Registration Dossier
Registration Dossier
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EC number: 806-509-1 | CAS number: 1393571-42-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15-04-2013 to 25-04-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study according to the guidelines under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates
- EC Number:
- 806-509-1
- Cas Number:
- 1393571-42-0
- Molecular formula:
- NA
- IUPAC Name:
- Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates
- Reference substance name:
- Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates
- IUPAC Name:
- Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates
- Test material form:
- other: extremely viscous liquid
- Details on test material:
- - Name of test material (as cited in study report): Fatty acids, tall oil, reaction products with fatty acids C16-18 and C18-unsatd, branched and linear, diethylenetriamine and methylhydrogen maleate
- Substance type: UVCB
- Physical state: extremely viscous liquid
- Storage condition of test material: room temperature in dark
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.50 to 2.71 kg
- Housing: individually
- Diet: ad libitum (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon)
- Water; ad libitum
- Acclimation period: minimal 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): ≥15/hr
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL applied to the conjunctival sac of the right eye
- Observation period (in vivo):
- 1, 24, 48 and 72 hour observations
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- ANAESTHETICS AND ANALGESICS
– doses and times when topical anaesthetics and systemic analgesics were administered:
systemic: buprenorphine 0.01 mg/kg sc 60 minutes prior to dosing
local: 0.5% tetracaine hydrochloride (2 drops ineach eye) 5 minutes prior to dosing
systemic: buprenorphine 0.01 mg/kg sc and meloxicam 0.5 mg/kg sc 8 hours after dosing
- interaction with test substance: none reported
- inititial pain score: not reported
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: standard ophthalmoscope (no fluorescein used)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: average 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: average 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: avarage 24-72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: average 24-72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- not irritant
- Other effects:
- No effects on body weight
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test substance is not irritating to the eyes
- Executive summary:
In an in vivo test two rabbits were treated with the test substance (0.1 mL applied in the conjunctival sac of one eye) after systemic and local analgesia/anaesthesia . No signs of irritatiion except for very slight effects on the conjunctivae after 1, 24 and 48 hours became apparent. After 72 hours no effects were noted. Therefore it is concluded that the test substance is not irritating to the eyes.
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