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EC number: 618-780-1 | CAS number: 916809-14-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April - June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (from the competent authority) Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht Rheinland-Pfalz
Test material
- Reference substance name:
- Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide
- EC Number:
- 700-457-2
- Molecular formula:
- Unspecified
- IUPAC Name:
- Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 8712 / 056
- Purity: 99.6 g / 100 g
- pH value: ca. 5 (undiluted test substance, moistened with water)
FORM OF APPLICATION
undiluted
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- A 1077 INRA (SPF)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: 3 - 4 months
- Weight at study initiation: 2.63 - 3.04 kg
- Housing: The animals were housed in fully air-conditioned rooms.
- Diet (e.g. ad libitum): Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): The animals were housed in fully air-conditioned rooms.
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (about 31 mg of the comminuted test substance) - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 28 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): About 24 hours after application of the test substance the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: 24 hours
SCORING SYSTEM: The evaluation of eye irritation was performed according to the quoted guideline. In addition to specific observations recommended by the regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.
TOOL USED TO ASSESS SCORE: daylight tubes "Lumilux"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Slight corneal opacity (grade 1) was observed in all animals 24 and 48 hours after application and persisted in two animals until the 72 hour reading. Moderate iritis (grade 1) was observed in all animals 24 hours after application and in one animal again after 72 hours. Moderate conjunctival redness (grade 2) was noted in all animals from 1 hour up to 72 hours after application. Moderate or marked conjunctival chemosis (grade 2 or 3) was noted in all animals 1 hour after application. Slight or moderate conjunctival chemosis (grade 1 or 2) was observed in all animals at the 24- and 48-hour reading. Slight conjunctival chemosis was seen in two animals after 72 hours. Slight to severe discharge (grade 1 to 3) was noted in all animals from 1 hour up to 24 hours. Moderate discharge (grade 2) was observed in a single animal after 48 hours. Slight discharge was noted in two animals after 72 hours.
Additional findings like contracted pupil and injected scleral vessels in a circumscribed area or circular were noted in all animals during the observation period.
The ocular reactions were reversible in all animals within 7 days after application.
Any other information on results incl. tables
Table 1: Irritant response data for each individual animal at each observation time as well as calculation of the means
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
||||
1 h |
01 |
0 |
0 |
0 |
2 |
2 |
2 |
49 |
02 |
0 |
0 |
0 |
2 |
3 |
3 |
49 |
|
03 |
0 |
0 |
0 |
2 |
3 |
2 |
49 |
|
24 h |
01 |
1 |
4 |
1 |
2 |
1 |
1 |
PC, 49 |
02 |
1 |
3 |
1 |
2 |
2 |
3 |
PC, 48 |
|
03 |
1 |
4 |
1 |
2 |
2 |
1 |
PC, 48 |
|
48 h |
01 |
1 |
2 |
0 |
2 |
1 |
0 |
PC, 48 |
02 |
1 |
2 |
0 |
2 |
2 |
2 |
PC, 48 |
|
03 |
1 |
3 |
0 |
2 |
1 |
0 |
PC, 48 |
|
72 h |
01 |
1 |
2 |
1 |
2 |
1 |
1 |
PC, 49 |
02 |
0 |
0 |
0 |
2 |
1 |
1 |
48 |
|
03 |
1 |
2 |
0 |
2 |
0 |
0 |
PC, 48 |
|
7 d |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
|
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Mean 24 – 72 h |
01 |
1.0 |
|
0.7 |
2.0 |
1.0 |
|
|
02 |
0.7 |
|
0.3 |
2.0 |
1.7 |
|
|
|
03 |
1.0 |
|
0.3 |
2.0 |
1.0 |
|
|
|
Mean |
|
0.9 |
|
0.4 |
2.0 |
1.2 |
|
|
48: scleral vessels injected, circumscribed area
49: scleral vessels injected, circular
PC: pupil contracted
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Considering the described ocular reactions as well as the average score for irritation, the test substance shows a slight eye irritation potential under the test conditions chosen.
- Executive summary:
The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL bulk volume (about 31 mg) of the test substance to one eye of three New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About 24 hours after application the eye was rinsed with tap water.
The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application and on day 7.
Slight corneal opacity, moderate iritis, moderate conjunctival redness, slight to marked conjunctival chemosis and slight to severe discharge were observed in the animals during the course of the study.
Additional findings like contracted pupil and injected scleral vessels in a circumscribed area or circular were noted in the animals during the observation period.
The ocular reactions were reversible in all animals within 7 days after application.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.9 for corneal opacity, 0.4 for iris lesions, 2.0 for redness of the conjunctiva and 1.2 for chemosis.
Considering the described ocular reactions as well as the average score for irritation, the test substance shows a slight eye irritation potential under the test conditions chosen.
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