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EC number: 444-090-3 | CAS number: 204848-45-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12-Dec-2002 to 02-Jan-2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD test guideline 405)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted on 24th February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 444-090-3
- EC Name:
- -
- Cas Number:
- 204848-45-3
- Molecular formula:
- C44 H43 N3 O4
- IUPAC Name:
- Propanoic acid, 2-[4-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-3-hydroxyphenoxy]-, isooctyl ester
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Highgate Farm, Market Rasen, Lincolnshire, England
- Age at study initiation: at least 8 weeks
- Weight at study initiation: 2.75-3.17 kg
- Housing: individually in stainless steel cages with perforated floors
- Diet: 125 g of a standard laboratoty rabbit diet per day. A dietary supplement of hay was given during the acclimatisation period until at least two days prior to dose instillation.
- Water: drinking water was provided ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 16-20 °C
- Humidity: 40-70%
- Photoperiod 12 hours dark / 12 hours light
IN-LIFE DATES: not indicated
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 70 mg (corresponding to a volume of 0.1 mL based on specific gravitiy) - Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 8 days. Ocular reactions to treatment were assessed 1, 24, 48 and 72 hours and eight days after treatment.
- Number of animals or in vitro replicates:
- three male
- Details on study design:
- SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992.
TOOL USED TO ASSESS SCORE: ophthalmoscope/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:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Injection of the conjunctival blood vessels or a crimson-red conjunctival appearance with or without very-slight discharge was evident in all animals one hour after instillation. Conjunctival injection or a crimson-red conjunctival appearance was apparent in two animals during the next three days. One animal was overtly normal 24 hours after instillation, the remaining two were overtly normal after one week.
- Other effects:
- - Lesions and clinical observations: There was no sign of toxicity or ill health in any rabbit during the observation period.
- Ophthalmoscopic findings: not determined
- Histopathological findings: not determined
- Effects of rinsing or washing: not applicable
- Other observations: Instillation of the test substance gave rise to practically no or a slight initial pain response.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Installation into the eyes of rabbits caused mild, transient conjunctival irritation which resolved within the post observation period. The substance is therefore not considered to be irritating to eyes.
- Executive summary:
A GLP-compliant Acute eye irritation/corrosion study according to OECD TG 405 was performed to assess the eye irritation potential of the test substance to the rabbit. Three rabbits were each administered a single ocular dose of a volume of 0.1 ml of the test substance weighing approximately 70 mg and observed for eight days after instillation. Injection of the conjunctival blood vessels or a crimson-red conjunctival appearance with or without very-slight discharge was evident in all animals one hour after instillation. Conjunctival injection or a crimson-red conjunctival appearance was apparent in two animals during the next three days. One animal was overtly normal 24 hours after instillation, the remaining two were overtly normal after one week. Instillation of the test substance gave rise to practically no or a slight initial pain response. As only mild, transient conjunctival irritation which resolved within the post observation period was observed, the substance is not considered to be irritating to eyes.
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