Registration Dossier
Registration Dossier
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EC number: 266-358-7 | CAS number: 66423-13-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2002)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octyl (R)-2-(4-chloro-2-methylphenoxy)propionate
- EC Number:
- 266-358-7
- EC Name:
- Octyl (R)-2-(4-chloro-2-methylphenoxy)propionate
- Cas Number:
- 66423-13-0
- Molecular formula:
- C18H27ClO3
- IUPAC Name:
- octyl (2R)-2-(4-chloro-2-methylphenoxy)propanoate
- Reference substance name:
- Mecoprop-P n-octyl ester
- IUPAC Name:
- Mecoprop-P n-octyl ester
- Reference substance name:
- Preventol B5
- IUPAC Name:
- Preventol B5
- Reference substance name:
- R-(+)-2-(4-chloro-2-methylphenoxy)-propionic acid, octyl ester
- IUPAC Name:
- R-(+)-2-(4-chloro-2-methylphenoxy)-propionic acid, octyl ester
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: approx. 4.5 - 5.5 months
- Weight at study initiation: 2.4-2.7 kg
- Housing: singly in cages measuring 380 mm x 425 mm x 600 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, 16352 Schönwalde, Germany)
- Diet and water: ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye, which remained untreated, served as control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- The lids were gently held together for about one second in order to prevent loss of the material. The eye was rinsed approximately 24 hours following instillation.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 0.1 mL of the test item were administered per eye and tested in three animals. The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control. The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours days after the administration. The eye reactions were observed and registered. 24 hours after administration the eyes were treated additionally with fluorescein and examined.
The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Conjunctival redness (grade 1) was observed in all animals 1 hour after instillation, reversible after 24 hours. The corneae and irises were not affected by instillation of the test item.
- Other effects:
- There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Executive summary:
An acute eye irritation/ corrosion test according to OECD TG 405 was conducted with Mecoprop-P n-octyl ester.
Conjunctival redness (grade 1) was observed in all animals 1 hour after instillation, but proved to be reversible after 24 hours. No signs of irritation were observed 24, 48 and 72 hours after treatment.
There were no systemic intolerance reactions.
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