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EC number: 255-255-2 | CAS number: 41198-08-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 November 2005 to 12 November 2005
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12 Nouan No. 8147 (2000)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
- EC Number:
- 255-255-2
- EC Name:
- O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
- Cas Number:
- 41198-08-7
- Molecular formula:
- C11H15BrClO3PS
- IUPAC Name:
- 4-bromo-2-chlorophenyl ethyl (propylsulfanyl)phosphonate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 72hr post dosing
- Number of animals or in vitro replicates:
- 1 male and 2 female rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
Any other information on results incl. tables
Findings are summarised below
Table 7.3.2-1: Eye irritation scores according to the Draize scheme
Time/ Rabbit |
Rabbit 1 |
Rabbit 2 |
Rabbit 3 |
|||||||||
|
Hours |
Hours |
Hours |
|||||||||
|
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
I. Cornea |
||||||||||||
A. Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
B. Area |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
(AxB)x5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
II. Iris |
||||||||||||
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Ax5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
III. Conjunctivae |
||||||||||||
A. Redness |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
B. Chemosis |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
C. Discharge |
3 |
1 |
0 |
0 |
3 |
1 |
0 |
0 |
3 |
1 |
0 |
0 |
(A+B+C)x2 |
12 |
4 |
0 |
0 |
12 |
4 |
0 |
0 |
12 |
4 |
0 |
0 |
Total |
12 |
4 |
0 |
0 |
12 |
4 |
0 |
0 |
12 |
4 |
0 |
0 |
Additional criteria in Directive 93/21/EEC Point 3.2.6.2 fulfilled: Yes
All animals appeared active and healthy during the study apart from the eye irritation noted, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
No corneal opacity or iritis was noted for any treated eye during the study. One hour after test material instillation conjunctivitis was noted for all three treated eyes. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation within 72 hours.
The maximum mean total score of Profenofos Technical was 12.0
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, Profenofos Technical is classified as mildly irritating to the eye.
- Executive summary:
In a primary eye irritation study, 0.1 mL Profenofos Technical (undiluted) was instilled into the conjunctival sac of the right eye of three young adult New Zealand White rabbits. The left eye acted as a control. Animals were then observed for 3 days. Irritation was scored using the Draize scheme for unwashed eyes, with the system of Kay and Calandra used to classify the test material.
All animals appeared active and healthy during the study apart from the eye irritation noted, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
No corneal opacity or iritis was noted for any treated eye during the study. One hour after test material instillation conjunctivitis was noted for all three treated eyes. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation within 72 hour
Based on the results of this study, Profenofos Technical is classified as mildly irritating to the eye.
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