- and 24-hour time point, persisting in one eye until the 48-hour observation. Moderate conjuntival irritation was observed in all treated eyes after 1, 24 and 48 hours, with minimal to moderate irritation still present at the 72-hour time point. Areas of haemorrhage (approximately 2 mm x 2 mm) were noted on the nictitating membrane on one animal at the 24, 48 and 72-hour observations. All treated eyes were normal within 7 days.

Table 1. Individual results of the eye irritation study.
Rabbit #	Time [h]	conjunctivae		iris	cornea		conjunctivae		iris	cornea
		redness	swelling				redness	swelling
1	1	2	2	1	0 d
	24	2 H	2	1	1
	48	2 H	2	1	1
	72	2 H	2	0	0
	7 d	0	0	0	0
	average	2	2	0.67	0.67	Time to reversion	7 d	7 d	72 h	72 h
2	1	2	2	1	0 d
	24	2	2	1	1
	48	2	1	0	0
	72	1	1	0	0
	7 d	0	0	0	0
	average	1.67	1.33	0.33	0.33	Time to reversion	7 d	7 d	48 h	48 h
3	1	2	2	1	0 d
	24	2	2	1	0
	48	2	1	0	0
	72	1	1	0	0
	7 d	0	0	0	0
	average	1.67	1.33	0.33	0.0	Time to reversion	7 d	7 d	48 h	24 h

Average = mean of 24 + 48 + 72 h scores

d: dulling of the normal lustre

H: area of haemorrhage (app. 2 mm x 2 mm) on the nictating membrane

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of the study, the test substance induced some mild irritancy to the eye of New Zealand White rabbits. However, the slight signs of irritation observed were fully reversible after 7 days and were not sufficient to warrant classification for eye irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A study assessing the skin irritation potential of sulfopropyl acrylate (SPA) was performed according to OECD 404 (Driscoll, 2001). 0.5 g of the moistened test substance was applied under semiocclusive conditions for 4 hours. There were no skin irritation effects observed in any of the animals at reference time points 1, 24, 48 and 72 h. The scores for erythema and edema were 0 at all reference time points.

To evaluate the eye irritation potential of SPA, a study was performed according to OECD 405 (Driscoll, 2001). 0.1 mL of the test substance was instilled into one eye of 3 rabbits, and the eye remained unwashed. The irritating effect was assessed 1, 24, 48 and 72 h and 7 days after the treatment. Diffuse corneal opacity was noted in 2/3 treated animals 24 hours after treatment, persisting in one of these animals to the 48-hour time point. The corneal damage was reversed within 72 hours. Inflammation of the iris was seen in all treated eyes at the 1- and 24-hour time point. In 1/3 animals the effect was visible for 48 hours, but had cleared completely within 72 hours. Moderate conjuntivitis was observed in all treated eyes after 1, 24 and 48 hours, with minimal to moderate irritation still present at the 72-hour time point in 3/3 animals. Areas of haemorrhage were noted on the nictitating membrane (third eyelid) of 1/3 animals at the 24, 48 and 72-hour observations. The effects on the eyes of all the rabbits were completely reversible within 7 days.

Justification for classification or non-classification

The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.