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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:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study, OECD compliance. However, no certificate of analysis are available
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes (incl. QA statement)
Remarks:
2000-04-26

Test material

Constituent 1
Reference substance name:
ALBRITE CS1
IUPAC Name:
ALBRITE CS1
Constituent 2
Reference substance name:
Phosphonium, tetrakis(hydroxymethyl)-, sulphate (2:1) (salt), polymer with urea.
EC Number:
613-239-6
Cas Number:
63502-25-0
Molecular formula:
Not applicable
IUPAC Name:
Phosphonium, tetrakis(hydroxymethyl)-, sulphate (2:1) (salt), polymer with urea.
Test material form:
other: liquid
Details on test material:
Name as used in study report: ALBRITE CS1 (Albrite CS1 was the commercial name of Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea).

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 to 16 years old
- Weight at study initiation: 2.65 to 3.26 kg
- Housing: Individually housed in suspended metal cages
- Diet (e.g. ad libitum): free access to STANRAB SQC Rabbit diet, special diet services Ltd, Witham, Essex, UK
- Water (e.g. ad libitum): Free access

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 °C to 23 °C
- Humidity (%): 30 % to 70 %
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): cycle 12h/12h. Light from 6am to 6 pm

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Observation period (in vivo):
1, 24, 48 and 72 hours. 7 and 14 days
Number of animals or in vitro replicates:
3 (1 female and 2 males)
Details on study design:
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examinated for evidence of ocular irritation or defect with the aid of a light source from a standard ophtalmoscope. Only animals free of ocular damage were used.

Initially, a single rabbit was treated. A volume of 0.1 mL of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about 1 second immediately after treatment to prevent loss of test material, and then released. The left eye remained untreated and was used for control purposes.

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

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 hours
Remarks on result:
other:
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 14 days

Any other information on results incl. tables

Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex

BW: kg

128 Female (3.26) +

116 Male (3.03) +

117 Male (2.65) +

Time after treatment

1h

24h

48h

72h

7d

14d

1h

24h

48h

72h

7d

1h

24h

48h

72h

7d

CORNEA

E = Degree of opacity

0

1

1

0

0

0

0

0

0

0

0

0

0

0

0

0

F = Area of opacity

0

1

1

0

0

0

0

0

0

0

0

0

0

0

0

0

Score (E x F) x 5

0

5

5

0

0

0

0

0

0

0

0

0

0

0

0

0

IRIS

D

0

1

1

0

0

0

0

1

0

0

0

0

0

0

0

0

Score (D x 5)

0

5

5

0

0

0

0

5

0

0

0

0

0

0

0

0

CONJUNCTIVAE

A = Redness

2

2P

2P

2P

2P

0

2

2

2

2

0

2

2

2

2

0

B = Chemosis

2

2

2

2

1

0

2

2

2

2

0

1

2

2

1

0

C = Discharge

2

2

2

2

1

0

1

2

2

2

0

2

2

2

2

0

Score (A + B + C) x 2

12

12

12

12

8

0

10

12

12

12

0

10

12

12

10

0

Total Score

12

22

22

12

8

0

10

17

12

12

0

10

12

12

10

0

+ = One drop of Amethocaine hydrochloride instilled into each eye 1 to 2 minutes prior to dosing

P = Pale appearance of the nictating membrane

Individual Total Scores and Group Mean Scores for Ocular Irritation

Rabbit Number

Individual Total Scores at:

1h

24h

48h

72h

7 days

128

12

22

22

12

0

116

10

17

12

12

0

117

10

12

12

10

0

Group total

32

51

46

34

8

Group Mean score

10.7

17.0

15.3

11.3

2.7

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the test conditions of this study, The mean individual scores were 0.66/0.0/0.0, 0.66/0.33/0.0, 2.0/2.0/2.0 and 2.0/2.0/1.66 for cornea, iris, conjunctivae redness and chemosis respectively. These effects were reversible after 14 days. Based on these results, the test substance is considered as irritating to eyes.
Executive summary:

In an eye irritation study performed according to the OECD No. 405 guideline and in compliance with the GLP, 0.1 mL of undiluted Albrite CS1 (commercial name of Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea) was instilled into the conjunctival sac of the right eye of 3 New Zealand White rabbits. The eyes were not rinsed after administration of the test substance.

Ocular reactions were observed approximately 1, 24, 48 and 72 hours, 7 and 14 days after the administration.The mean individual score were calculated within 3 scoring times (24, 48 and 72 hours).

The mean individual scores were 0.66/0.0/0.0, 0.66/0.33/0.0, 2.0/2.0/2.0 and 2.0/2.0/1.66 for cornea, iris, conjunctivae redness and chemosis respectively. These effects were reversible after 14 days.

Under the test conditions of this study, i Albrite CS1 (commercial name of Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea) s considered as irritating to eyes.