Registration Dossier
Registration Dossier
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EC number: 616-036-0 | CAS number: 73963-42-5
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: This study had been performed in accordance with OECD Giudeline No.:405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-(4-chlorobutyl)-1-cyclohexyl-1H-1,2,3,4-tetrazole
- EC Number:
- 616-036-0
- Cas Number:
- 73963-42-5
- Molecular formula:
- C11H19ClN4
- IUPAC Name:
- 5-(4-chlorobutyl)-1-cyclohexyl-1H-1,2,3,4-tetrazole
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Cilostazol Starting Material 2 (EGIS-15331-1)
- Physical state: white crystalline powder
- Lot/batch No.: PL2488
- Date of analysis: 2009.03.
- Re-test date: 2010.03.
- Storage condition of test material: In well-closed brown vial at up to 25°C.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: TETRABBIT , Hungary
- Weight at the beginning of the study: 2936-3178 g
at the end of the study: 3009-3298 g
- Housing: individually in metal cages.
- Diet (e.g. ad libitum): P. Strenghtened Female Hare (Herba) diet produced by AGRIBANDS
- Water (e.g. ad libitum): Animal received tap water from watering bottles ad libitum.
- Acclimatisation time: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated right eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Dosage: 0.1 g of test item in pure state, as a single dose - Duration of treatment / exposure:
- The eyes of the animals were not washed out after the application of test item.
- Observation period (in vivo):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
no removal
SCORING SYSTEM:
by Draize (1977) and OECD 405 (24 April 2002)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- cornea opacity
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0 - 0.33
- Max. score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- One hour after the single application of test item into the eye of the rabbits slight redness and slight to moderate discharge were observed in the eye of the test animals.
- Other effects:
- One hour after treatment some hyperaemic blood vessels (score 1) were observed in all animals. 24 hour after treatment some hyperaemic blood vessels (score 1) were observed in 1 animal.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, test item applied to the rabbit's eye mucosa, caused cause slight to moderate conjunctival irritant effects, fully reversible within 48 hours. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
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