Registration Dossier
Registration Dossier
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EC number: 470-130-4 | CAS number: 697235-49-7
Toxicological information
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-11-17 to 2005-12-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study Deviation from OECD 405(2012), which are not considered to have an effect on the study results: The guideline recommends the use of topical anaesthetics and systemic analgesics during the study. This procedure was not used during this study. In addition, the guideline states that the animals should be observed several times during the first days. During this study the animals were observed daily only.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 2002-04-24
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- , 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2005-04-15
Test material
- Reference substance name:
- -
- EC Number:
- 470-130-4
- EC Name:
- -
- Cas Number:
- 697235-49-7
- Molecular formula:
- Hill formula: C16H15NO4 CAS formula: C16H15NO4
- IUPAC Name:
- 2-((3-(4-Hydroxyphenyl)propanoylamino)benzoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: crystalline powder
- Molecular formula: C16H15NO4
- Molecular weight: 285.3 g/mole
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, branch Löhndorf, Löhndorf/Post Wankendorf, Germany
- Age at study initiation: approx. 4.5 months
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: for 8 hours following test item application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded Irritation of the eye by excrements and urine. During the acclimatisation period and after the 8-hour period in restrainers, the animals were kept singly in cages with dimensions of 400 mm x 500 mm x 370 mm (manufacturer: Dipl.ing. W. EHRET GmbH, Schönenwalde, Germany)
- Diet (ad libitum): ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, Soest, Germany)
- Water (ad libitum): tap water
- Acclimation period: at least 20 adaptation day
ENVIRONMENTAL CONDITIONS
- Temperature: 20°C ± 3°C (maximum range)
- Relative humidity: 30% - 70% (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control. - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- prior to the administration and 1, 24, 48, 72 hours and 4 to 6 days after the administration
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the eyes were rinsed several times with portions of 20 mL 0.9% aqueous NaCI solution.
- Time after start of exposure: 24 hours after administration
SCORING SYSTEM: according to the Draize scale
Any further lesions are Iisted.
Body weight of all animals was measured at the beginning of the study. Behaviour and food consumption were monitored.
TOOL USED TO ASSESS SCORE: the eyes were examined ophthalmoscopically with a slit lamp. 24 hours after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 24 hour fluorescein test: corneal staining (1/2 to 3/4 of the surface
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: Secretion was observed.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Corneal opacity (grade 1) was observed in one animal 24 and 48 hours after instillation. The fluorescein test performed 24 hours after instillation revealed corneal staining in this animal (1/2 to 3/4 of the surface). Irritation of the iris (grade 1) was also observed in this animal 24 hours after instillation. In addition, secretion was observed in this animal 1 hour after instillation.
Conjunctival redness was observed in one animal 24 hours (grade 2), 1 hour and 48 hours to 5 days (grade 1) after instillation and in the remaining two animals 1 hour to 72 hours (grade 1) after instillation.
Conjunctival chemosis was observed in one animal 24 hours (grade 3), 1 hour (grade 2) and 48 hours to 4 days (grade 1) after instillation. In another animal the conjunctival chemosis was observed 1 hour and 24 hours (grade 1) after instillation and in third animal 1 hour (grade 1) after instillation. - Other effects:
- There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to the eyes.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as eye irritating.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as eye irritating.
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