Registration Dossier
Registration Dossier
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EC number: 242-978-3 | CAS number: 19344-29-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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
Test material
- Reference substance name:
- 3-[(2-hydroxyethyl)amino]propanol
- EC Number:
- 242-978-3
- EC Name:
- 3-[(2-hydroxyethyl)amino]propanol
- Cas Number:
- 19344-29-7
- Molecular formula:
- C5H13NO2
- IUPAC Name:
- 3-[(2-hydroxyethyl)amino]propan-1-ol
- Details on test material:
- - Name of the test substance used in the study report: 3-(2-Hydroxyethylamino)-1-propanol
- Physical state: liquid, viscous, achromatic
- Storage condition of test material: Room temperature
- Analytical purity: 99.3 g/100 g
- Lot/batch No.: Abl. Nr. 61-1853
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. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: Young adult animal
- Weight at study initiation: 3.21 kg
- Housing: Single housing in stainless steel wire mesh cages, floor area: 3000 cm2. No bedding in the cage, sawdust in the waste tray.
- Diet: Kliba-laboratory diet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g/animal/day)
- Water: Drinking water (about 250 mL tap water/animal/day)
- Acclimation period: At least 1 week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes: fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL unchanged substance - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- APPLICATION:
Single application to the conjunctival sac of the right eyelid
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with tap water 24 hours after application
SCORING SYSTEM:
1 h, 24 h, 48 h, 72 h and 8 days after application the effects were scored according to OECD guideline 405 AND EEC L 383A, B.5
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritant / corrosive response data:
- Findings after 1 hours: pupil contracted, discharge of blood
Findings after 24 hours: pupil contracted, discharge of blood, greyish discoloration of the conjunctiva
Findings after 48 hours: suppuration, small retractions in the eyelids, pupil contracted, discharge of blood, loss of corneal tissue, greyish discoloration of the conjunctiva
Findings after 72 hours: suppuration, small retractions in the eyelids, pupil contracted, discharge of blood, loss of corneal tissue, greyish-whitish discoloration of the conjunctiva
Findings after 8 days: suppuration, small retractions in the eyelids, loss of hair at margins of eyelids, pupil contracted, marginal vascularization of the cornea, pannus
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
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