Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 September 1990 - 10 September 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD405 used to draw a conclusion on the non corrosive/ non-irritating properties to the eyes of the tested substance, which differs slightly from registered substance. Compostion of tested substance available from another report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-butylphthalimide
- EC Number:
- 216-157-5
- EC Name:
- N-butylphthalimide
- Cas Number:
- 1515-72-6
- Molecular formula:
- C12H13NO2
- IUPAC Name:
- 2-butyl-1H-isoindole-1,3(2H)-dione
- Reference substance name:
- N-sec-butylphthalimide
- EC Number:
- 233-295-1
- EC Name:
- N-sec-butylphthalimide
- Cas Number:
- 10108-61-9
- Molecular formula:
- C12H13NO2
- IUPAC Name:
- 2-sec-butyl-1H-isoindole-1,3(2H)-dione
- Reference substance name:
- N-propylphthalimide
- EC Number:
- 226-189-1
- EC Name:
- N-propylphthalimide
- Cas Number:
- 5323-50-2
- Molecular formula:
- C11H11NO2
- IUPAC Name:
- 2-propyl-1H-isoindole-1,3(2H)-dione
- Reference substance name:
- Reference substance 006
- Cas Number:
- 120792-34-9
- Reference substance name:
- Reference substance 001
- Cas Number:
- 67762-26-9
- Test material form:
- liquid
- Details on test material:
- Description: dark straw-coloured liquid
Container: plastic screw-top container
Date of arrival: 26 July 1990
Storage conditions: room temperature
Constituent 1
Constituent 2
Constituent 3
additive 1
additive 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approx. 10 - 16 weeks
- Weight at study initiation: 2.42 - 2.85 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum Rabbit Diet, preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 °C
- Humidity (%): 58 - 65%
- Air changes (per hr): Approx. 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml instilled into the conjunctival sac of the right eye
- Duration of treatment / exposure:
- The upper and lower eyelids were held together for about one second immediately after instillation, to prevent loss of the test material, and then released.
- Observation period (in vivo):
- Assessment of ocular damage/imitation was made approximately 1 hour and 24,48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize J.H. 1959, Association of Food and Drug Officials of the United States, Austin, Texas, 'The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope.
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
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- All treated eyes appeared normal at the 24-hour observation.
Mean scores of 0 following gradings at 24, 48 and 72 hours after installation of the test material for corneal opacity, iritis and conjunctivae (3 of 3 tested animals) were observed. - Other effects:
- Minimal conjunctival irritation was noted in all treated eyes one hour after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material Reaction mass of N-butylphthalimide and N-sec-butylphthalimide and N-propylphthalimide did not produce any positive response in an OECD 405 study. Mean scores of 0 at 24, 48 and 72 hours after installation of the test material for corneal opacity, iritis, conjunctivae, and chemosis (3 of 3 tested animals) were observed. The results allows clear decision that the test item is not corrosive and not irritating to the eyes according to the regulation 1272/2008/EC.
- Executive summary:
A study was performed to assess the irritancy potential of the test material Reaction mass of N-butylphthalimide and N-sec-butylphthalimide and N-propylphthalimide to the eye of the New Zealand white rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" referenced as Method 85 in Commission Directive 84/449/EEC.
The results may be used as a basis for classification and labelling according to the regulation 1272/2008/EC after reinterpretation of the data.
A single instillation of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal 24 hours after treatment.
The test material did not produce a positive response in any of the rabbits. Mean scores of 0 following gradings at 24, 48 and 72 hours after installation of the test material for corneal opacity, iritis,
conjunctivae and chemosis (3 of 3 tested animals) were observed. The results allows clear decision that the substance is not corrosive and not irritating to the eyes according to the regulation 1272/2008/EC.
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