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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:
other: GLP - 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-(acryloyloxy)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 (e.g. ad libitum): 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 (if done): 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:
0.66
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:
0.66
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:
1.66
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.66
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. Results of 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

7 d

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

 

 

 

 

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

avg. time to reversion

7 d

7 d

88 h

48 h

average
score

1

2.00

2.00

1.00

0.00

 

24

2.00

2.00

1.00

0.67

48

2.00

1.33

0.33

0.33

72

1.33

1.33

0.00

0.00

7 d

0.00

0.00

0.00

0.00

24+48+72

1.78

1.55

0.44

0.33

 

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:
CLP: not classified