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Registration Dossier
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EC number: 478-910-6 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-03-013 - 2007-05-02 (experimental interval)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Study according to OECD Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Directive 2004/73/EC, B.5
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glyceryl Behenate/Eicosandioate
- IUPAC Name:
- Glyceryl Behenate/Eicosandioate
- Reference substance name:
- -
- EC Number:
- 478-910-6
- EC Name:
- -
- Cas Number:
- 215322-01-3
- Molecular formula:
- C114H218O12 for the stoichiometric product
- IUPAC Name:
- Reaction product of Eicosanedioic acid, Docosanoic acid and Glycerin
- Test material form:
- solid: pellets
- Details on test material:
- Nature of substance: solid
- Name of test material (as cited in study report): Nomcort HKG
- Substance type: organic
- Physical state: solid
- Analytical purity: 100 %
- Lot/batch No.: 5-11-B
- Expiration date of the lot/batch: 29.04.2007
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: at room temperature (range of 20 +- 5 °C), light protected
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: Harlan Netherlands BV
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 2300-2536 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30 - 70%
- 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:
- 0.1 g
- Duration of treatment / exposure:
- no rinsing of test item was done
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to the numerical scoring system listed in Commission Directive 2005/73/EC
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 78 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 2 days
- Other effects:
- Mortality and Clinical Signs: No clinical signs of systemic toxicity and no mortailty occurred. Irritation: No abnormal findings were observed in the treated eye of any animal after 48 hours treatment. However, after 1 hour instillation slight reddening of the conjunctivae, sclerae and slight swelling (chemosis) of the conjunctivae was observed in 3 animals. Reddening of the conjunctivae persisted in 1 animal at 24 hour Coloration: White remnants of the test item were observed in the eye at the 1-hour reading. Corrosion: No corrosion of the cornea was observed at any of the reading times.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, Nomcort HK-G is not irritating to the eye
- Executive summary:
The primary eye irriation potential of Nomcort HKG was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation. The mean score was caldulated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, sparately. The individual mean scores for corneal opacity and iris were 0.0 for all three animals. The individual mean scores for the conjunctivaed were 0.33, 0.00 and 0.00 for reddening, respectively and 0.00 for chemosis in all animals.
The instillation of Nomcort HKG into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 48 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. White test item remnants was present in two animals at the 1 hour reading.
No clinical signs were observed.
Thus, the test item did not induce significant or irreversible damage to the rabbit eye.
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