Registration Dossier
Registration Dossier
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EC number: 428-790-6 | CAS number: 72963-72-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 17 - January 20, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 428-790-6
- EC Name:
- -
- Cas Number:
- 72963-72-5
- Molecular formula:
- C17H22N2O4
- IUPAC Name:
- [2,5-dioxo-3-(prop-2-yn-1-yl)imidazolidin-1-yl]methyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropane-1-carboxylate; [2,5-dioxo-3-(prop-2-yn-1-yl)imidazolidin-1-yl]methyl (1R,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropane-1-carboxylate
- Test material form:
- liquid: viscous
- Details on test material:
- Name: Imiprothrin
Appearance: viscous liquid
Colour: amber
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Sex: Female. All animals assigned to test were nulliparous and non-pregnant.
Age/Body Weight: Young adult (13-14 weeks)/2798-2955 grams at experimental start.
Housing: The animals were singly housed in suspended stainless steel caging respectively.
Animal Room Air Changes/Hour: 12. Airflow measurements are evaluated regularly and the records are kept on file at Product Safety Labs.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 20 or 27 days
Food/water: ad libitum
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- One-tenth of a milliliter of the test substance
- Observation period (in vivo):
- Ocular irritation was evaluated using a white light source in accordance with the Draize method of scoring at 1, 24, 48, and 72 hours post-instillation.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Prior to instillation, 1-2 drops of ocular anesthetic (Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%) were placed into both the treated and control eye of each animal. One-tenth of a milliliter of the test substance was then instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance.
The other eye of each rabbit remained untreated with the test substance and served as a control. The rabbits were then returned to their designated cages.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Approximately ninety minutes after test substance instillation, two treated eyes exhibited „positive‟ conjunctivitis and one treated site exhibited minimal conjunctivitis.
There was no corneal opacity or iritis observed in any treated eye during this study.
The overall incidence and severity of irritation decreased with time.
Positive irritation cleared from all three treated eyes by 24 hours.
All animals were free of ocular irritation by 72 hours. - Other effects:
- All animals appeared active and healthy during the study. Although one animal lost body weight, the two remaining animals gained body weight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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