Registration Dossier
Registration Dossier
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EC number: 938-153-9 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 10-December 19, 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-[(2S,3S)-2-(benzyloxy)pentan-3-yl]-4-{4-[4-(4-{[(3R,5R)-5-(2,4-difluorophenyl)-5-[(1H-1,2,4-triazol-1-yl)methyl]oxolan-3-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one
- EC Number:
- 938-153-9
- Molecular formula:
- C44H48O4N8F2
- IUPAC Name:
- 1-[(2S,3S)-2-(benzyloxy)pentan-3-yl]-4-{4-[4-(4-{[(3R,5R)-5-(2,4-difluorophenyl)-5-[(1H-1,2,4-triazol-1-yl)methyl]oxolan-3-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one
- Details on test material:
- White powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd. UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.72-3.11 kg
- Fasting period before study: yes
- Housing: suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):17-20 C
- Humidity (%): 48-65%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: December 10, 1998 To:December 18, 1998
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Observation period (in vivo):
- 1, 24, 48, 72 hours after treatment
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- To minimise the pain after treatement 1 drops of proxymetacaine HCL was added added 1 to 2 mins after treatment
SCORING SYSTEM: Svoring based on standard Draize system and classification based on a modified Kay and Calandra scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- > 13.6 - < 13.8
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- > 4.6 - < 4.8
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- > 0 - < 0.1
- Reversibility:
- fully reversible within: 72 hour
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect noted
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- no coreneal effect were noted. Iridial inflamation was confined to one treatment eye one hour after exposue. moderate conjunctival irritation was noted in all eyes one hours after treatment which regressed to minimal in all animals at 72 hours. All eyes appreared normal after 48 hours.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a mean scoreof 13.7 and was classified as a minimal irriant (class 3 on a 1 - 8 scale) but not classified per the CLP regulation.
- Executive summary:
The test material did not meet the criteria for classification as an irritant according to CLP regulations.
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