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EC number: 939-042-8 | CAS number: 1482217-03-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5th July 2013 - 30th July 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,12-bis({2-[4-(4,6-diphenyl-1,3,5-triazin-2-yl)-3-hydroxyphenoxy]ethyl}) dodecanedioate
- EC Number:
- 939-042-8
- Cas Number:
- 1482217-03-7
- Molecular formula:
- C58H56N6O8
- IUPAC Name:
- 1,12-bis({2-[4-(4,6-diphenyl-1,3,5-triazin-2-yl)-3-hydroxyphenoxy]ethyl}) dodecanedioate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): T-1620L
- Physical state: pale yellow powder
- Analytical purity: 99.9%
- Lot/batch No.: OF1211
- Expiration date of the lot/batch: 30 April 2014
- Storage condition of test material: RT in the dark
- Other:
Constituent 1
- Specific details on test material used for the study:
- - Description: Pale yellow powder
- Storage conditions: 20°C in the dark
- Batch number: OF1211
- Date of receipt: 28th January 2013
- Expiry date: 30th April 2014
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: reputable commercial supplier
- Age at study initiation: 36 - 38 2 weeks
- Weight at study initiation: 3.55 - 4.57 kg
- Housing: plastic cage with perforated floors
- Diet: 125 g of a standard laboratory rabbit diet per day per rabbit
- Water: ad libitum
- Acclimation period: 18 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12h dark/ 12h light
IN-LIFE DATES: From: To: 05 July to 30 July 2013
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL equivalent to ca. 43mg
- Concentration (if solution): as supplied - Duration of treatment / exposure:
- Test substance left in the eye for the duration of the study
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed
- Time after start of exposure: N/A
SCORING SYSTEM:
The occular irritation was assessed using a prescribed numerical system, the untreated eye was used a s a comparison during the assessment process. The classification system of Kay and Calandra (1962) was employed on this study
TOOL USED TO ASSESS SCORE:
Pencil beam torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness of Conjunctiva
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness of Conjunctiva
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness of Conjunctiva
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
Any other information on results incl. tables
There was no sign of toxicity or ill health in any rabbit during the observation period.
A crimson-red conjunctival appearance with very-slight chemosis and, in one case, slight discharge, was evident in all animals one hour after instillation. In two animals injection of the conjunctival blood vessels persisted 24 or 48 hours after instillation after which the eyes were overtly normal. In the remaining animal a beefy-red conjunctival appearance with very slight chemosis, scattered or diffuse areas of opacity covering up to a quarter of the corneal surface and iritis were apparent 24 hours after instillation. The opacity, iritis and chemosis resolved within the next 24 hours by when a crimson-red conjunctival appearance was evident. Injection of the conjunctival blood vessels was apparent 72 hours after instillation, resolving by Day 8. The treated eye of all animals was overtly normal by Day 8. Instillation of the test substance gave rise to a moderate initial pain response in the sentinel animal; subsequent animals were treated with local (ocular) anaesthesia prior to instillation.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The highest total mean score was 7.3 occurring at the 24-hour observation; accordingly under the criteria Kay and Calandra (1962) T-1620L was classified as “minimally irritating” to the eye. T-1620L did not require labelling in accordance with European Commission regulation 1272/2008.
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