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EC number: 603-837-5 | CAS number: 134605-64-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to guideline; under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-(allyloxy)-2-methyl-1-oxopropan-2-yl 2-chloro-5-[3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihydropyrimidin-1(2H)-yl]benzoate
- EC Number:
- 603-837-5
- Cas Number:
- 134605-64-4
- Molecular formula:
- C20H18ClF3N2O6
- IUPAC Name:
- 1-(allyloxy)-2-methyl-1-oxopropan-2-yl 2-chloro-5-[3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihydropyrimidin-1(2H)-yl]benzoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: solid (tan powder)
- Storage condition of test material: stored at room temperature.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Hra:(NZW)SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Recognised animal supplier.
- Age at study initiation: Not reported.
- Weight at study initiation: 2553 - 2948 g
- Housing: housed in screen-bottom stainless steel cages
- Diet (e.g. ad libitum): Certified rabbit diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 50 +/- 20
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12h light/12h dark
IN-LIFE DATES: From: To: 1995-07-11 to 1995-07-15
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 61 mg (0.1 ml weight equivalent).
VEHICLE
- Amount(s) applied (volume or weight with unit): The test material was administered as received.
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity: n/a - Duration of treatment / exposure:
- The eyes of the rabbits in Group 1 remained unflushed immediately after treatment while the treated eyes of the rabbits in Group 2 were flushed with lukewarm tap water for 1 minute starting 30 seconds after test material instillation.
- Observation period (in vivo):
- The treated eyes of both groups were observed for ocular irritation at 1, 24, 48, and 72 hours after treatment. Additional observations were made at 96 hours after treatment for the animals in Group 1. Irritation was graded and scored according to the Draize technique using a penlight as the source of illumination. A sodium fluorescein examination was used to aid in revealing possible corneal injury at 24 hours.
- Number of animals or in vitro replicates:
- Five male and four female rabbits were used in total. The rabbits were divided into two groups consisting of six rabbits in Group 1 and three rabbits
in Group 2. - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of the rabbits in Group 1 remained unflushed immediately after treatment while the treated eyes of the rabbits in Group 2 were flushed with lukewarm tap water for 1 minute starting 30 seconds after test material instillation.
SCORING SYSTEM: Draize scoring system and ocular irritation scoring scale (based on the method of Draize).
TOOL USED TO ASSESS SCORE: penlight and fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Average Primary eye irritation score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 9.7
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: Group 1
- Irritation parameter:
- other: Average Primary eye irritation score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 4
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: Group 1
- Irritation parameter:
- other: Average Primary eye irritation score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 2.7
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: Group 1
- Irritation parameter:
- other: Average Primary eye irritation score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0.3
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: Group 1
- Irritation parameter:
- other: Average Primary eye irritation score
- Basis:
- mean
- Time point:
- other: 96h
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Group 1
- Irritation parameter:
- other: Average Primary eye irritation score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 7.7
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: Group 2
- Irritation parameter:
- other: Average Primary eye irritation score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 2.7
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: Group 2
- Irritation parameter:
- other: Average Primary eye irritation score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Group 2
- Irritation parameter:
- other: Average Primary eye irritation score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: Group 2
- Irritant / corrosive response data:
- All unwashed treated eyes (Group 1) had returned to a normal appearance by 96 hours after treatment. In the treated eyes receiving a washout approximately 30 seconds after instillation (Group 2), the test material produced iridal involvement and slight to moderate conjunctival irritation. All treated eyes in this group returned to a normal appearance by 48 hours after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material produced very mild eye irritating effects which fully reversed by 96h.
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the eye following a single application in the New Zealand White rabbit. The study was performed to GLP and the method was designed to meet the requirements of EPA Guideline 81 -4. A total of 9 animals were used and split into two groups with group 1 containing 6 animals and group 2 containing 3 animals. A volume of 0.1 ml (61mg) of the test material was placed into the conjunctival sac of the right eye of all 9 animals. The left eye remained untreated and was used for control purposes. The eyes of the rabbits in Group 1 remained unflushed immediately after treatment while the treated eyes of the rabbits in Group 2 were flushed with lukewarm tap water for 1 minute starting 30 seconds after test material instillation. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. Additional observations were made at 96 hours after treatment for the animals in Group 1. Irritation was graded and scored according to the Draize technique using a penlight as the source of illumination. A sodium fluorescein examination was used to aid in revealing possible corneal injury at 24 hours.
In the group 1 test animals, no corneal effects (opacity) were noted during the study. Iridial inflammation (grade 1) was noted for four animals at one hour. Minimal to moderate (grade 1 to 2) conjunctival irritation was noted for all animals one hour after treatment and at the 24 to 72 -hour observations. All treated eyes appeared normal at the 96h observation. In the group 2 test animals, no corneal effects (opacity) were noted during the study. Iridial inflammation (grade 1) was noted in 1 animal at one hour. Minimal to moderate (grade 1 to 2) conjunctival irritation was noted for all animals one hour after treatment and at the 24 -hour observations. All treated eyes appeared normal at the 48h observation. The test material produced a maximum group mean score of 9.7. Based on these results and according to the classification scheme of Kay and Calandra (1962), the test material is mildly irritating to eyes unwashed immediately after treatment and minimally irritating to eyes receiving a washout after treatment. The test material is considered to be non irritating according to the Commission Directive 93/21/EEC.
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