Registration Dossier
Registration Dossier
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EC number: 252-650-1 | CAS number: 35636-63-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 17 FEB 2004 to 27 FEB 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to Guideline (OECD 405) and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dimethyl 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]terephthalate
- EC Number:
- 252-650-1
- EC Name:
- Dimethyl 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]terephthalate
- Cas Number:
- 35636-63-6
- Molecular formula:
- C21H19N5O7
- IUPAC Name:
- dimethyl 2-({2-oxo-1-[(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)carbamoyl]propyl}diazenyl)terephthalate
- Test material form:
- solid: nanoform
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: single in air conditioned room, cages arranged in battery
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 24 h after application washing was performed
- Observation period (in vivo):
- 72 h with observation time points at 1, 24, 48 and 72 h.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with isotonic saline at approx. 37 °C.
- Time after start of exposure: 24 h
SCORING SYSTEM: according to the score of Draize
TOOL USED TO ASSESS SCORE: not indicated, at the 24 and 72 h reading fluorescein was used additionally
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #2 and #3 each
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Irritant / corrosive response data:
- Individual animal data for 1/24/48/72 h after application, animal #1, animal #2 animal #3:
cornea: 0/0/0/0, 0/0/0/0, 0/0/0/0
iris: 1/0/0/0, 0/0/0/0, 0/0/0/0
conjunctivae redness: 2/2/0/0, 2/0/0/0, 2/0/0/0
chemosis: 2/0/0/0, 1/0/0/0, 1/0/0/0
discharge: 2/0/0/0, 2/0/0/0, 2/0/0/0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) 1272/2008
- Conclusions:
- The test item did not reveal any remarkable irritation potential on the eyes of rabbits, tested in this study according to OECD test guideline no. 405 and GLP conditions.
- Executive summary:
The primary eye irritation potential of the test item was investigated according to OECD test guideline no 405.The test item was applied by instillation of 0.1 g into the left eye of each of three young New Zealand White rabbits. The scoring of irritating effects was performed 1, 24, 48 and 72 hours after test item instillation.
The test item did not induce corneal effects under the conditions of this test. Effects on iris, conjunctivae redness and chemosis were sligtht to moderate (maximum score observed: iris =1; chemosis = 2 (1 -hour reading); conjunctival redness = 2 (1- and 24 - hour reading)) and fully reversible within 48 hours after start of the exposure.
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