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EC number: - | CAS number: -
Eye irritation
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
- Reference substance name:
- Tetrakis(hydroxymethyl)phosphonium sulphate (2:1) and its oligomerisation products with urea
- Molecular formula:
- Not applicable
- IUPAC Name:
- Tetrakis(hydroxymethyl)phosphonium sulphate (2:1) and its oligomerisation products 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).
Constituent 1
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.
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