Registration Dossier
Registration Dossier
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EC number: 404-360-3 | CAS number: 119313-12-1 CG 25-369; IRGACURE 369; TK 11-319
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-04-28, 1987-05-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
- EC Number:
- 404-360-3
- EC Name:
- 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
- Cas Number:
- 119313-12-1
- Molecular formula:
- C23 H30 N2 O2
- IUPAC Name:
- 2-benzyl-2-(dimethylamino)-1-[4-(morpholin-4-yl)phenyl]butan-1-one
- Details on test material:
- - Substance type: Organic
- Physical state: Solid
- Purity: Lab. sample
- Lot/batch No.: WR 629
- Expiration date of the lot/batch: 1990-12
- Storage condition of test material: Room temperature, in the dark
- Other: Insoluble in water
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks
- Weight at study initiation: 2190 - 2420 g
- Housing: Individually in metal cages
- Diet: Ad libitum, standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: Ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as control.
- Amount / concentration applied:
- 0.1 mL of undiluted test material (corresponding to 38 mg) was applied.
- Duration of treatment / exposure:
- 72 h; The treated eye was not rinsed.
- Observation period (in vivo):
- 1, 24, 48, 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The irritant/corrosive potency was scorred according to the EEC commission directive No. 83/467, 1983. For further details see additional information.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Corneal opacity graded 1 was observed 1 h after application.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Corneal opacity graded 1 was observed 1 h after application.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Iritis graded 1 was observed 1h after application.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Redness of conjunctiva graded 1 was observed 1 h after application.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Conjunctival redness graded 2 was observed 1 h after application.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Chemosis graded 1-2 was observed 1 h after application.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Chemosis graded 1-2 was observed 1 h after application.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Chemosis graded 1-2 was observed 1 h after application.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material invoked no meaningful indications of irritation over the duration of the test. The test material is not considered an eye irritant.
- Executive summary:
In this guideline (OECD 405) study conducted to GLP standards, the test material (EC 404-360-3) was determined to be not irritating to eyes. Undiluted test material (0.1 ml, corresponding to 38 mg) was applied directly to an eye of three rabbits with the other eye of each being the control. The conditions of the eyes were then observed at 1, 24, 48 and 72 hours. At 1 hour, only slight effects graded 1 or 2 were observed. After 24 hours conjunctival redness graded 1 was observed in one animal only, this was fully reversible over the duration of the test. Thus, according to CLP regulation 1272/2008, this substance is not classified for eye irritation.
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