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EC number: 457-330-7 | CAS number: 66034-17-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 March to 17 March 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 457-330-7
- EC Name:
- -
- Cas Number:
- 66034-17-1
- Molecular formula:
- Hill formula: C4H10N2:H4O7P2 CAS formula: C4H10N2:H4O7P2
- IUPAC Name:
- (phosphonooxy)phosphonic acid; piperazine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species: SPF bred New Zealand White albino rabbits
Supplier: Centre Lagro, France
Sex and age: 3 males, young adult, ca 9 weeks old
Date of arrival: 26 February 2003
Quarantine/acclimatization: 5 days
Body weights at start of study: 1880, 1613 and 1993 g
Body weights at termination: 2100, 1804 and 2250 g
Caging: individually in stainless steel cages with perforated floor
Lighting: 12 hours light/12 hours dark cycle
Temperature during testing: 20 ± 3 °C.
Relative humidity during testing: 30-70%. Upper limit incidentally up to 99.9%, because of meteorological circumstances and/or wet cleaning of the animal room.
Ventilation: ca 10 air changes/hour
Diet/water: standard laboratory diet ad libitum. Each batch of this diet is analysed by the supplier (SDS Special Diets services, Whitham, England) for the nutrients and contaminants and the results are kept available in the archives. Tap water (N.V. Hydron MiddenNederland) ad libitum. Results of routine physical, chemical and microbiological examination of drinking water as conducted by the supplier are kept available in the archives. The results of diet and water analyses were considered acceptable for this study.
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- ca 0.1 ml of the test substance (0.035 g)
- Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The in vitro/ex vivo Non-GLP Chicken Enucleated Eye Test did not show severe signs of irritation. Therefore, it was decided to proceed with the in vivo test. Both eyes of the rabbits selected were examined just before testing. Only rabbits without observable eye defects were used. The study was carried out with three rabbits and each rabbit was treated as follows: An amount of ca 0.1 ml of the test substance (0.035 g) was instilled in the conjunctival cul-de-sac of one of the eyes. After administration, the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye remaining untreated, served as a control. The reactions of the test eyes were judged at circa one, 24, 48, 72 hand at 7 and 14 days after treatment using the scoring scale.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0 - 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 2.7 - 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 1 - 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- At 1 h after treatment, moderate redness and moderate swelling of the conjunctivae and moderate ocular discharge were observed in the three rabbits.
At 24, 48 and 72 h after treatment, slight opacity and slight iritis were observed in one rabbit, while moderate or severe redness and slight or moderate swelling of the conjunctivae and slight, moderate or severe ocular discharge were observed in the three rabbits.
At 7 days after treatment slight redness and moderate swelling of the conjunctivae were still observed in the third rabbit (no. 36). - Other effects:
- At one hour after treatment, amounts of the test substance were still present in the conjunctival cul-de-sac of the rabbits. These remnants were removed by rinsing of the eye with physiological saline.
In addition, a haemorrhage of the conjunctivae and ischemic necrosis (only animal no. 36) were observed in the rabbits at 48 and 72 h after treatment.
At 7 days after treatment, eye effects had cleared in two rabbits.
At 14 days after treatment, eye effects had cleared in the third rabbit as well.
Any other information on results incl. tables
Table 1: Individual scores awarded to the ocular lesions elicited by compound T-1063FM
Animal no. |
Corneal effects |
Iris |
Conjunctivae |
Discharge |
||
Score |
Area |
Redness |
Swelling |
|||
1 HOUR |
||||||
32 |
0 |
0 |
0 |
2 |
2 |
2 |
34 |
0 |
0 |
0 |
2 |
2 |
2 |
36 |
0 |
0 |
0 |
2 |
2 |
2 |
24 HOURS |
||||||
32 |
0 |
0 |
0 |
2 |
1 |
1 |
34 |
0 |
0 |
0 |
3 |
2 |
1 |
36 |
1 |
4 |
1 |
3 |
2 |
2 |
48 HOURS |
||||||
32 |
0 |
0 |
0 |
3* |
1 |
1 |
34 |
0 |
0 |
0 |
3* |
1 |
1 |
36 |
1 |
4 |
1 |
3* |
2 |
3 |
72 HOURS |
||||||
32 |
0 |
0 |
0 |
3* |
1 |
0 |
34 |
0 |
0 |
0 |
3* |
1 |
0 |
36 |
1 |
4 |
1 |
3* |
2 |
3 |
7 Days |
||||||
32 |
0 |
0 |
0 |
0 |
0 |
0 |
34 |
0 |
0 |
0 |
0 |
0 |
0 |
36** |
0 |
0 |
0 |
1 |
2 |
0 |
*=haemorrhage of the lower conjunctivae
**= effects had cleared completely at 14 days after treatment
Table 2: Mean values for corneal opacity, iritis, redness and swelling of the conjunctivae of each rabbit scored at 24, 48 and 72h after treatment with T-1063FM
Animal no. |
Opacity |
Iritis |
Redness |
Swelling |
32 |
0.0 |
0.0 |
2.7 |
1.0 |
34 |
0.0 |
0.0 |
3.0 |
1.3 |
36 |
1.0 |
1.0 |
3.0 |
2.0 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: EU
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