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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium 3-sulphonatopropyl acrylate
EC Number:
250-465-0
EC Name:
Potassium 3-sulphonatopropyl acrylate
Cas Number:
31098-20-1
Molecular formula:
C6H10O5S.K
IUPAC Name:
potassium 3-(prop-2-enoyloxy)propane-1-sulfonate
Details on test material:
- Name of test material (as cited in study report): SPA, sulfopropyl acrylate
- Physical state: white powder
- Analytical purity: no data
- Lot/batch No.: 0200014/001
- Storage condition of test material: room temperature, in the dark
-pH: 5.4 in a 10% w/w aqueous solution

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.