Registration Dossier
Registration Dossier
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EC number: 426-290-2 | CAS number: 74149-72-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 March 1994 - 27 June 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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:
- -
- EC Number:
- 426-290-2
- EC Name:
- -
- Cas Number:
- 74149-72-7
- Molecular formula:
- C20H20N2O7
- IUPAC Name:
- methyl 4-[4-(4-methoxybenzamido)-3-nitrophenyl]-3-methyl-4-oxobutanoate
- Details on test material:
- - Name of test material (as cited in study report): UD-CG 115 Nitrobenzamide (Gamma-NAP)
- Substance type: monoconstituent
- Analytical purity: 98.9%
- Purity test date: 04 February 1994
- Lot/batch No.: 1/94
- Stability under test conditions: guaranteed until February 1996.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmBH, D-88397 Biberach
- Age at study initiation: males: 99 and 116 days; females: 86 and 92 days
- Weight at study initiation: 2.9 - 3.15 kg
- Housing: solid wire cages in an air-conditioned room
- Diet (e.g. ad libitum): dry food (in pellets Nafag, THOM 5) ad libitum
- Water (e.g. ad libitum): municipal drinking water
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-/ 3°C
- Humidity (%): 45 - 75%
- Air changes (per hr): maximum 16 x/h
- Photoperiod (hrs dark / hrs light): 9/15 hours
IN-LIFE DATES: From: 28 March 1994 To: 30 March 1994.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye of each rabbit served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm3 (20 mg) - Duration of treatment / exposure:
- The lids were held gently together for about one second in order to prevent loss of material.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 4 rabbits (2 males and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM:
Draize scale
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable (no reaction)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable (no reaction)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable (no reaction)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable (no reaction)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable (no reaction)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable (no reaction)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable (no reaction)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable (no reaction)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable (no reaction)
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable (no reaction)
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable (no reaction)
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable (no reaction)
- Irritant / corrosive response data:
- No chemosis was observed in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritant after eye contact under the test conditions of the study.
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