Registration Dossier
Registration Dossier
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EC number: 942-166-5 | CAS number: -
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: OECD Guideline Study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid
- EC Number:
- 942-166-5
- Cas Number:
- 922708-02-9
- Molecular formula:
- not applicable
- IUPAC Name:
- Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid
- Reference substance name:
- Glyceryl behenate/isostearate/eicosadioate
- IUPAC Name:
- Glyceryl behenate/isostearate/eicosadioate
- Test material form:
- solid: pellets
- Details on test material:
- - Name of test material (as cited in study report): Nomcort SG
- Substance type: organic
- Physical state: solid
- Analytical purity: not stated
- Lot/batch No.: L060725
- Expiration date of the lot/batch: July 25, 2009
- Stability under test conditions: not stated
- Storage condition of test material: room temperature, airtight
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Yonam College of Agriculture
- Age at study initiation: 17 weeks
- Weight at study initiation: 2.00 - 2.17 kg
- Housing: individual
- Diet: purina experimental diet for rabbit, ad libitum
- Water: filtered and sterilized drining water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 - 21.6
- Humidity (%): 42.2 - 64.1
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- preparation: The substance was ground to a fine powder - Duration of treatment / exposure:
- no washing after instillation was performed
- Observation period (in vivo):
- 1 hour, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
not performed
SCORING SYSTEM: according to Draize method, eye irritation range by Kay and Calandra method.
TOOL USED TO ASSESS SCORE: not stated
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- other: Opacity and Area score taken together
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animal #2, #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- other: animal #2, #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- other: animal #2, #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.16
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- see table above
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was not considered as an irritant. The slight effects were interpreted as mechanical irritation caused by the physical shape of the test item.
- Executive summary:
This study was designed to examine the eye irritation effects of Nomcort SG. The test substance in 100% was administered to three healthy male New Zealand White (Yac:NZW(KBL)) rabbits.
In the initial test, 0.1 g of the test substance was administered to the conjunctival sac of the right eye in one animal. In 24 hours, mild irritant effect was observed, so the confirmatory test was conducted using two additional animals. The eye irritation of the test substance was calculated according to the Draize's method; and eye irritation range was classified by the method of Kay and Calandra.
As a result, 1 hour after the administration, score 1 for conjunctival redness, chemosis and discharge were observed. After 24 hours, score 1 for conjunctival redness (3 animals) and score 1 for discharge (1 animal) were observed. However, it was recovered to normal at 48 hours after the administration.
Abnormal clinical signs and body weight changes by the test substance were not observed in all animals during the observation period.
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