Registration Dossier
Registration Dossier
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EC number: 430-110-8 | CAS number: 183476-82-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 07 - 10, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to GLP principles and followed international recommendations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69/EEC, B.5
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): Nikkol VC-IP
- Substance type: Colourless to light yellow transparent liquid
- Physical state: Liquid
- Stability under test conditions: stable
- Storage condition of test material: In refrigerator in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands.
- Age at study initiation: Approx. 8 weeks
- Housing: Individually in labeled cages with perforated floors
- Diet (e.g. ad libitum): approximately 100 grams per day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye of each rabbit remained untreated and served as the reference control
- Amount / concentration applied:
- 0.1 ml of the test substance
- Duration of treatment / exposure:
- The eyes of the test animals have not been washed.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: according to OECD 405
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: Mean value of score at 24, 48 and 72 h after installation
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days
- Other effects:
- None.
Any other information on results incl. tables
NIKKOL VC-IP was considered minimally irritating (M1) to the rabbit eye (Kay and Calandra interpretation of the calculated maximum Draize score: 3.3).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- NIKKOL VC-IP is not considered irritating when applied to the rabbit eye.
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