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Registration Dossier
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EC number: 249-528-5 | CAS number: 29232-93-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 Jun 1999 to 27 Jun 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pirimiphos-methyl
- EC Number:
- 249-528-5
- EC Name:
- Pirimiphos-methyl
- Cas Number:
- 29232-93-7
- Molecular formula:
- C11H20N3O3PS
- IUPAC Name:
- O-2-(diethylamino)-6-methylpyrimidin-4-yl O,O-dimethyl phosphorothioate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adults
- Weight at study initiation: 2842- 3495 g
- Housing: The rabbits were housed individually, in cages suitable for animals of this strain and the weight range expected during the course of the study.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15 changes
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 8 Jun 1999 To: 27 Jun 1999
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL of the test substance
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 1 female and 2 males
- Details on study design:
- SCORING SYSTEM:
The eyes were examined and the Draize scale was used to assess the grade of ocular reaction approximately one hour and 1, 2 and 3 days after instillation. In addition, as an aid in the assessment of corneal damage, fluorescein staining was used at all readings from 1 day after instillation.
TOOL USED TO ASSESS SCORE: As an aid to assessment of the eye, all animals were placed in an artificial daylight chamber each time the eyes were examined. Both eyes of each rabbit were examined the day before dosing, The examination consisted of a visual assessment with the aid of fluorescein and only rabbits without any apparent eye defects or ocular irritation were used. Immediately after the instillation of the test substance, an assessment of the initial pain reaction of the rabbit was made using a six-point scale.
OTHER EXAMINATIONS:
- General health: Throughout the study, the animals were observed daily for general signs of well-being.
- Body weight: The animals were weighed prior to the start of the study.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1d
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2d
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2d
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were no corneal or iridial effects. Conjunctival effects consisted of slight redness in all three animals for up to 2 days, slight chemosis in one animal approximately 1 hour after instillation and a slight discharge in all three animals approximately 1 hour after instillation. There were no additional signs of irritation. All signs of irritation had completely resolved 3 days after instillation.
- Other effects:
- - Clinical observations:
There were no signs of ill-health in any animal during the study. Instillation into the eye caused practically no initial pain (class 1 on a 0-5 scale).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test substance was considered to be not irritating to the eyes of rabbits.
- Executive summary:
A primary eye irritation test was conducted with male and female New Zealand White rabbits, in accordance with GLP and OECD TG 405, to determine the irritation potential of the substance after a single instillation into the eye. The test substance (0.1 mL) was instilled into one eye of each of the rabbits and an assessment of initial pain was made. The eyes were examined for 3 days, to assess the grade of ocular reaction.
Instillation into the eye caused practically no initial pain. The mean irritation scores for the time points after 24/48/72 hours were determined to be 0 for all animals for corneal opacity and iritis. For conjunctivae redness these scores were 0, 0.33 and 0.67 for animal 1 to 3. For chemosis these scores were 1, 0 and 0 for animal 1 to 3. Conjunctiva effects consisted of slight redness and a slight discharge in three animals, and slight chemosis in one animal. There were no additional signs of irritation. All signs of irritation had completely resolved 3 days after instillation.
Under the conditions of this study, the test substance was considered to be not irritating to the eyes of rabbits.
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