Registration Dossier
Registration Dossier
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EC number: 639-693-5 | CAS number: 180637-88-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 November 1997 to 24 November 1997
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (R)-1-Acetyl-3-(1-methyl-2-pyrrolidinyl methyl)-5-[2-(phenylsulphonyl)vinyl] -1H-indole
- EC Number:
- 639-693-5
- Cas Number:
- 180637-88-1
- Molecular formula:
- C24 H26 N2 O3 S
- IUPAC Name:
- (R)-1-Acetyl-3-(1-methyl-2-pyrrolidinyl methyl)-5-[2-(phenylsulphonyl)vinyl] -1H-indole
- Test material form:
- solid: bulk
- Details on test material:
- brown crystalline solid
Constituent 1
- Specific details on test material used for the study:
- Brown Solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- At the start of the study the animal weighed 2.99 kg and was twelve to sixteen weeks old. After an acclimatisation period of at least five days the animal was given a number unique within the study which was written with a black indelible markerpen on the inner surface of the ear and on a cage label.
The animal was housed in a suspended metal cage. Free access to mains drinking water and food was allowed throughout the study.
The animal room was maintained at a temperature of 16 to 21*C and relative humidity of 46 to 71%. On occasions the temperature and relative humidity were outside the limits specified in the protocol (17°C and 70% respectively).
The rate of air exchange was approximately fifteen changes per hour and the lighting was twelve hours light and twelve hours darkness.
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- A volume of 0.1 ml of the test material, which was found to weigh approximately 58 mg
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. Additional observations were made on Days 7, 14 and 21 to assess the reversibility of the ocular effects
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- A single application of the test material to the non-irrigated eye of one rabbit produced opalescent corneal opacity, iridial inflammation and moderate conjunctival irritation. Vascularisation of the cornea was also noted in the treated eye.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 48 and 72 hr
- Score:
- 15
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 15
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 5
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 27
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 32
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 7, 14 and 21 days
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 14 and 21 days
- Score:
- 5
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 10
- Reversibility:
- not fully reversible within:
- Remarks:
- not reversible within 21 days
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test material, UK-209,947, was considered to be corrosive to the rabbit eye due to irreversible ocular damage (based on one rabbit only). The test material produced positive criteria in the treated rabbit according to EU labelling regulations and was considered to be IRRITANT to the rabbit eye. It is reasonable to assume the symbol "Xi" and highest risk phrase R 41 "RISK OF SERIOUS DAMAGE TO EYES" are therefore required.
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